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Clinical Trials/NCT03774004
NCT03774004
Completed
Not Applicable

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

Medical University Innsbruck1 site in 1 country252 target enrollmentSeptember 1, 2018
ConditionsAtherosclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerosis
Sponsor
Medical University Innsbruck
Enrollment
252
Locations
1
Primary Endpoint
Association of morbidity with peripheral atherosclerotic volume
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
July 1, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University Innsbruck
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • no consent, prior carotid intervention

Outcomes

Primary Outcomes

Association of morbidity with peripheral atherosclerotic volume

Time Frame: 5 years

Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"

Association of MACE rates with peripheral atherosclerotic volume

Time Frame: 5 years

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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