CTSN Embolic Protection Trial (EMPRO)

May 26, 2026 updated by: Annetine Gelijns, Icahn School of Medicine at Mount Sinai

Embolic Protection in Patients Undergoing High-Risk Valve Surgery

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure.

RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will be controlled centrally and performed through a web-based data collection system that automates the delivery of the randomization codes. From the point of treatment assignment, primary efficacy will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignments at randomization regardless of whether or not they actually received the treatment to which they were assigned.

STUDY POPULATION The patient population for this trial consists of patients age ≥ 60 undergoing different types of valve surgery with or without CABG via full or minimal-access sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are listed below. All patients who meet the eligibility criteria may be included in the study regardless of gender, race, or ethnicity.

SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies

The aims of this ancillary sub-study include:

  1. To investigate the association between short sleep duration, less sleep regularity, and greater circadian rhythm disruption prior to surgery and POD within 7 days of VHD surgery.
  2. To investigate the association between short sleep duration, less sleep regularity and greater circadian rhythm disruption (reduced melatonin and cortisol amplitudes) after surgery and POD within 7 days of VHD surgery.

Approximately 300 EMPRO trial participants will be enrolled into the ancillary study. The study is being conducted in highly experienced clinical centers in the U.S. and Canada. The estimated enrollment period is 12-15 months.

All eligible and consented patients in the parent EMPRO trial will be offered enrollment in this ancillary study through the parent trial consent process.

Study Type

Interventional

Enrollment (Estimated)

842

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Michael Chu
      • Ottawa, Ontario, Canada
        • Recruiting
        • University of Ottawa Heart Institute
        • Principal Investigator:
          • Pierre Voisine
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada
      • Québec, Quebec, Canada, QC G1V 4G5
  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • CHI St. Vincent Heart Institute
        • Contact:
        • Principal Investigator:
          • Thurston Bauer
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Hospital of the University of Southern California
        • Contact:
        • Principal Investigator:
          • Vaughn Starnes
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Michael Halkos
        • Contact:
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Withdrawn
        • Indiana University
      • Fort Wayne, Indiana, United States, 46804
        • Withdrawn
        • Indiana Ohio Heart
    • Louisiana
      • New Orleans, Louisiana, United States, 70506
    • Maine
      • Portland, Maine, United States, 04102
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medicine
        • Contact:
        • Principal Investigator:
          • James S Gammie
      • College Park, Maryland, United States, 20742
        • Recruiting
        • University of Maryland
        • Contact:
        • Principal Investigator:
          • Mehrdad Ghoreishi
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Nathaniel Langer
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Gorav Ailawadi
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Principal Investigator:
          • Keith Allen
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Isaac George
      • New York, New York, United States, 21287
        • Recruiting
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Pey-Jen Yu
      • New York, New York, United States, 10065
        • Withdrawn
        • New York Presbyterian-Cornell Medical Center
      • New York, New York, United States, 11220
        • Withdrawn
        • NYU Langone Hospital Brooklyn
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel Goldstein
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Jeffrey Gaca
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Marc Gillinov
      • Cleveland, Ohio, United States, 44106
        • Withdrawn
        • University Hospitals
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Principal Investigator:
          • Michael Acker
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Not yet recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • John Kern
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 60 years

  • Planned de novo or redo:

    • Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG
    • Mitral valve replacement (MVR) ± CABG
    • Mitral Valve Repair + CABG,
    • Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure.
    • Valve sparing aortic root replacement (David procedure)
    • Valve sparing aortic root replacement (David procedure)
  • No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization
  • Ability to provide informed consent and comply with the protocol

Exclusion Criteria:

  • History of clinical stroke within 3 months prior to randomization
  • Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
  • Coronary catheterization within 3 days of index procedure, and the required repeat NIHSS score post-catheterization is worse than the screening/baseline NIHSS score conducted prior to the catheterization
  • Active endocarditis at time of randomization with vegetation criteria
  • Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
  • Participation in an interventional (drug or device) trial
  • Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
  • Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
  • Planned concomitant carotid endarterectomy during index surgical procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CardioGard Embolic Protection Cannula
In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).
Device: CardioGard Embolic Protection Cannula
The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.
Placebo Comparator: Standard Aortic Cannula
In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice
Device: Standard Aortic Cannula
An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
Time Frame: within 3 days post-randomization
The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
within 3 days post-randomization
Number of patients who experience of death and delirium
Time Frame: by 7 days post-randomization
The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).
by 7 days post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who experience a clinical ischemic stroke
Time Frame: within 3 days post-randomization
The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
within 3 days post-randomization
Proportion of patients who experience a clinical ischemic stroke
Time Frame: within 7 days post-randomization
The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
within 7 days post-randomization
Number of patients with disabling clinical stroke
Time Frame: within 3 days post-randomization
Number of patients with disabling clinical stroke within 3 days post-randomization
within 3 days post-randomization
Number of patients with disabling clinical stroke
Time Frame: within 7 days post-randomization
Number of patients with disabling clinical stroke within 7 days post-randomization
within 7 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Time Frame: within 3 days post-randomization

Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.

Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.

These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
within 3 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Time Frame: within 7 days post-randomization

Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.

Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.

These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
within 7 days post-randomization
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Time Frame: at baseline

Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at baseline days.

The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.

5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

6 - Dead.
at baseline
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Time Frame: at 30 days

Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 30 days.

The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.

