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Completed

NCT Number: NCT05352386

Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

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

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Key information

Conditions

Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary computed tomography angiography (CCTA)

Diagnostic Test

Participants undergo coronary computed tomography angiography (CCTA)

Primary outcomes

  1. Total coronary plaque volume (mm3)

    Time frame: Day 0

  2. Total coronary plaque burden (%)

    Time frame: Day 0

Secondary outcomes

  1. Presence of >50% obstructive stenosis per vessel

    Time frame: Day 0

  2. Presence of <50% nonobstructive stenosis per vessel

    Time frame: Day 0

  3. Calcified coronary plaque volume (mm^3)

    Time frame: Day 0

  4. Calcified coronary plaque burden (%)

    Time frame: Day 0

  5. Non-calcified plaque volume (mm^3)

    Time frame: Day 0

  6. Non-calcified plaque burden (%)

    Time frame: Day 0

  7. Low attenuation plaque volume (mm^3)

    Time frame: Day 0

  8. Low attenuation plaque burden (%)

    Time frame: Day 0

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

    Time frame: Day 0

  10. Pericoronary adipose tissue attenuation (Hounsfield units)

    Time frame: Day 0

  11. Plasma LDL cholesterol (mmol/l)

    Time frame: Day 0

  12. Plasma apolipoprotein B (g/l)

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Dutch Heart Foundation

Registry information

Acronym: CHEETAH

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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