Atherosclerosis in Familial Hypercholesterolemia
Incidence and Characteristics of Coronary Atherosclerosis in Asymptomatic Patients With Familial Hypercholesterolemia According to Monogenic Versus Polygenic Status
1 other identifier
observational
100
1 country
1
Brief Summary
Familial hypercholesterolemia (FH) is a common inherited disorder with a frequency of 1 in 500 in the UK. Our aim is compare the carotid and coronary artery atherosclerosis in monogenic FH and polygenic hypercholesterolemia with means of a carotid ultrasound, a coronary CT angiogram and biochemical biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 2, 2015
July 1, 2015
2 years
July 1, 2015
July 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
carotid Intima Media thickness measurement
done by carotid ultrasound to look for risk of atherosclerosis
24 months
Study Arms (2)
polygenic hypercholesterolemia
patients with high cholesterol level where no mutation was found in their FH-causing genes and had to gene score in their six LDL-C raising gene score undergo a carotid ultrasound, a CT coronary angiogram and a blood test
monogenic FH
patients with a mutation in FH-causing gene undergo a carotid ultrasound, a CT coronary angiogram and a blood test
Interventions
Scans in addition to routine clinical care
Eligibility Criteria
50 monogenic FH and 50 polygenic hypercholesterolemia
You may qualify if:
- The subjects must give written informed consent to participate in the study, Male and female subjects ≥ 18 years old, documentation of clinical diagnosis of familial Hypercholesterolemia
You may not qualify if:
- Estimated GFR \<45, pregnant women, Atrial fibrillation or unstable heart rate, Established ischemic heart disease, previous Percutaneous Coronary Investigations (PCI) or Coronary Artery Bypass Surgery (CABG), Known allergy to iodine contrast
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Free Hospital
London, London, NW3 2QG, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roby Rakhit
University College Hospital and Royal Free Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 2, 2015
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
December 1, 2016
Last Updated
July 2, 2015
Record last verified: 2015-07