- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02865694
Developing and Implementing Familial Hypercholesterolemia Registry
Developing and Implementing Familial Hypercholesterolemia Registry in Isfahan, Iran: Cascade Screening, Management and Long-term Follow up.
Study Overview
Detailed Description
Familial hypercholesterolemia (FH) is a genetic disorder define as high cholesterol levels, particularly very high levels of low-density lipoprotein (LDL), in the blood and early cardiovascular disease and premature death. FH is an autosomal dominant disease with a prevalence 1:500 (new study in Netherlands demonstrated 1:244) in population more frequent than Cystic fibrosis, mellitus diabetes or neonatal hypothyroidism. Canadian registry demonstrated FH is more common among people if French Canadian, Christian Lebanese, and Afrikaner descent. The Major causes of FH are pathogenic variant in the LDL-receptor (LDLR) gene or the Apo lipoprotein B (APOB) gene. The clinical signs of FH are high level of Cholesterol (between 350-550 mg/dL in heterozygous), Yellow deposits of cholesterol-rich fat in various places on the body such as around the eyelids (known as xanthelasma palpebrarum), the outer margin of the iris (known as arcus senilis corneae), and in the tendons of the hands, elbows, knees and feet, particularly the Achilles tendon (known as a tendon xanthoma). FH is a hidden syndrome which leads to cardiovascular disease.
After introducing the statins total mortality have reduced significantly in these patients. Thus screening and identification of patients and treatment with the most effective therapies will decrease the risk of premature death.
Also, most of patients require an appropriate lipid-lowering medications. Although the genetic problem is the most important factor to expression of FH other factors like environmental and metabolic factor can be effective in CVD and premature death.
Therefore, identification and follow-up FH patients is important for CVD Rate cuts and decrease Treatment costs thus this study can gain these outcomes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohammad reza Sabri, MD
- Phone Number: 0098 03136682736
- Email: sabrimrs@gmail.com
Study Locations
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Isfahan, Iran, Islamic Republic of
- Recruiting
- Isfahan Cardio vascular Research Institute
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Principal Investigator:
- Nizal Sarrafzadegan, MD
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Contact:
- Mohammad reza Sabri, MD
- Phone Number: 0098 03136682736
- Email: sabrimrs@gmail.com
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Principal Investigator:
- Sina Arabi, Medical Student
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Principal Investigator:
- Shaghayegh Haghjoo, PhD
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Principal Investigator:
- Golnaz Vaseghi, PhD
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Principal Investigator:
- Mozhgan Gharipour, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Hyperlipidemia with underlying disorders.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Patients with FH.
Time Frame: 1 Year
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of premature cardio vascular events annually follow-up.
Time Frame: 5 Years
|
5 Years
|
Low Density Lipoprotein (LDL-C) at base line and during annually follow-up.
Time Frame: 1 Year
|
1 Year
|
High density lipoprotein (HDL) at base line and during annually follow-up.
Time Frame: 1 Year
|
1 Year
|
triglyceride (TG) at base line and during annually follow-up.
Time Frame: 1 Year
|
1 Year
|
LDL-receptor frequency of mutation in Persian population.
Time Frame: 1 Year
|
1 Year
|
PCSK9 frequency of mutation in Persian population.
Time Frame: 1 Year
|
1 Year
|
Apo-B frequency of mutation in Persian population.
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FH-ICRI
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.
Clinical Trials on Familial Hypercholesterolemia
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National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
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Regeneron PharmaceuticalsSanofiTerminatedHeterozygous Familial Hypercholesterolemia | Non-familial HypercholesterolemiaUnited States, Bulgaria, Estonia, Russian Federation, South Africa, Ukraine
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Merck Sharp & Dohme LLCTerminatedHypercholesterolemia, Familial | Heterozygous Familial Hypercholesterolemia
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Institut Investigacio Sanitaria Pere VirgiliRecruitingFamilial Hypercholesterolemia | Familial Hypercholesterolemia - Homozygous | Familial Hypercholesterolemia - HeterozygousSpain
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Novartis PharmaceuticalsActive, not recruitingFamilial Hypercholesterolemia - HomozygousGreece, Lebanon, Turkey, France, Canada, Malaysia, Netherlands, United States
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Novartis PharmaceuticalsRecruitingHeterozygous or Homozygous Familial HypercholesterolemiaNetherlands, Israel, Hungary, Italy, Germany, Spain, France, Norway, South Africa, Turkey, United Kingdom, Canada, Switzerland, Brazil, Lebanon, Slovenia, United States, Russian Federation, Taiwan
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Novartis PharmaceuticalsCompletedElevated Cholesterol | Homozygous Familial Hypercholesterolemia | Heterozygous Familial Hypercholesterolemia | ASCVDUnited States, Canada, Czechia, Denmark, Germany, Hungary, Netherlands, Poland, South Africa, Spain, Sweden, Ukraine, United Kingdom
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REGENXBIO Inc.National Heart, Lung, and Blood Institute (NHLBI)TerminatedHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Italy, Netherlands
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Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
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University of British ColumbiaVancouver Coastal Health Research Institute; Genome British ColumbiaRecruitingAcute Coronary Syndrome | Familial Hypercholesterolemia | STEMI | NSTEMI - Non-ST Segment Elevation MI | Familial Hypercholesterolemia - Heterozygous | Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B | Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation and other conditionsCanada
Clinical Trials on Cascade
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Claremont Graduate UniversityAHMC Health FoundationCompletedType 2 DiabetesUnited States
-
WaveForm Technologies Inc.UnknownContinuous Glucose Monitoring
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University of Puget SoundCompleted
-
WaveForm Technologies Inc.CompletedEfficacy of a 21-Day Wear Period for the Cascade CGMCroatia, Slovenia
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Canterbury Christ Church UniversityInterreg 2 Seas Mers ZeeenWithdrawn
-
University of BaselRecruitingLynch Syndrome | Hereditary Breast and Ovarian CancerSwitzerland
-
Northwestern UniversityUniversity of Pennsylvania; Family Heart FoundationEnrolling by invitationFamilial HypercholesterolemiaUnited States
-
NYU Langone HealthRecruitingMLH1 Gene Mutation | RAD51C Gene Mutation | BRIP1 Gene Mutation | MSH6 Gene Mutation | PMS2 Gene Mutation | BRCA-Mutated Ovarian Carcinoma | MSH2 A636P | EPCAMUnited States
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University of Maryland, BaltimoreNational Human Genome Research Institute (NHGRI)Terminated
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Baxter Healthcare CorporationGambro Lundia ABCompleted