Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia (CHEETAH)

March 13, 2023 updated by: E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC, location AMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total coronary plaque volume (mm3)
Time Frame: Day 0
Day 0
Total coronary plaque burden (%)
Time Frame: Day 0
Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Dutch Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Actual)

December 19, 2022

Study Completion (Actual)

December 19, 2022

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79640.018.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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