Plaque Burden Pre- Myocardial Revascularisation

Atherosclerosis Clinical Trial

— ByPlaque  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774004
• Other study ID #: 1098/2017
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2023
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: July 1, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• pre CABG

Exclusion Criteria:

• no consent, prior carotid intervention

Related Conditions & MeSH terms

• Atherosclerosis

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of MACE rates with peripheral atherosclerotic volume		5 years
Primary	Association of morbidity with peripheral atherosclerotic volume	Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"	5 years
Secondary	Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions	Risk scores include STS Score and Euro Score	1 year
Secondary	Association of the duration of the operation with peripheral atherosclerotic volume		30 days
Secondary	Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates		5 years
Secondary	Association of the aortic clamp time with peripheral atherosclerotic volume		30 days
Secondary	Association of the ICU stay with peripheral atherosclerotic volume		30 days
Secondary	Association of the hospitalization duration with peripheral atherosclerotic volume		30 days