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

NCT05453097 | Unknown DMC

• 1 other identifier: 2022/172
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Ischemia; Cardiac Arrhythmia; Perioperative Injury; Perioperative Complication

Keywords

myocardial injury; Perioperative injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility.

  Arrhythmia surveillance during peroperative and postoperative 1st hour in PACU

• 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

  postoperative intensive care hospitalizations for cardiac reasons until postoperative 24 hours

Study Arms (2)

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

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

Interventions

Selvester QRS Score with Preoperative ECG DIAGNOSTIC_TEST

Selvester QRS score will be calculated with the preoperative ECG of the patients.

Perioperative Myocardial Injury Not Occured; Perioperative Myocardial Injury Occured

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Related 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.jelectrocard.2011.06.008.

  PMID: 21872001 RESULT

• 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.

  PMID: 34246860 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cardiac Troponin and routine biochemical analysis

MeSH Terms

Conditions

Coronary Artery Disease; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kivanc Yalin, MD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 12, 2022
• Study Start: August 11, 2022
• Primary Completion: September 26, 2023
• Study Completion: November 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)