Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-20 @ 6:48 PM
Study NCT ID:
NCT02870660
Status:
UNKNOWN
Last Update Posted:
2017-11-30
First Post:
2016-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Familial Hypercholesterolemia Amongst Patients With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, buffy coat, blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2016-08-07', 'studyFirstSubmitQcDate': '2016-08-13', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Familial hypercholesterolemia amongst patients with premature acute coronary syndrome.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Survival time after hospitalization.', 'timeFrame': '30 days'}, {'measure': 'Low Density Lipoprotein (LDL-C) at during follow-up.', 'timeFrame': '1 Year'}, {'measure': 'High Density Lipoprotein (HDL) at during follow-up.', 'timeFrame': '1 Year'}, {'measure': 'triglycerides (TG) at during follow-up.', 'timeFrame': '1 Year'}, {'measure': 'LDL-receptor frequency of mutation in Persian Population.', 'timeFrame': '1 Year'}, {'measure': 'Apo-B frequency of mutation in Persian Population.', 'timeFrame': '1 Year'}, {'measure': 'PCSK9 frequency of mutation in Persian Population.', 'timeFrame': '1 Year'}]}, 'conditionsModule': {'conditions': ['Familial Hypercholesterolemia', 'Cardiac Event', 'Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nAlso 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.', 'detailedDescription': '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.\n\nAcute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart.\n\nA 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.\n\nAfter 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.\n\nAlso, 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.\n\nFollowing scoring of patients, a one-year and 30-day survival model were created in order to assess the effect of elevated cholesterol on survival,.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'participating with premature ACS across Isfahan hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients experienced premature cardiac events.\n\nExclusion Criteria:\n\n* Previously registered FH.'}, 'identificationModule': {'nctId': 'NCT02870660', 'briefTitle': 'Familial Hypercholesterolemia Amongst Patients With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Identification of Familial Hypercholesterolemia Amongst Patients With Premature Acute Coronary Syndrome, Follow-up and Treatment', 'orgStudyIdInfo': {'id': 'IsfahanICRI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Registry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Golnaz Vaseghi, PhD', 'role': 'CONTACT', 'email': 'golnazvaseghi@yahoo.com', 'phone': '03136682736', 'phoneExt': '0098'}, {'name': 'Nizal Sarrafzadegan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shaghayegh Haghjoo, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohammad reza Sabri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Masoud Pour moghaddas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Masoumeh Sadeghi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mozhgan Gharipour, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Azam Soleimanian, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Isfahan cardio vascular research instiute', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Vice Chancellor', 'investigatorFullName': 'Golnaz Vaseghi', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}