MINOCA-TR: Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population

Sponsor

Cardiovascular Academy Society, Turkey (Other)

Overall Status

Completed

CT.gov ID

NCT03364387

Collaborator

(none)

16,026

Enrollment

Location

3.4

Actual Duration (Months)

4782.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to analyze the Demographics, Clinical Profiles, Management, in-Hospital and Long-Term Outcomes of Patients with Acute Coronary Syndrome Syndrome And Myocardial Infarction with Non-obstructive Coronary Artery Disease.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Myocardial Infarction Atrial Fibrillation Diabetes Mellitus

Detailed Description

Acute coronary syndrome is leading causes of death worldwide. Although, >90% of these patients had of culprit coronary lesion, a significant proportion of them had no any angiographic evidence of obstructive coronary arteries. Exact mechanism of the myocardial infarction remains unclear of these patients. However, MI registries have reported that the 5% to %10 of MI patients have no evidence of obstructive coronary artery disease.

There is lack of any data regarding prevalence, demographics, patients' profile, management, and outcome of this clinical entity in Turkish population. This registry aims to obtain these data in Myocardial Infarction with Non-obstructive Coronary Artery Disease patients in Turkish population.

Although there are huge data in this issue from different country and geographic areas, to date no any national data about prevalence, demographics, management and in-hospital outcomes of AF patients who admitting with cute coronary syndrome. With this rationale the registry also aims to obtain demographics, clinical profile, management, and in-hospital outcome of AF in Turkish Acute coronary syndrome population.

Study Design

Study Type:

Observational

Actual Enrollment :

16026 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Clinical Profile, Management and Long-Term Outcomes of Patients With Acute Coronary Syndrome and Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population

Actual Study Start Date :

Mar 5, 2018

Actual Primary Completion Date :

May 15, 2018

Actual Study Completion Date :

Jun 15, 2018

Outcome Measures

Primary Outcome Measures

Composites of Myocardial Infarction, Hospitalization, Revascularization, Death [12 months]
Re-infarction, Any cause or Cardiovascular Hospitalization or Death

Secondary Outcome Measures

Atrial Fibrillation [12 months]
Any type of atrial fibrillation
Heart failure [12 months]
Acute decompensated heart failure with or without cardiogenic shock

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients older than 18 years
Evidence of an MI as defined any one of the following criteria:

Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:

Symptoms of ischaemia. ii. New or presumed new signiﬁcant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
Development of pathological Q waves in the ECG. iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Identiﬁcation of an intracoronary thrombus by angiography.

Invasive diagnostic coronary angiography (IDCA) findings to allow determination of the presence /absence of obstructive coronary artery disease
Signed informed consent form to trial participation

Exclusion Criteria:

Inability/Refused to provide informed consent
Age below 18 years
Patients with unstable angina pectoris (ACS without increase and/or decrease of a cardiac biomarker, preferably high-sensitivity cardiac troponin, with at least one value above the 99th percentile of the upper reference limit)
Patients refused invasive diagnostic coronary angiography
Myocardial infarction associated with revascularization procedures