NCT05800093
Active, not recruiting
Not Applicable
Proteomics and Genomics Combined With CT to Predict CVD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country310 target enrollmentJanuary 12, 2023
ConditionsCoronary Artery Disease Progression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease Progression
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 310
- Locations
- 1
- Primary Endpoint
- Coronary Artery Disease Progression
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.
Investigators
E.S.stroes
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
Inclusion Criteria
- •Adult patients between 50 and 75 years old
- •Subjects at intermediate to high risk for ASCVD
- •Asymptomatic patients without cardiac chest pain
- •Evidence of atherosclerosis on baseline CCTA
Exclusion Criteria
- •Renal insufficiency, defined as eGFR \< 30 ml/min
- •History of cardiovascular events (myocardial infarction, peripheral artery disease and ischemic stroke)
- •Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid monotherapy
- •Change in lipid lowering therapy in the last 6 months
- •Use of more than two antihypertensive agents
- •No coronary atherosclerosis at baseline imaging
- •Active malignancy requiring treatment
- •Atrial fibrillation
- •Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- •Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Outcomes
Primary Outcomes
Coronary Artery Disease Progression
Time Frame: Through study completion, between 130-156 weeks
Secondary Outcomes
- Presence of obstructive stenosis(Through study completion, between 130-156 weeks)
- Calcified plaque volume progression(Through study completion, between 130-156 weeks)
- Change in Pericoronary Adipose Tissue CT-Attenuation(Through study completion, between 130-156 weeks)
- Non-calcified plaque volume progression(Through study completion, between 130-156 weeks)
- Progression in number of high-risk plaque characteristics (yes/no)(Through study completion, between 130-156 weeks)
- Progression in number of significant (>50%) and severe (>70%) stenoses(Through study completion, between 130-156 weeks)
- Total plaque volume progression(Through study completion, between 130-156 weeks)
- Low-attenuation plaque volume progression(Through study completion, between 130-156 weeks)
- CAD-RADS progression (yes/no)(Through study completion, between 130-156 weeks)
Study Sites (1)
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