- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02870660
Familial Hypercholesterolemia Amongst Patients With Acute Coronary Syndrome
Identification of Familial Hypercholesterolemia Amongst Patients With Premature Acute Coronary Syndrome, Follow-up and Treatment
Familial hypercholesterolemia (FH) is a most prevalent genetic disorder, defines as high cholesterol level and premature death. The prevalence of FH has been reported in few countries however unknown in Iran. Thus recognize the FH patients, determine the diagnostic strategies and appropriate treatments are important.
Also acute coronary syndrome (ACS) is a group of conditions which arises from reduction of blood flow in coronary arteries. Three specific conditions are included: ST elevation myocardial infarction, non ST elevation myocardial infarction and unstable angina. Premature ACS defined by occurrence of ACS<55 for men and ACS<60 for women. Studies demonstrated direct connection between familial hypercholesterolemia and occurrence of premature ACS. Investigators intent to detection of FH amongst patients with acute coronary syndrome.
Study Overview
Status
Intervention / Treatment
Detailed Description
Familial hypercholesterolemia (FH) is a genetic disorder, defines as high cholesterol levels, particularly very high levels of low-density lipoprotein (LDL), in the blood and early cardiovascular events and premature death. FH is an autosomal dominant disease with a prevalence of 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 some specific population such as 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.
Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart.
A study in Switzerland has shown that 50% of patients with premature ACS have FH. Thus Investigators can screen FH with high probability amongst patients with acute coronary syndrome.
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 medication. 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.
Following scoring of patients, a one-year and 30-day survival model were created in order to assess the effect of elevated cholesterol on survival,.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Isfahan, Iran, Islamic Republic of
- Recruiting
- Isfahan cardio vascular research instiute
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Contact:
- Golnaz Vaseghi, PhD
- Phone Number: 0098 03136682736
- Email: golnazvaseghi@yahoo.com
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Principal Investigator:
- Nizal Sarrafzadegan, MD
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Sub-Investigator:
- Shaghayegh Haghjoo, PhD
-
Sub-Investigator:
- Mohammad reza Sabri, MD
-
Sub-Investigator:
- Masoud Pour moghaddas, MD
-
Sub-Investigator:
- Masoumeh Sadeghi, MD
-
Sub-Investigator:
- Mozhgan Gharipour, PhD
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Sub-Investigator:
- Azam Soleimanian, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients experienced premature cardiac events.
Exclusion Criteria:
- Previously registered FH.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Familial hypercholesterolemia amongst patients with premature acute coronary syndrome.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival time after hospitalization.
Time Frame: 30 days
|
30 days
|
Low Density Lipoprotein (LDL-C) at during follow-up.
Time Frame: 1 Year
|
1 Year
|
High Density Lipoprotein (HDL) at during follow-up.
Time Frame: 1 Year
|
1 Year
|
triglycerides (TG) at during follow-up.
Time Frame: 1 Year
|
1 Year
|
LDL-receptor 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
|
PCSK9 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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Disease
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Syndrome
- Hypercholesterolemia
- Acute Coronary Syndrome
- Hyperlipoproteinemia Type II
Other Study ID Numbers
- IsfahanICRI
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.
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