- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04543838
IMMPRES: Intraoperative Monitoring & Management to Reduce Stroke
Intraoperative Monitoring and Management Protocol to Reduce Strokes (IMMPRES): Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
If the patient is eligible, interested, and provides consent, they will complete initial preoperative baseline surveys and assessments. These assessments include: Medical History, Medications, Neurological Exam, NIH stroke Scale, Questionnaire for Verifying Stroke-Free Status (QVSFS), Delirium Screen, Modified Rankin Scale, Barthel Index, Cognitive Assessment: The Montreal Cognitive Assessment (MoCA), Depression Scale, and Quality of Life scale. General history, risk factor profile and physical examination (H&P) will be performed prior to entering the study. Neurological examinations, NIHSS, Modified Rankin Scale and Barthel Index will be performed by study neurologist. A Questionnaire for Verifying Stroke-Free Status (revised Questionnaire for Verifying Stroke-Free Status (QVSFS)), QOL assessment, Delirium and Cognitive assessment will be administered to each potentially eligible patient by a research coordinator. Subjects of child bearing age will complete a pregnancy test.
Baseline surveys and assessments will collected during a pre-operative session, either in conjunction with a pre-op clinic visit in-person prior to surgery during their surgical admission. This will allow maximum flexibility in timing, without interfering with clinical care.
Clinically collected data will be abstracted from the electronic medical record (EMR) for research purposes. We will review the patients preoperative medical records to screen patients for the use of intraoperative monitoring. This is currently a standard clinical practice. After enrollment, the subject will be randomized into the control or intervention group. Subjects will be computer randomized to condition 1:1. It will take approximately a half an hour to complete surveys and study procedures. On the day of surgery, EEG and somatosensory evoked potentials assessments will be performed preoperatively.
Procedure: The cardiac surgeons who will be performing surgery will be informed by the principal investigator. The medical management of patients before, during, and after the procedure will be continued as routine medical care in standard medical therapy group. In the intervention group, standard medical therapy with intraoperative monitoring and management protocol will be done. Our IMMP will be a) intraoperative monitoring with SSEP and EEG during surgery and continued for 4 hours after; b) management protocol will be treating patients based on a SSEP and/or EEG changes. In patients with bilateral SSEP and/or EEG changes, we will aim for a MAP target of the greater of 20% above the patient's preoperative baseline or an absolute threshold of 80 mmHg. In patients with persistent unilateral SSEP and/or EEG changes, the higher MAP target will be maintained followed by immediate post-operative evaluation for stroke.
In the control group, the patient will receive standard of care.
Post-Procedure/Pre-Discharge: Brief history and physical examination daily while patient is in hospital. Neurological examination performed by study Neurologist. Delirium screen will be performed. NIH Stroke Scale (NIHSS) performed by study neurologist 18 to 54 hours post procedure. MRI will be performed before discharge. The MRI will be completed at the MRI Research Center.The Cognitive Assessment: The Montreal Cognitive Assessment (MoCA) will be performed.
Follow-up: At 30 days post-op: Modified Rankin Scale, Barthel Index, Questionnaire for Verifying Stroke-Free Status (QVSFS), Quality of Life Assessment, and Cognitive Assessment: The Montreal Cognitive Assessment (MoCA) will be performed.
Follow-up: At 1 year: Neurological exam, Modified Rankin Scale, Barthel Index, TIA/Stroke Questionnaire, Quality of Life Assessment and cognitive evaluation will be performed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melanie Driscoll, BS
- Phone Number: 412-623-1914
- Email: driscollms2@upmc.edu
Study Contact Backup
- Name: Amy Monroe, MBA, MPH
- Phone Number: 412-623-6382
- Email: Monroeal@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients scheduled for Cardiac surgery at UPMC
- Patients who are 18 years of age or older at screening
- Patients with the ability to provide written informed consent
Exclusion Criteria:
- Patient who, as determined by the investigators, are noncompliant or unable to complete follow-up assessments
- Patient with history of dementia or other cognitive impairment. History of dementia will be determined by medical record review.
- Patients who, as determined by the investigators, are unable to complete the preoperative testing
- Have an implanted medical electronic device
- Have indwelling or implanted metal in their body that is not MRI-compatible
- Have claustrophobia. This will be measured by utilizing the standard screening questionnaire for MRI.
