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NCT05352386 Clinical Trial

Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

Familial Hypercholesterolemia Clinical Trial

— CHEETAH  

Official title:
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05352386
Other study ID # NL79640.018.21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2022
Est. completion date December 19, 2022

Study information
Verified date March 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date December 19, 2022
Est. primary completion date December 19, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria: - Diagnosed with heterozygous familial hypercholesterolemia or non FH-control - Adult patients between 25 and 55 years old. Exclusion Criteria: - Renal insufficiency, defined as eGFR < 30 ml/min - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Coronary computed tomography angiography (CCTA)
Participants undergo coronary computed tomography angiography (CCTA)

Locations
Country Name City State
Netherlands Amsterdam UMC, location AMC Amsterdam

Sponsors (2)
Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total coronary plaque volume (mm3) Day 0
Primary Total coronary plaque burden (%) Day 0
Secondary Presence of >50% obstructive stenosis per vessel Day 0
Secondary Presence of <50% nonobstructive stenosis per vessel Day 0
Secondary Calcified coronary plaque volume (mm^3) Day 0
Secondary Calcified coronary plaque burden (%) Day 0
Secondary Non-calcified plaque volume (mm^3) Day 0
Secondary Non-calcified plaque burden (%) Day 0
Secondary Low attenuation plaque volume (mm^3) Day 0
Secondary Low attenuation plaque burden (%) Day 0
Secondary Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign) Day 0
Secondary Pericoronary adipose tissue attenuation (Hounsfield units) Day 0
Secondary Plasma LDL cholesterol (mmol/l) Day 0
Secondary Plasma apolipoprotein B (g/l) Day 0
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