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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04241770
Other study ID # TURKMI Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date December 31, 2023

Study information

Verified date January 2020
Source Turkish Society of Cardiology
Contact MERAL KAYIKCIOGLU, Prof
Phone +905324123489
Email meral.kayikcioglu@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 1930
Est. completion date December 31, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
Turkey Meral Kayikcioglu Izmir

Sponsors (2)

Lead Sponsor Collaborator
Turkish Society of Cardiology AstraZeneca

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants died all cause of death including cardiovascular death from enrollment till to 2 years follow up
Secondary Number of participants developed cardiovascular morbidity 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
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