Viewing Study NCT02870660



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Last Modification Date: 2024-10-26 @ 12:08 PM
Study NCT ID: NCT02870660
Status: UNKNOWN
Last Update Posted: 2017-11-30
First Post: 2016-08-07

Brief Title: Familial Hypercholesterolemia Amongst Patients With Acute Coronary Syndrome
Sponsor: Isfahan University of Medical Sciences
Organization: Isfahan University of Medical Sciences

Study Overview

Official Title: Identification of Familial Hypercholesterolemia Amongst Patients With Premature Acute Coronary Syndrome Follow-up and Treatment
Status: UNKNOWN
Status Verified Date: 2017-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ACS55 for men and ACS60 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
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 1500 new study in Netherlands demonstrated 1244 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 mgdL 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 xanthomaFH 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None