NCT02870660

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

August 7, 2016

Last Update Submit

November 29, 2017

Conditions

Familial HypercholesterolemiaCardiac EventAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of Familial hypercholesterolemia amongst patients with premature acute coronary syndrome.

    1 year

Secondary Outcomes (7)

  • Survival time after hospitalization.

    30 days

  • Low Density Lipoprotein (LDL-C) at during follow-up.

    1 Year

  • High Density Lipoprotein (HDL) at during follow-up.

    1 Year

  • triglycerides (TG) at during follow-up.

    1 Year

  • LDL-receptor frequency of mutation in Persian Population.

    1 Year

  • +2 more secondary outcomes

Interventions

RegistryOTHER

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

participating with premature ACS across Isfahan hospitals.

You may qualify if:

  • Patients experienced premature cardiac events.

You may not qualify if:

  • Previously registered FH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan cardio vascular research instiute

Isfahan, Iran

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, buffy coat, blood.

MeSH Terms

Conditions

Hyperlipoproteinemia Type IICardiovascular DiseasesAcute Coronary Syndrome

Interventions

Registries

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Vice Chancellor

Study Record Dates

First Submitted

August 7, 2016

First Posted

August 17, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2021

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations

IR(1)