Clinical trial NCT04241770: TURKish Acute Myocardial Infarction Registry
Official title: TURKish Acute Myocardial Infarction Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Mortality
Registry
Turkey
Lead sponsor: Turkish Society of Cardiology
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2020-01-27
Enrollment: 1930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants died
timeFrame: from enrollment till to 2 years follow up
Secondary outcomes:
measure: Number of participants developed cardiovascular morbidity
timeFrame: from enrollment till to 2 years follow up
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Meral Kayikcioglu
Study officials:
affiliation: Istanbul Private Sisli International Kolan Hospital,
name: MUSTAFA K EROL, prof
role: STUDY_DIRECTOR
affiliation: Ege University School of Medicine Department of Cardiology
name: MERAL KAYIKCIOGLU, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: ANKARA University School of Medicine Department of Cardiology
name: MUSTAFa KILICKAP, prof
role: PRINCIPAL_INVESTIGATOR
References: