Plaque Burden Pre- Myocardial Revascularisation (ByPlaque)

October 18, 2023 updated by: Medical University Innsbruck

Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation

The study is a prospective-observational, explorative single-centre cohort study aimed to examine the influence of the peripheral atherosclerotic plaque volume on short and long term morbidity and mortality in patient after coronary artery bypass grafting (CABG).

Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the internal thoracic arteries will be evaluated additionally with US. These parameters will be measured pre-CABG.

Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

252

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 Backup

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University of Innsbruck

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

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients, who are are listed for elective CABG at the Medical University Innsbruck will be screened and recruited.

Description

Inclusion Criteria:

  • pre CABG

Exclusion Criteria:

  • no consent, prior carotid intervention

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

Outcome Measure
Measure Description
Time Frame
Association of MACE rates with peripheral atherosclerotic volume
Time Frame: 5 years
5 years
Association of morbidity with peripheral atherosclerotic volume
Time Frame: 5 years
Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions
Time Frame: 1 year
Risk scores include STS Score and Euro Score
1 year
Association of the duration of the operation with peripheral atherosclerotic volume
Time Frame: 30 days
30 days
Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates
Time Frame: 5 years
5 years
Association of the aortic clamp time with peripheral atherosclerotic volume
Time Frame: 30 days
30 days
Association of the ICU stay with peripheral atherosclerotic volume
Time Frame: 30 days
30 days
Association of the hospitalization duration with peripheral atherosclerotic volume
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Peter Marschang, MD, Medical University Innsbruck

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)

September 1, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1098/2017

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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