CHEETAH: Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05352386
• Collaborator: Dutch Heart Foundation (Other)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 13.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Familial Hypercholesterolemia	Diagnostic Test: Coronary computed tomography angiography (CCTA)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
• Actual Study Start Date: Mar 7, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with familial hypercholesterolemia, early treated	Diagnostic Test: Coronary computed tomography angiography (CCTA); Participants undergo coronary computed tomography angiography (CCTA)
Other: Patients without familial hypercholesterolemia, late treated	Diagnostic Test: Coronary computed tomography angiography (CCTA); Participants undergo coronary computed tomography angiography (CCTA)
Other: Healthy individuals	Diagnostic Test: Coronary computed tomography angiography (CCTA); Participants undergo coronary computed tomography angiography (CCTA)

Outcome Measures

Primary Outcome Measures

1. Total coronary plaque volume (mm3) [Day 0]

2. Total coronary plaque burden (%) [Day 0]

Secondary Outcome Measures

1. Presence of >50% obstructive stenosis per vessel [Day 0]

2. Presence of <50% nonobstructive stenosis per vessel [Day 0]

3. Calcified coronary plaque volume (mm^3) [Day 0]

4. Calcified coronary plaque burden (%) [Day 0]

5. Non-calcified plaque volume (mm^3) [Day 0]

6. Non-calcified plaque burden (%) [Day 0]

7. Low attenuation plaque volume (mm^3) [Day 0]

8. Low attenuation plaque burden (%) [Day 0]

9. Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign) [Day 0]

10. Pericoronary adipose tissue attenuation (Hounsfield units) [Day 0]

11. Plasma LDL cholesterol (mmol/l) [Day 0]

12. Plasma apolipoprotein B (g/l) [Day 0]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam UMC, location AMC	Amsterdam		Netherlands

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: E.S.stroes, Prof. dr. E.S.G.Stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT05352386
• Other Study ID Numbers: NL79640.018.21
• First Posted: Apr 28, 2022
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia

Study Results

No Results Posted as of Apr 28, 2022