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EAGLE: Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05783804
Collaborator
(none)
60
Enrollment
1
Location
32.8
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
    Actual Study Start Date :
    Jul 7, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. CAD Progression [40 Weeks]

      Difference in total plaque volume between the initial and follow-up CCTA scan

    Secondary Outcome Measures

    1. Non-calcified plaque progression [40 Weeks]

      Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan

    2. Calcified plaque progression [40 Weeks]

      Difference in calcified plaque volume between the baseline and follow-up CCTA scan

    3. Number of high-risk plaques [40 Weeks]

      Difference in number of high-risk plaques between the baseline and follow-up CCTA scan

    4. Difference in Pericoronary Adipose Tissue Attenuation [40 Weeks]

      Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Amsterdam UMC, location AMC Amsterdam Noord-Holland Netherlands 1105 AZ

    Sponsors and Collaborators

    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Investigators

    • Principal Investigator: Erik SG Stroes, MD, PhD, Amsterdam UMC, location AMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    E.S.stroes, Prof. dr. E.S.G. Stroes, MD, PhD., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT05783804
    Other Study ID Numbers:
    • NL75337.018.20
    First Posted:
    Mar 24, 2023
    Last Update Posted:
    Mar 24, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Disease Progression

    Study Results

    No Results Posted as of Mar 24, 2023