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Trial record 26 of 75 for:    Recruiting, Not yet recruiting, Available Studies | "Hypercholesterolemia"

Familial Hypercholesterolemia Amongst Patients With Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT02870660
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Golnaz Vaseghi, Isfahan University of Medical Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment
Familial Hypercholesterolemia Cardiac Event Acute Coronary Syndrome Other: Registry

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,.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Identification of Familial Hypercholesterolemia Amongst Patients With Premature Acute Coronary Syndrome, Follow-up and Treatment
Study Start Date : August 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of Familial hypercholesterolemia amongst patients with premature acute coronary syndrome. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Survival time after hospitalization. [ Time Frame: 30 days ]
  2. Low Density Lipoprotein (LDL-C) at during follow-up. [ Time Frame: 1 Year ]
  3. High Density Lipoprotein (HDL) at during follow-up. [ Time Frame: 1 Year ]
  4. triglycerides (TG) at during follow-up. [ Time Frame: 1 Year ]
  5. LDL-receptor frequency of mutation in Persian Population. [ Time Frame: 1 Year ]
  6. Apo-B frequency of mutation in Persian Population. [ Time Frame: 1 Year ]
  7. PCSK9 frequency of mutation in Persian Population. [ Time Frame: 1 Year ]

Biospecimen Retention:   Samples With DNA
Plasma, buffy coat, blood.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
participating with premature ACS across Isfahan hospitals.
Criteria

Inclusion Criteria:

  • Patients experienced premature cardiac events.

Exclusion Criteria:

  • Previously registered FH.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870660


Locations
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Iran, Islamic Republic of
Isfahan cardio vascular research instiute Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Golnaz Vaseghi, PhD    03136682736 ext 0098    golnazvaseghi@yahoo.com   
Principal Investigator: Nizal Sarrafzadegan, MD         
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         
Sub-Investigator: Azam Soleimanian, MD         
Sponsors and Collaborators
Isfahan University of Medical Sciences

Additional Information:

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Responsible Party: Golnaz Vaseghi, Research Vice Chancellor, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02870660     History of Changes
Other Study ID Numbers: IsfahanICRI
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Hypercholesterolemia
Acute Coronary Syndrome
Hyperlipoproteinemia Type II
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias