TURKish Acute Myocardial Infarction Registry (TURKMI)

January 31, 2020 updated by: Turkish Society of Cardiology
There is no up-to-date information regarding presentation, management and clinical course of patients with acute myocardial infarction (MI) in Turkey. TURKMI registry is designed to provide insight to the characteristics, management from symptom onset to the hospital discharge and outcome of patients with acute MI in Turkey.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: There is no up-to-date information regarding presentation, management and clinical course of patients with acute myocardial infarction (MI) in Turkey. TURKMI registry is designed to provide insight to the characteristics, management from symptom onset to the hospital discharge and outcome of patients with acute MI in Turkey.

Methods: TURKMI study, as a nation-wide registry, will be conducted in 50 percutaneous coronary intervention -capable centres selected from each EuroStat NUTS region in Turkey according to their population sampling weight, prioritizing the volume of hospital in each region. All consecutive patients with acute MI admitted to the coronary care units within the 48 hours of symptom onset will be prospectively enrolled during a predefined 2-week period.

The first step of the study has cross-sectional design in which baseline information such as symptoms, risk factors, time periods at each step from symptom onset to revascularization, way of arrival to hospital, biochemical analysis and in-hospital management and outcome will be assessed. The second step has a cohort characteristics in which enrolled patients will be followed-up up to 2 years. Follow-up visits will be conducted at 1st, 6th, 12th and 24th months, and predictors and risk of cardiovascular events, and implementation of guidelines will be assessed as secondary outcomes.

Conclusion: The national TURKMI registry is expected to provide important information to improve the national policy of the diagnosis, management and outcomes of MI in Turkey

Study Type

Observational

Enrollment (Anticipated)

1930

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The screened population will consist of all consecutive patients presenting with suspected acute MI in the participating hospitals. Men and women aged ≥18 years will be enrolled if they fulfil the following inclusion criteria;

  1. having hospitalized within 48 hours of onset of symptoms of the index event
  2. had a final (discharge) diagnosis of acute MI either [ST elevation MI (STEMI) or non ST elevation (NSTEMI)] with positive troponin levels, and
  3. having signed an Informed Consent. Patients unwilling or unable to consent will be excluded. To facilitate consecutive enrolment, all patients hospitalized at each participating site with acute MI will be recruited consecutively during the same 2 consecutive weeks (15 days).

Description

Inclusion Criteria:

  1. having hospitalized within 48 hours of onset of symptoms of the index event
  2. had a final (discharge) diagnosis of acute MI either [ST elevation MI (STEMI) or non ST elevation (NSTEMI)] with positive troponin levels, and
  3. having signed an Informed Consent. To facilitate consecutive enrolment, all patients hospitalized at each participating site with acute MI will be recruited consecutively during the same 2 consecutive weeks (15 days).

Exclusion Criteria:

1. Patients unwilling or unable to consent will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants died
Time Frame: from enrollment till to 2 years follow up
all cause of death including cardiovascular death
from enrollment till to 2 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants developed cardiovascular morbidity
Time Frame: from enrollment till to 2 years follow up
non-fatal MI, stroke, coronary or peripheral revascularization, emergency department visit due to chest pain or dyspnea, hospitalization for heart failure will be assessed at 1st month and then at every 6 month intervals until the second year.
from enrollment till to 2 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Society of Cardiology

Collaborators

AstraZeneca

Investigators

  • Study Director: MUSTAFA K EROL, prof, Istanbul Private Sisli International Kolan Hospital,
  • Principal Investigator: MERAL KAYIKCIOGLU, prof, Ege University School of Medicine Department of Cardiology
  • Principal Investigator: MUSTAFa KILICKAP, prof, ANKARA University School of Medicine Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TURKMI Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe