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

Active, not recruiting

• Conditions: Cardiac Ischemia; Perioperative Injury; Perioperative Complication; Cardiac Arrhythmia
• Interventions: Diagnostic Test: Selvester QRS Score with Preoperative ECG

• Registration Number: NCT05453097
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

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 Timeline

• Study First Submitted: 2022-06-26
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-12
• Study Start: 2022-08-11
• Status Verified: 2023-09
• Primary Completion: 2023-09-26
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Perioperative Myocardial Injury Occured	Selvester QRS Score with Preoperative ECG	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.
Perioperative Myocardial Injury Not Occured	Selvester QRS Score with Preoperative ECG	Patients without troponin elevation from the preoperative basal level, do not describe active anginal complaints, and underwent surgery in the operating room.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Fatih, Turkey