- Develop back pain when lying flat for more than 1 hour
- Pregnancy
Study Plan
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 |
---|---|
Experimental: EEG & SSEP monitoring
Intervention will include standard of care pain management during the postoperative period.
Participants in this arm will receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP).
EEG will be used to manage blood pressure.
|
Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring
|
Active Comparator: Standard of Care
Control will include standard of care pain management during the postoperative period.
Participants in this arm will not receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP).
|
If blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with a new clinical stroke, new overt stroke, and death
Time Frame: post-operative day 30
|
Proportion of patients with a new clinical stroke, new overt stroke, and death will be abstracted from subject EMR.
|
post-operative day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with cognitive decline
Time Frame: post-operative 1 year
|
Proportion of patients with cognitive decline will be assessed by observing patients who score up to 2 points or more on the Montreal Cognitive Assessment
|
post-operative 1 year
|
Proportion of patients with transient ischemic attack
Time Frame: post-operative 1 year
|
Proportion of patients with transient ischemic attack will be abstracted from subject EMR.
|
post-operative 1 year
|
Proportion of patients with delirium
Time Frame: post-operative 1 year
|
Proportion of patients with delirium will be abstracted from subject EMR.
|
post-operative 1 year
|
Proportion of patients with clinical stroke
Time Frame: post-operative 1 year
|
Proportion of patients with clinical stroke will be abstracted from subject EMR.
|
post-operative 1 year
|
Proportion of patients with composite of clinical stroke
Time Frame: post-operative 1 year
|
Proportion of patients with composite of clinical stroke will be abstracted from subject EMR.
|
post-operative 1 year
|
Proportion of patients with MACE (death from any cause, non-fatal MI and stroke)
Time Frame: post-operative 1 year
|
Proportion of patients with MACE (death from any cause, non-fatal MI and stroke) will be abstracted from subject EMR.
|
post-operative 1 year
|
Proportion of patients with a decrease in quality of life
Time Frame: post-operative 1 year
|
Proportion of patients with a decrease in quality of life will be assessed by the EuroQol 5-dimension (EQ-5D).
The EQ-5D questionnaire consists of two parts.
The first part contains the EQ-5D descriptive system, comprising of 5 questions regarding mobility, selfcare, usual activities, pain, and depression (scores range from 0 to 1).
The second part is a vertical, visual analogue scale with the end-points of "best imaginable health state" and "worst imaginable health state" (scores range from 0 to 100).
A tool "EQ-5D-5L Crosswalk Index Value Calculator" calculates the crosswalk index values for the EQ-5D-5L dimension scores.
|
post-operative 1 year
|
Proportion of patients with a discrete diffusion-weighted imaging (DWI) lesion
Time Frame: post-operative 1 year
|
Proportion of patients with a discrete DWI lesion will be abstracted from subject EMR.
|
post-operative 1 year
|
Overall volume of DWI lesion burden
Time Frame: post-operative 1 year
|
Overall volume of DWI lesion burden will be abstracted from subject EMR.
|
post-operative 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith Vogt, MD, PhD, University of Pittsburgh
- Principal Investigator: Parthasarathy Thirumala, MD, MS, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20070328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Cardiac Surgery
-
Nationwide Children's HospitalCompleted
-
Universitätsklinikum Hamburg-EppendorfRecruitingSerratus Anterior Plane Block | Minimal Invasive Cardiac Surgery | Minimal Invasive Cardiac Surgery Mitral Valve SurgeryGermany
-
Shanghai Zhongshan HospitalRecruitingCardiac Surgery | Cardiac OutputChina
-
Sheba Medical CenterTerminatedDisorder; Heart, Functional, Postoperative, Cardiac Surgery | Heart; Dysfunction Postoperative, Cardiac SurgeryIsrael
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Population Health Research Institute and other collaboratorsActive, not recruitingSurgery (Cardiac) | Surgery (Major Vascular)Canada, United Kingdom
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Yan FuxiaNot yet recruitingCardiac Surgery | Enhanced Recovery After SurgeryChina
-
Yonsei UniversityCompletedCardiac Surgery | Vascular Surgery Using CPBKorea, Republic of
Clinical Trials on Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...American Cancer Society, Inc.Completed
-
Vanderbilt UniversityAgency for Healthcare Research and Quality (AHRQ)Completed