Clinical trial NCT05453097: Prognostic Value of the Selvester QRS Score for Perioperative Myocardial Injury Following Non-cardiac Surgery
Official title: Prognostic Value of the Selvester QRS Score for Perioperative Myocardial Injury Following Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Ischemia
Cardiac Arrhythmia
Perioperative Injury
Perioperative Complication
Keywords: myocardial injury
Perioperative injury
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prediction of perioperative cardiac injury with preoperative Selvester ECG Score
timeFrame: Change from Baseline cardiac troponin levels at postoperative 1st hour in PACU
Secondary outcomes:
measure: The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility.
timeFrame: Arrhythmia surveillance during peroperative and postoperative 1st hour in PACU
measure: Effect of preoperative cardiac assessment on postoperative cardiac adverse event
timeFrame: Cardiac adverse event surveillance during peroperative and postoperative 24 hours
measure: Determination of postoperative intensive care hospitalizations for cardiac reasons
timeFrame: postoperative intensive care hospitalizations for cardiac reasons until postoperative 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Fatih
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Kivanc Yalin, MD
role: STUDY_CHAIR
References:
citation: 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.
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.