NCT04414176

Brief Summary

This case-control study will be conducted all over the country (in Persian, Kurd, Azari, Arab, Lor, Bakhtiari, Baluch, Turkman, Qashqai, Gilak and in Muslims, Christians, Jewish, and Zoroastrian). the investigators intend to recruit patients (men 60≥ years of age and women 70≥ years of age) who underwent coronary angiography. Patients with coronary artery stenosis more than 75% (or left-main stenosis more than 50%) are defined as case group and patients with normal angiography are considered as the control group. at the same time, the prevalence of premature coronary artery disease in patients with positive angiography will be calculated.

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration 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 25, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

January 11, 2020

Last Update Submit

May 29, 2020

Conditions

Keywords

Premature coronary heart diseaseEthnicityReligionBiobank

Outcome Measures

Primary Outcomes (1)

  • Odds ratio

    Odds ratio for life style risk factors among different ethnicities and religions

    2018 to 2020

Study Arms (2)

Case

Patients with coronary artery stenosis more than 75% (or left-main stenosis more than 50%) are defined as case group

Control

Patients with normal angiography are considered as control group.

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with documented coronary angiography

You may qualify if:

  • Men and women less than 60 and 70 years respectively
  • Ethnicity
  • Coronary artery stenosis more than 75% (or left-main stenosis more than 50%) or patients with normal angiography

You may not qualify if:

  • patients with past medical history of CABG or documented coronary stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan Cardiovascular Research Institute

Isfahan, 8158388994, Iran

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be evaluated for fasting blood sugar and lipid profiles. All biological samples (serum, plasma, buffy coat, whole blood, urine, stool, and saliva) will be transferred to the central lab of the Isfahan Cardiovascular Research Institute to create a biobank (-80 c) for future genetic and epigenetic studies.

Central Study Contacts

Ehsan Zarepur, MD

CONTACT

Nizal Sarrafzadegan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ehsan Zarepur (Cardiology resident, PhD candidate)

Study Record Dates

First Submitted

January 11, 2020

First Posted

June 4, 2020

Study Start

August 25, 2018

Primary Completion

August 30, 2020

Study Completion

December 30, 2020

Last Updated

June 4, 2020

Record last verified: 2020-05

Locations