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Coronary VesselsI-PADNCT04414176

Iran- Premature Coronary Artery Disease

An observational study of Coronary Vessels, run by Isfahan University of Medical Sciences at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages Up to 70 years
Conditions the study is for
Coronary Vessels
How many people
5,000 participants
Where
1 siteIran
Study dates
25 Aug 2018to 30 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: patients with documented coronary angiography

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ehsan Zarepur, MD contact

+98 3136115109

ehsanzarepur@gmail.com

Nizal Sarrafzadegan, MD contact

+98 3136115310

nsarrafzadegan@gmail.com

Iran1 site, 1 recruiting
  • Isfahan Cardiovascular Research Institute

    Isfahan, 8158388994

    Ehsan Zarepur, M.D., +983136115109, ehsanzarepur@gmail.com

    Recruiting

Other trials in Iran

About this study

Official title: Determining the Prevalence of Premature Coronary Heart Disease and it's Risk Factors According to Different Ethnicities and Religions in Iran and Developing a Biobank for Genetic and Epigenetic Studies

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.

Read the detailed description

Coronary heart disease (CHD) is one of the most important causes of mortality in the world and accounts for up to 30% of deaths. CHD is also prevalent in Iran and in some studies, the prevalence of the disease has been reported to be about 20 to 30 percent. The prevalence of premature coronary heart disease (CHD) is increasing every year, which is related to the risk factors for cardiovascular disease in humans. The prevalence of premature CHD in Iran is also high, which justify better understanding of the factors affecting it.

Many known risk factors are involved in coronary artery disease, including age, sex, obesity, high blood pressure, diabetes, dyslipidemia, smoking and family history. These risk factors do not have the same prevalence or attributable risk among different ethnicities and religions. Also due to genetic differences, the effect of environmental factors can accelerate or diminish the effects of some factors on the occurance of premature CHD. These mechanisms are often unknown, but high-risk environments can trigger an earlier onset of CHD in people who are genetically susceptible. This relation is called the genetic-environment interaction. As showed in previous reports, CHD is a multifactorial disease that can be affected by environmental factors and expression of different genes.

In this case-control study the investigators intend to recruit documented CHD patients who underwent coronary angiography from diverse ethnic and religious groups. A total of 5000 individuals from different ethnic backgrounds such as Persian (fars), Turk, Kurd, Arab, Lor, Bakhtiari, Baluch, Turkman, Qashqai, Gilak and in Muslims, Christians, Jews, and Zoroastrians will be selected throughout the country. Sampling among different ethnicities and religions will be based on their proportion of the total population.

Variables such as age, sex, ethnicity, religion, socioeconomic characteristics (educational level, working status, income), history of smoking, alcohol consumption, addiction, family and personal history of CHD, psychosocial habit, physical activity, and dietary habits will be collected. The heart rate and systolic and diastolic blood pressure will be taken twice in sitting position, and under standard conditions and the average of the two measurements will be recorded. The patient's weight (in kilograms), and height (in meters), the circumference of the wrist, neck, thigh, waist, and hip (all in centimeters) will be measured in light clothes and without shoes and body mass index and waist to hip ratio will be calculated.

Blood samples will be evaluated for fasting blood sugar and lipid profiles (Triglyceride, High-density lipoprotein-C, Low-density lipoprotein-C, and Total Cholesterol).

Samples of serum, plasma, buffy coat, whole blood, urine, stool, and saliva will be frozen and Individuals genetic and epigenetic variations will be examined in later stages.

All biological Samples will be transferred to the central lab of the Isfahan Cardiovascular Research Institute to create a BioBank for future genetic and epigenetic studies. The data collection teams will receive the necessary training in several sessions and the supervisory committee will regularly monitor the implementation of the plan.

Keywords
Premature coronary heart disease, Ethnicity, Religion, Biobank

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04414176
Study groupRoleWhat they receive
CasePatients with coronary artery stenosis more than 75% (or left-main stenosis more than 50%) are defined as case group
ControlPatients with normal angiography are considered as control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Odds ratio

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

    Measured: 2018 to 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start25 Aug 2018
  3. Primary completion30 Aug 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414176
Sponsor's protocol ID
296055
Acronym
I-PAD
Status last verified
May 2020
First submitted
11 Jan 2020
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Vessels, run by Isfahan University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ehsan Zarepur, MD (+98 3136115109, ehsanzarepur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Odds ratio (time frame: 2018 to 2020). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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