NCT05783804
Recruiting
Not Applicable
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country60 target enrollmentJuly 7, 2022
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
- 60
- Locations
- 1
- Primary Endpoint
- CAD Progression
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This study evaluates whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, intensive lipid lowering therapy.
Investigators
E.S.stroes
Prof. dr. E.S.G. Stroes, MD, PhD.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with heterozygous familial hypercholesterolemia
- •Adult between 18 and 50 years old
- •LDL cholesterol levels above 100 mg/dl (\>2.6 mmol/L) at inclusion
Exclusion Criteria
- •Renal insufficiency, defined as eGFR \< 30 ml/min
- •History of atherosclerotic cardiovascular events
- •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
CAD Progression
Time Frame: 40 Weeks
Difference in total plaque volume between the initial and follow-up CCTA scan
Secondary Outcomes
- Non-calcified plaque progression(40 Weeks)
- Calcified plaque progression(40 Weeks)
- Number of high-risk plaques(40 Weeks)
- Difference in Pericoronary Adipose Tissue Attenuation(40 Weeks)
Study Sites (1)
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