Plaque Burden Pre- Myocardial Revascularisation (ByPlaque)
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|ClinicalTrials.gov Identifier: NCT03774004|
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 14, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||July 1, 2021|
- Association of MACE rates with peripheral atherosclerotic volume [ Time Frame: 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"
- 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
- Association of the duration of the operation with peripheral atherosclerotic volume [ Time Frame: 30 days ]
- Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates [ Time Frame: 5 years ]
- Association of the aortic clamp time with peripheral atherosclerotic volume [ Time Frame: 30 days ]
- Association of the ICU stay with peripheral atherosclerotic volume [ Time Frame: 30 days ]
- Association of the hospitalization duration with peripheral atherosclerotic volume [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774004
|Contact: Michael Schreinlechner, MD||004351250481308||Michael.Schreinlechner@i-med.ac.at|
|Contact: Peter Marschang, MD||Peter.Marschang@i-med.ac.at|
|Medical University of Innsbruck||Recruiting|
|Innsbruck, Tyrol, Austria, 6020|
|Contact: Michael Schreinlechner, MD 004351250481308 Michael.Schreinlechner@i-med.ac.at|
|Principal Investigator:||Peter Marschang, MD||Medical University Innsbruck|