Familial HypercholesterolemiaCHEETAHNCT05352386
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
A study testing Coronary computed tomography angiography (CCTA) in people with Familial Hypercholesterolemia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Coronary computed tomography angiography (CCTA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Mar 2022to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed with heterozygous familial hypercholesterolemia or non FH-control
- Adult patients between 25 and 55 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Coronary computed tomography angiography (CCTA)
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary computed tomography angiography (CCTA)Diagnostic test
Participants undergo coronary computed tomography angiography (CCTA)
| Study group | Role | What they receive |
|---|---|---|
| Patients with familial hypercholesterolemia, early treated | Other | Not described Receives: Diagnostic Test: Coronary computed tomography angiography (CCTA) |
| Patients without familial hypercholesterolemia, late treated | Other | Not described Receives: Diagnostic Test: Coronary computed tomography angiography (CCTA) |
| Healthy individuals | Other | Not described Receives: Diagnostic Test: Coronary computed tomography angiography (CCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total coronary plaque volume (mm3)
Measured: Day 0
Total coronary plaque burden (%)
Measured: Day 0
Secondary outcomes (12)
Presence of >50% obstructive stenosis per vessel
Measured: Day 0
Presence of <50% nonobstructive stenosis per vessel
Measured: Day 0
Calcified coronary plaque volume (mm^3)
Measured: Day 0
Calcified coronary plaque burden (%)
Measured: Day 0
Non-calcified plaque volume (mm^3)
Measured: Day 0
Non-calcified plaque burden (%)
Measured: Day 0
Low attenuation plaque volume (mm^3)
Measured: Day 0
Low attenuation plaque burden (%)
Measured: Day 0
Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign)
Measured: Day 0
Pericoronary adipose tissue attenuation (Hounsfield units)
Measured: Day 0
Plasma LDL cholesterol (mmol/l)
Measured: Day 0
Plasma apolipoprotein B (g/l)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start7 Mar 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Principal investigator, E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352386
- Sponsor's protocol ID
- NL79640.018.21
- Acronym
- CHEETAH
- Status last verified
- Mar 2023
- First submitted
- 22 Apr 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05352386
- Acronym / sponsor ID
- CHEETAH / NL79640.018.21
- Conditions
- Familial Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with familial hypercholesterolemia, early treated | Other | Diagnostic Test: Coronary computed tomography angiography (CCTA) |
| Patients without familial hypercholesterolemia, late treated | Other | Diagnostic Test: Coronary computed tomography angiography (CCTA) |
| Healthy individuals | Other | Diagnostic Test: Coronary computed tomography angiography (CCTA) |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with heterozygous familial hypercholesterolemia or non FH-control
- Adult patients between 25 and 55 years old.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary computed tomography angiography (CCTA)Participants undergo coronary computed tomography angiography (CCTA) | Diagnostic test | Healthy individuals, Patients with familial hypercholesterolemia, early treated, Patients without familial hypercholesterolemia, late treated |
Primary outcome
Total coronary plaque volume (mm3)
Time frame: Day 0
Total coronary plaque burden (%)
Time frame: Day 0
12 secondary outcomes
Presence of >50% obstructive stenosis per vessel
Time frame: Day 0
Presence of <50% nonobstructive stenosis per vessel
Time frame: Day 0
Calcified coronary plaque volume (mm^3)
Time frame: Day 0
Calcified coronary plaque burden (%)
Time frame: Day 0
Non-calcified plaque volume (mm^3)
Time frame: Day 0
Non-calcified plaque burden (%)
Time frame: Day 0
Low attenuation plaque volume (mm^3)
Time frame: Day 0
Low attenuation plaque burden (%)
Time frame: Day 0
Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign)
Time frame: Day 0
Pericoronary adipose tissue attenuation (Hounsfield units)
Time frame: Day 0
Plasma LDL cholesterol (mmol/l)
Time frame: Day 0
Plasma apolipoprotein B (g/l)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
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Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary computed tomography angiography (CCTA) in people with Familial Hypercholesterolemia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total coronary plaque volume (mm3) (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.