Prognostic Value of the Selvester QRS Score for Perioperative Myocardial Injury Following Non-cardiac Surgery

September 26, 2023 updated by: Deniz Mutlu, Istanbul University - Cerrahpasa (IUC)
The purpose of this study to determine the prognostic value of the Selvester QRS score for perioperative myocardial injury following elective non-cardiac surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was designed as an investigator-directed, non-commercial, observational, prospective, national, single-center study. The effect of preoperative complex ECG changes on the formation of cardiac damage will be studied. The data of the people participating in the study will be kept entirely confidential. After being informed about the study, all patients giving written informed consent will undergo preoperative evaluation. An ECG and cardiac troponin analysis will be performed to the patients who meet the eligibility. After the surgery will be completed control cardiac troponin and extensive physical examination will be performed.

Study Type

Observational

Enrollment (Estimated)

400

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

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34098
        • Istanbul University-Cerrahpasa

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will be conducted on patients aged 18-90 years who have had elective surgery (besides cardiac operations) performed by a surgeon in the operating rooms of a tertiary university hospital, whose ECG before the operation is interpretable, and whose troponin value is measured before and after the operation.

Description

Inclusion Criteria:

  • Patients who undergoing elective non-cardiac surgery in the operating room
  • ≥18 years old
  • Interpretable preoperative ECG of the patient
  • Preoperative negative high sensitive Cardiac Troponin T
  • ASA I-III class
  • Patients who give the informed consent

Exclusion Criteria:

  • A history of myocardial infarction, coronary artery disease, PCI and revascularization
  • A history of chronic renal disease, cerebrovascular incident, stroke
  • ASA class IV
  • Patients who do not give the informed consent
  • Patients who undergoing emergency surgery
  • Patients whose preoperative ECG is not interpretable
  • Minor procedures to be performed outside or inside the operating room

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Perioperative Myocardial Injury Occured
Patients with troponin elevation from the preoperative basal level do not meet the criteria for myocardial infarction according to the fourth universal myocardial infarction guideline, do not describe active anginal complaints, and underwent surgery in the operating room.
Diagnostic test: Selvester QRS Score with Preoperative ECG
Selvester QRS score will be calculated with the preoperative ECG of the patients.
Perioperative Myocardial Injury Not Occured
Patients without troponin elevation from the preoperative basal level, do not describe active anginal complaints, and underwent surgery in the operating room.
Diagnostic test: Selvester QRS Score with Preoperative ECG
Selvester QRS score will be calculated with the preoperative ECG of the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prediction of perioperative cardiac injury with preoperative Selvester ECG Score
Time Frame: Change from Baseline cardiac troponin levels at postoperative 1st hour in PACU
Selvester ECG score is a validated technique for predicting myocardial scar and injury level in patients who undergone PCI. It is aimed to predict and demonstrate perioperative myocardial damage using this algorithm.
Change from Baseline cardiac troponin levels at postoperative 1st hour in PACU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility.
Time Frame: Arrhythmia surveillance during peroperative and postoperative 1st hour in PACU
The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility by monitoring the cardiac rhythm
Arrhythmia surveillance during peroperative and postoperative 1st hour in PACU
Effect of preoperative cardiac assessment on postoperative cardiac adverse event
Time Frame: Cardiac adverse event surveillance during peroperative and postoperative 24 hours
Effect of preoperative cardiac assessment on postoperative cardiac adverse event
Cardiac adverse event surveillance during peroperative and postoperative 24 hours
Determination of postoperative intensive care hospitalizations for cardiac reasons
Time Frame: postoperative intensive care hospitalizations for cardiac reasons until postoperative 24 hours
Determination of the reasons of the postoperative intensive care unit hospitalizations for cardiac reasons.
postoperative intensive care hospitalizations for cardiac reasons until postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Chair: Kivanc Yalin, MD, Istanbul University - Cerrahpasa (IUC)

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)

August 11, 2022

Primary Completion (Actual)

September 26, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/172 (Other Identifier: University of gaziantep clinical research ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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