Plaque Burden Pre- Myocardial Revascularisation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03774004

Acronym

ByPlaque

Enrollment

252

Registered

2018-12-12

Start date

2018-09-01

Completion date

2021-07-01

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Inclusion criteria

* pre CABG

Exclusion criteria

* no consent, prior carotid intervention

Design outcomes

Primary

Measure	Time frame	Description
Association of MACE rates with peripheral atherosclerotic volume	5 years	—
Association of morbidity with peripheral atherosclerotic volume	5 years	Morbidity will be evaluated with quality of life assessment (EQ-5D-3L, IPAQ

Secondary

Measure	Time frame	Description
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	—
Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions	1 year	Risk scores include STS Score and Euro Score
Association of the hospitalization duration with peripheral atherosclerotic volume	30 days	—
Association of the ICU stay with peripheral atherosclerotic volume	30 days	—
Association of the duration of the operation with peripheral atherosclerotic volume	30 days	—

Countries

Austria

Outcome results