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

September 26, 2023 updated by: Deniz Mutlu, Istanbul University - Cerrahpasa (IUC)
The purpose of this study to determine the prognostic value of the Selvester QRS score for perioperative myocardial injury following elective non-cardiac surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ozgecan P Zanbak Mutlu, MD
  • Phone Number: 69000 +902124143000
  • Email: pirilz@hotmail.com

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34098
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The prediction of perioperative cardiac injury with preoperative Selvester ECG Score
Time Frame: 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.
Change from Baseline cardiac troponin levels at postoperative 1st hour in PACU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility.
Time Frame: 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
Arrhythmia surveillance during peroperative and postoperative 1st hour in PACU
Effect of preoperative cardiac assessment on postoperative cardiac adverse event
Time Frame: Cardiac adverse event surveillance during peroperative and postoperative 24 hours
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
Time Frame: 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.
postoperative intensive care hospitalizations for cardiac reasons until postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kivanc Yalin, MD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/172 (Other Identifier: University of gaziantep clinical research ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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