NCT03957005

Brief Summary

This study aims to investigate life-style and psycho social factors of major cardiovascular events in patients with myocardial infarction in three different provinces of Iran and to design a risk assessment chart for major cardiovascular events in patients with MI.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

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

November 6, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

4.5 years

First QC Date

May 17, 2019

Last Update Submit

May 17, 2019

Conditions

Keywords

Myocardial InfarctionMajor cardiovascular eventsRisk assessment

Outcome Measures

Primary Outcomes (1)

  • Incidence of MCE within follow up period

    MCE includes two type of CV events: coronary artery disease-specific (MI, unstable angina (hospitalized angina), coronary revascularization or death from coronary heart disease) and cerebrovascular disease-specific events (ischemic or hemorrhagic stroke, transient ischemic attack, cerebrovascular disease-specific revascularization or death from cerebrovascular disease).

    From enrollment up to 36 months of followup

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will perform in three referral hospitals of Tehran, Isfahan and Bandarabbas counties. Participants of this study will be those hospitalized because of their first myocardial infarction.

You may qualify if:

  • clinically verified diagnosis of the first episode ST-elevation myocardial infarction
  • providing written informed consent

You may not qualify if:

  • history of prior documented CVD
  • living in a nursing home or other institutions
  • having a serious medical condition with a survival of less than 3 years
  • participation in another scientific study
  • not willing to participate in each phase of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr Heshmat Hospital

Rasht, Gilan Province, Iran

RECRUITING

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, Iran

RECRUITING

Chamran Cardiology Hospital

Isfahan, Iran

RECRUITING

Shahid Rajaei hospital

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Masoumeh Sadeghi, MD

    Cardiac Rehabilitation Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamidreza Roohafza, MD

CONTACT

Shervin Gh Hoseini, MD. PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiac Rehabilitation Research Center

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

November 6, 2018

Primary Completion

May 1, 2023

Study Completion

November 1, 2023

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months after study publication.

Locations