Evaluation of a Model for Post-Anesthesia Troponin Increase and Heart Injury EStimation (EMPATHIES)

January 17, 2020 updated by: Riccardo Colombo, ASST Fatebenefratelli Sacco

Evaluation of a Model for Post-anesthesia Troponin Increase and Heart Injury Estimation

This study evaluates the preoperative cardiovascular risk, the intraoperative hemodynamic characteristics and the surgical photo-plethysmographic index of patients undergoing general anesthesia for non-cardiac vascular surgery to develop a multiple variable model assessing the risk for postoperative myocardial ischemic events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Perioperative cardiac troponin leak is common and is strongly associated with mortality even in absence of classic myocardial infarction signs. In the VISION study 11.6% of patients undergoing non-cardiac surgery were troponin positive and 1.9% (95%CI 1.7-2.1%) of those patients died within 30 days of surgery. In selected populations of patients undergoing vascular surgery, a postoperative cTn leak, without clinical features of myocardial ischemia, is associated with an increased risk of 30-day mortality (odds ratio 5.03, 95% CI 2.88-8.79). Myocardial oxygen supply-demand imbalance and plaque rupture/thrombosis are the main mechanism involved in the pathogenesis of postoperative myocardial ischemic events. Frequently cardiac troponin leaks occur in absence of classical signs and symptoms of myocardial infarction. More than 80% of patients with postoperative cardiac troponin leak are clinically asymptomatic for myocardial ischemia, and ischemic ECG changes are often absent.

The identification of patients who will experience a postoperative myocardial ischemia will continue to be a challenge for anaesthesiologists.The current tool used for risk stratification using the AHA/ACC algorithm is Lee's Revised Cardiac Risk Index. Unfortunately, this tool can only reliably exclude low-risk patients and cannot identify patients which are likely to have perioperative cardiovascular complications.

The surgical plethysmographic index (SPI, GE Healthcare, Finland) during general anaesthesia has been correlated with the stressors of surgery (e.g. intubation, incision, …), and with stress hormone production. It has been demonstrated that SPI and other pulse photo-plethysmographic indices reflect sympathetic-mediated vasoconstriction, thus monitoring the SPI during general anesthesia could lead to a reduced sympathetic response to surgical stimuli. Unfortunately there is not a desirable level of SPI, and it is unknown if difference in SPI values during the surgery might affect the postoperative outcome.

Intraoperative hemodynamic parameters and SPI will be recorded in conjunction with preoperative cardiovascular risk scores and will be used to develop a multiple variable model for postoperative risk of myocardial ischemic events.

In this study Electrocardiogram, invasive arterial pressure, photoplethysmography,and electroencephalographic entropy will be collected continuously from 10 min before induction of general anesthesia until 20 min after awakening from anesthesia. Gupta's score and Revised Cardiac Risk Index will be recorded the day before surgery.

Blood samples for high sensitive cardiac troponin T (hs-TnT) assay will be collected on day of surgery (baseline) and on postoperative day 1, 2 and 3. According to this methodology, in this study postoperative myocardial ischemic events will be defined as:

  1. Myocardial Infarction according to the third universal definition (Thygesen K. et al. Third universal definition of myocardial infarction. Circulation 2012;126:2020-35 )
  2. Myocardial Injury defined a hs-TnT plasmatic concentration of (i) 20-65 ng/L with an increase >5ng/L between baseline to days 1-3, or (ii) >65 ng/L, or (iii) a rise >50% between baseline and days 1-3 in case of renal insufficiency, all of them in absence of non-ischemic causes of troponin increase (sepsis, pulmonary embolism, electrical cardioversion and acute respiratory failure).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Contacts and Locations

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

Study Locations

  • Italy
      • Milan, Italy, 20157
        • ASST Fatebenefratelli Sacco, Luigi Sacco Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing general anesthesia for elective non-cardiac vascular surgery

Description

Inclusion Criteria:

  • patients scheduled for elective non-cardiac vascular surgery under general anesthesia

Exclusion Criteria:

  • Raynaud's phemomenon
  • permanent atrial fibrillation or non sinus rhythm on ECG or ectopic beats >5% of normal sinus beats
  • implanted with pacemaker
  • any circulation problem in forefingers
  • scheduled for postoperative ICU admission
  • a new therapy with beta-blockers started <7 days before the surgery

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Vascular surgical patients
Patients undergoing elective vascular non-cardiac surgery in general anesthesia
Diagnostic test: collection of cardiovascular risk scores and intraoperative cardiovascular parameters
collection of preoperative cardiovascular risk scores and intraoperative cardiovascular parameters
Diagnostic test: cardiac troponin assay
plasmatic concentration of high sensitive cardiac troponin will be measured at baseline and on postoperative day 1, 2 and 3
Diagnostic test: Electrocardiogram
12 derivations ECG will be made at baseline and on postoperative day 1, 2, and 3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prediction of Postoperative Myocardial Ischemia
Time Frame: 72 hours after the surgery
Cox's proportional model of preoperative cardiovascular risk scores and physiologic intraoperative variables for prediction of the occurrence of Postoperative Myocardial Ischemia
72 hours after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
prediction of postoperative myocardial ischemic events or stroke
Time Frame: 30 days
Cox's proportional model of preoperative cardiovascular risk scores and physiologic intraoperative variables for prediction of postoperative myocardial ischemic events or stroke
30 days
mortality
Time Frame: 30 and 90 days
measured by clinical record review and phone interview
30 and 90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ASST Fatebenefratelli Sacco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tommaso Fossali
Beatrice Borghi
Emanuele Catena
Andrea Perotti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PMI_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

de-identified patients' data will be available to other researchers

IPD Sharing Time Frame

after the publication of the study results

IPD Sharing Access Criteria

researchers that have been approved by the principal investigator and by Ethical Committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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