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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

ASST Fatebenefratelli Sacco

Collaborators

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)

April 2, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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