Plaque Burden Pre- Myocardial Revascularisation

Completed

• Conditions: Atherosclerosis

• Registration Number: NCT03774004
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• pre CABG

Exclusion Criteria

• no consent, prior carotid intervention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria