Back to resultsCoronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia (CHEETAH)
Primary Purpose
Familial Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Coronary computed tomography angiography (CCTA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Familial Hypercholesterolemia
Eligibility Criteria
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.
Sites / Locations
- Amsterdam UMC, location AMC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Patients with familial hypercholesterolemia, early treated
Patients without familial hypercholesterolemia, late treated
Healthy individuals
Arm Description
Outcomes
Primary Outcome Measures
Total coronary plaque volume (mm3)
Total coronary plaque burden (%)
Secondary Outcome Measures
Presence of >50% obstructive stenosis per vessel
Presence of <50% nonobstructive stenosis per vessel
Calcified coronary plaque volume (mm^3)
Calcified coronary plaque burden (%)
Non-calcified plaque volume (mm^3)
Non-calcified plaque burden (%)
Low attenuation plaque volume (mm^3)
Low attenuation plaque burden (%)
Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign)
Pericoronary adipose tissue attenuation (Hounsfield units)
Plasma LDL cholesterol (mmol/l)
Plasma apolipoprotein B (g/l)
Full Information
NCT ID
NCT05352386
First Posted
April 22, 2022
Last Updated
March 13, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05352386
Brief Title
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
Acronym
CHEETAH
Official Title
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Heart Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with familial hypercholesterolemia, early treated
Arm Type
Other
Arm Title
Patients without familial hypercholesterolemia, late treated
Arm Type
Other
Arm Title
Healthy individuals
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Coronary computed tomography angiography (CCTA)
Intervention Description
Participants undergo coronary computed tomography angiography (CCTA)
Primary Outcome Measure Information:
Title
Total coronary plaque volume (mm3)
Time Frame
Day 0
Title
Total coronary plaque burden (%)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Presence of >50% obstructive stenosis per vessel
Time Frame
Day 0
Title
Presence of <50% nonobstructive stenosis per vessel
Time Frame
Day 0
Title
Calcified coronary plaque volume (mm^3)
Time Frame
Day 0
Title
Calcified coronary plaque burden (%)
Time Frame
Day 0
Title
Non-calcified plaque volume (mm^3)
Time Frame
Day 0
Title
Non-calcified plaque burden (%)
Time Frame
Day 0
Title
Low attenuation plaque volume (mm^3)
Time Frame
Day 0
Title
Low attenuation plaque burden (%)
Time Frame
Day 0
Title
Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign)
Time Frame
Day 0
Title
Pericoronary adipose tissue attenuation (Hounsfield units)
Time Frame
Day 0
Title
Plasma LDL cholesterol (mmol/l)
Time Frame
Day 0
Title
Plasma apolipoprotein B (g/l)
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
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