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

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05453097

Collaborator

(none)

400

Enrollment

Location

8.6

Anticipated Duration (Months)

46.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to determine the prognostic value of the Selvester QRS score for perioperative myocardial injury following elective non-cardiac surgery.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Ischemia Cardiac Arrhythmia Perioperative Injury Perioperative Complication	Diagnostic Test: Selvester QRS Score with Preoperative ECG

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 11, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

The prediction of perioperative cardiac injury with preoperative Selvester ECG Score [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.

Secondary Outcome Measures

The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility. [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
Effect of preoperative cardiac assessment on postoperative cardiac adverse event [Cardiac adverse event surveillance during peroperative and postoperative 24 hours]
Effect of preoperative cardiac assessment on postoperative cardiac adverse event
Determination of postoperative intensive care hospitalizations for cardiac reasons [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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