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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05453097
• Other study ID #: 2022/172
• Status: Active, not recruiting
• Start date: August 11, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: November 30, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiac Ischemia
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Perioperative Complication
• Wounds and Injuries

Intervention

Diagnostic Test:
• Selvester QRS Score with Preoperative ECG
Selvester QRS score will be calculated with the preoperative ECG of the patients.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Loring Z, Chelliah S, Selvester RH, Wagner G, Strauss DG. A detailed guide for quantification of myocardial scar with the Selvester QRS score in the presence of electrocardiogram confounders. J Electrocardiol. 2011 Sep-Oct;44(5):544-54. doi: 10.1016/j.jel — View Citation

Sapra R, Hallqvist L, Schlegel TT, Ugander M, Bell M, Maanja M. Predicting peri-operative troponin elevation by advanced electrocardiography. J Electrocardiol. 2021 Sep-Oct;68:1-5. doi: 10.1016/j.jelectrocard.2021.06.008. Epub 2021 Jul 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prediction of perioperative cardiac injury with preoperative Selvester ECG Score	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	The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility.	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
Secondary	Effect of preoperative cardiac assessment on postoperative cardiac adverse event	Effect of preoperative cardiac assessment on postoperative cardiac adverse event	Cardiac adverse event surveillance during peroperative and postoperative 24 hours
Secondary	Determination of postoperative intensive care hospitalizations for cardiac reasons	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