Developing and Implementing Familial Hypercholesterolemia Registry
1 other identifier
observational
500
1 country
1
Brief Summary
Familial hypercholesterolemia (FH) is a most prevalent genetic disorder define as high cholesterol level and premature death. The prevalence of FH reported in few countries however unknown in Iran. Thus determine the FH patient, finding diagnostic strategy and appropriate treatment are important. We intent to use cascade method to screening patients, also our expected outputs are to develop and implement a registry program for FH patients and their families and to study their genetic disorder. FH patients will be followed from management, treatment and prevention of Cardio vascular disease in order to increase premature death.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 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
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 16, 2016
August 1, 2016
1.1 years
August 10, 2016
August 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients with FH.
1 Year
Secondary Outcomes (7)
Number of premature cardio vascular events annually follow-up.
5 Years
Low Density Lipoprotein (LDL-C) at base line and during annually follow-up.
1 Year
High density lipoprotein (HDL) at base line and during annually follow-up.
1 Year
triglyceride (TG) at base line and during annually follow-up.
1 Year
LDL-receptor frequency of mutation in Persian population.
1 Year
- +2 more secondary outcomes
Interventions
Eligibility Criteria
Patients from clinical laboratory.
You may qualify if:
- Personal concentration of LDL-C \> 190 mg/dL or LDL-C \> 120 mg/dL in Treatment Group.
- Family and/or personal history of premature heart disease.
You may not qualify if:
- Hyperlipidemia with underlying disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Isfahan Cardio vascular Research Institute
Isfahan, Iran
Biospecimen
Plasma, buffy coat, blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pediatric Cardio vascular research Center
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 12, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2021
Last Updated
August 16, 2016
Record last verified: 2016-08