5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

6 - Dead.
at 30 days
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Time Frame: at 90 days

Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 90 days.

The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.

5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

6 - Dead.
at 90 days
Montreal Cognitive Assessment (MoCA) Score
Time Frame: at baseline

Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at presurgical baseline.

The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
at baseline
Montreal Cognitive Assessment (MoCA) Score
Time Frame: at 90 days

Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 90 days.

The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
at 90 days
Montreal Cognitive Assessment (MoCA) Score
Time Frame: at 12 months

Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 12 months.

The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
at 12 months
Oral Trail Making Test - Parts A and B (executive function)
Time Frame: at baseline
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
at baseline
Oral Trail Making Test - Parts A and B (executive function)
Time Frame: at 90 days post-randomization
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
at 90 days post-randomization
Oral Trail Making Test - Parts A and B (executive function)
Time Frame: at 12 months post-randomization
The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Time Frame: baseline
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
baseline
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Time Frame: at 90 days post-randomization
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
at 90 days post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Time Frame: at 12 months post-randomization
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)
Time Frame: at baseline
The WAIS-R Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test that consist of number-symbol pairs. It requires the examinee to copy, into spaces below rows of numbers, the symbols that are paired to each number. The DSST score is the number of digits coded correctly in a 90-second test period
at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Time Frame: at baseline
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Time Frame: at 90 days post-randomization
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
at 90 days post-randomization
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Time Frame: at 12 months post-randomization
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
at 12 months post-randomization
Severity of Delirium
Time Frame: first 7 days post-randomization
The severity of delirium will be measured during daily screening using standardized algorithms for extracting symptom severity from the 3D-CAM and CAM-ICU.
first 7 days post-randomization
Number of Patients who experience Acute kidney injury (AKI)
Time Frame: within -7 days post-randomization
Number of Patients who experience Acute kidney injury will be assessed within 7 days post-randomization.
within -7 days post-randomization
All-cause mortality
Time Frame: within 90 days post-randomization
All-cause mortality within 90 days post-randomization will be assessed.
within 90 days post-randomization
All-cause mortality
Time Frame: within 12 months post-randomization
All-cause mortality within 12-months post-randomization will be assessed.
within 12 months post-randomization
Length of Index Hospitalization
Time Frame: at hospital discharge, up to 30 days
Overall length of stay for the index hospitalization post-randomization will be measured and broken down by days spent in the ICU versus days not in the ICU.
at hospital discharge, up to 30 days
Discharge disposition
Time Frame: at hospital discharge, up to 30 days
Discharge disposition
at hospital discharge, up to 30 days
Readmissions rates
Time Frame: first 90 days
Readmission rates will be calculated for the first 90 days following randomization. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
first 90 days
Readmissions rates
Time Frame: up to 1 year post-randomization
Readmission rates will be calculated for the duration of follow-up, out to 1 year. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
up to 1 year post-randomization
Days Alive out of Hospital
Time Frame: within 90 days post-randomization
Days alive out of hospital and nursing/rehab facilities within 90 days after randomization
within 90 days post-randomization
Incidence of Delirium
Time Frame: first 7 days post-randomization

The incidence of delirium will be assessed daily by the Confusion Assessment Method (3D-CAM or CAM-ICU) scale, or by the presence of a delirium adverse event, during the first 7 days post-randomization.

The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4 and involves the presence/absence of delirium, but not its severity. Any error or behavioral observation consistent with a delirium feature means that feature is present.
first 7 days post-randomization
Duration of Delirium
Time Frame: first 7 days post-randomization

The duration of delirium will be measured as the number of days with positive CAM assessments or delirium adverse events by 7 days post-randomization.

The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
first 7 days post-randomization
Actigraphy
Time Frame: 7-day period prior to index surgical procedure and Day 1 post index surgical procedure through hospital discharge

Actigraphy data will be collected for a period of 7 days prior to the index surgical procedure. Actigraphic monitoring employs an accelerometer the size of a watch, which each study patient will wear on the wrist.

Collected for participants in substudy.
7-day period prior to index surgical procedure and Day 1 post index surgical procedure through hospital discharge
Amount of Circadian Light
Time Frame: 7-day period prior to index surgical procedure

A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to monitor the total amount of circadian light received by the patient.

Collected for participants in substudy.
7-day period prior to index surgical procedure
Photopic Light Levels
Time Frame: 7-day period prior to index surgical procedure

A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to calculate photopic light levels

Collected for participants in substudy.
7-day period prior to index surgical procedure
Circadian Stimulus Values
Time Frame: 7-day period prior to index surgical procedure

A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to calculate circadian stimulus values,

Collected for participants in substudy.
7-day period prior to index surgical procedure
Richards-Campbell Sleep Questionnaire
Time Frame: Day 1 post index surgical procedure through patient discharge from the ICU (average ICU stay is 3 days)

Patients who are able to do so will be asked to fill out the Richards-Campbell Sleep Questionnaire (RCSQ), which is a brief 2-minute questionnaire designed for patient use in the ICU. Full score range from 0-100, with higher score indicating better sleep.

Collected for participants in substudy.
Day 1 post index surgical procedure through patient discharge from the ICU (average ICU stay is 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Annetine C. Gelijns, PhD, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Steve Messe, MD, University of Pennsylvania
  • Principal Investigator: Alexander Iribarne, MD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-23-00417
  • 5U01HL088942-16 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.

IPD Sharing Access Criteria

Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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