Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization

February 24, 2025 updated by: University Hospital, Basel, Switzerland
This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

The early diagnosis of the periprocedural myocardial infarction (MI) due to the bypass graft occlusion is an important element, in order to introduce early therapeutic strategies. Invasive coronary angiography (CA) is the gold standard to evaluate the postoperative myocardial ischemia due to the graft occlusion. Since this procedure has several important risks, such as thromboembolic events, dissection, bleeding, and contrast dye-induced nephropathy, in daily clinical practice, only patients with strong clinical suspicion of early MI following coronary artery bypass grafting (CABG) undergo this invasive procedure. There is a clinical need for the development of safe and accurate non-invasive diagnostic approaches to assess the early coronary bypass graft occlusion and to predict the consequent MI. A new clinical approach for the identification of the early post-procedural graft occlusion in patients undergoing CABG surgery is the high-sensitivity cardiac troponin (hs-cTn) cut-off level. The peri-operative bypass occlusion will be assessed by a Coronary Computed Tomography (CCT) scan which is a widely available non-invasive approach that permits an accurate evaluation of coronary stenosis. This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

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.
480

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 Locations

  • Croatia
      • Zagreb, Croatia, 10 000
        • Not yet recruiting
        • University hospital centre Zagreb
        • Contact:
  • Poland
    • Borowska
      • Breslau, Borowska, Poland, 213
        • Not yet recruiting
        • Wroclaw Medical University
        • Contact:
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Department for Cardiac Surgery, University Hospital Basel
        • Contact:

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients who will undergo isolated coronary bypass surgery at the University Hospital Basel.

Description

Inclusion Criteria:

  • patients with isolated coronary bypass surgery

Exclusion Criteria:

  • Patients withholding or lacking informed consent
  • Patients requiring a concomitant procedure
  • Exclusion criteria concerning the CCT scan
  • Patients with known allergy to iodine-containing contrast agents
  • Renal function impairment (serum creatinine >140 mmol/l; estimated glomerular filtration rate (GFR) <30 ml/min/1.73 m2).
  • Pregnancy
  • Unstable clinical state or severe heart failure
  • Patients with registered MI and registered bypass occlusion in coronary angiogram
  • Patients that didn't undergo a CCT prior to discharge

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

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
Change in hs-cTn level (ng/L)
Time Frame: Day 0 to discharge date (max 10 days)
hs-cTn level following CABG to correlate between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT
Day 0 to discharge date (max 10 days)

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
All-cause mortality during hospital stay (death before discharge)
Time Frame: Day 0 to discharge date (max 10 days)
All-cause mortality during hospital stay (death before discharge)
Day 0 to discharge date (max 10 days)
Cardiac-related mortality during hospital stay
Time Frame: Day 0 to discharge date (max 10 days)
Cardiac-related mortality during hospital stay
Day 0 to discharge date (max 10 days)
Myocardial infarction during hospital stay
Time Frame: Day 0 to discharge date (max 10 days)
Myocardial infarction during hospital stay
Day 0 to discharge date (max 10 days)
Surgical or percutaneous coronary re-intervention during hospital stay
Time Frame: Day 0 to discharge date (max 10 days)
Surgical or percutaneous coronary re-intervention during hospital stay
Day 0 to discharge date (max 10 days)
Stroke rate during hospital stay
Time Frame: Day 0 to discharge date (max 10 days)
Stroke rate during hospital stay
Day 0 to discharge date (max 10 days)
Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay
Time Frame: Day 0 to discharge date (max 10 days)
Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay. MACCE is defined as a combined event of in-hospital mortality, stroke and myocardial infarction.
Day 0 to discharge date (max 10 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between intraoperative flow measurements and incidence of early bypass occlusion
Time Frame: Day 0 to discharge date (max 10 days)
Correlation between intraoperative flow measurements and incidence of early bypass occlusion
Day 0 to discharge date (max 10 days)
Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period
Time Frame: Day 0 to discharge date (max 10 days)
Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period
Day 0 to discharge date (max 10 days)
All-cause mortality
Time Frame: During one-year and 36 months follow up
All-cause mortality
During one-year and 36 months follow up
Cardiac-related mortality
Time Frame: During one-year and 36 months follow up
Cardiac-related mortality
During one-year and 36 months follow up
Myocardial infarction
Time Frame: During one-year and 36 months follow up
Myocardial infarction
During one-year and 36 months follow up
Stroke
Time Frame: During one-year and 36 months follow up
Stroke
During one-year and 36 months follow up
Congestive heart failure requiring hospitalization
Time Frame: During one-year and 36 months follow up
Congestive heart failure requiring hospitalization
During one-year and 36 months follow up
Surgical or percutaneous coronary intervention
Time Frame: During one-year and 36 months follow up
Surgical or percutaneous coronary intervention
During one-year and 36 months follow up
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: During one-year and 36 months follow up
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
During one-year and 36 months follow up

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.
University Hospital, Basel, Switzerland

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.
  • Principal Investigator: Denis Berdajs, Prof. Dr. med., Department of Cardiac Surgery, University Hospital Basel

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.
July 1, 2021

Primary Completion (Estimated)

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.
December 1, 2029

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.
December 1, 2029

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).
October 6, 2020

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.
October 14, 2020

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.
October 20, 2020

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.
March 25, 2025

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.
February 24, 2025

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.
February 1, 2025

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.
  • 2020-02257; ch20Berdajs

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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