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OpenTrials
Completed

NCT Number: NCT03774004

Plaque Burden Pre- Myocardial Revascularisation

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pre CABG

Exclusion criteria

  • no consent, prior carotid intervention

Treatment and study plan

Primary outcomes

  1. Association of MACE rates with peripheral atherosclerotic volume

    Time frame: 5 years

  2. Association of morbidity with peripheral atherosclerotic volume

    Time frame: 5 years

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

Secondary outcomes

  1. 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

  2. Association of the duration of the operation with peripheral atherosclerotic volume

    Time frame: 30 days

  3. Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates

    Time frame: 5 years

  4. Association of the aortic clamp time with peripheral atherosclerotic volume

    Time frame: 30 days

  5. Association of the ICU stay with peripheral atherosclerotic volume

    Time frame: 30 days

  6. Association of the hospitalization duration with peripheral atherosclerotic volume

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: ByPlaque

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 12, 2018
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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