Plaque Burden Pre- Myocardial Revascularisation
ByPlaque
Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation
1 other identifier
observational
252
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedOctober 23, 2023
October 1, 2023
2.3 years
December 11, 2018
October 18, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Association of MACE rates with peripheral atherosclerotic volume
5 years
Association of morbidity with peripheral atherosclerotic volume
Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"
5 years
Secondary Outcomes (6)
Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions
1 year
Association of the duration of the operation with peripheral atherosclerotic volume
30 days
Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates
5 years
Association of the aortic clamp time with peripheral atherosclerotic volume
30 days
Association of the ICU stay with peripheral atherosclerotic volume
30 days
- +1 more secondary outcomes
Eligibility Criteria
Patients, who are are listed for elective CABG at the Medical University Innsbruck will be screened and recruited.
You may qualify if:
- pre CABG
You may not qualify if:
- no consent, prior carotid intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Innsbruck
Innsbruck, Tyrol, 6020, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Marschang, MD
Medical University Innsbruck
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 12, 2018
Study Start
September 1, 2018
Primary Completion
December 31, 2020
Study Completion
July 1, 2021
Last Updated
October 23, 2023
Record last verified: 2023-10