Clinical trial NCT03364387: Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Atrial Fibrillation
Diabetes Mellitus
Keywords: Acute Coronary Syndrome
MINOCA
Myocardial Infarction
Atrial Fibrillation
Lead sponsor: Cardiovascular Academy Society, Turkey
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 16026
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consisted patients with acute coronary syndrome undergoing invasive diagnostic coronary angiography.

Patients will eligible to take part in the study if they will fulfilled the criteria for acute myocardial infarction.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years
2. 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:

   i. Symptoms of ischaemia. ii. New or presumed new signiﬁcant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).

   iii. Development of pathological Q waves in the ECG. iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

   v. Identiﬁcation of an intracoronary thrombus by angiography.
3. Invasive diagnostic coronary angiography (IDCA) findings to allow determination of the presence /absence of obstructive coronary artery disease
4. Signed informed consent form to trial participation

Exclusion Criteria:

1. Inability/Refused to provide informed consent
2. Age below 18 years
3. 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)
4. Patients refused invasive diagnostic coronary angiography
5. Myocardial infarction associated with revascularization procedures

Primary outcomes:
measure: Composites of Myocardial Infarction, Hospitalization, Revascularization, Death
timeFrame: 12 months
Secondary outcomes:
measure: Atrial Fibrillation
timeFrame: 12 months
measure: Heart failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Emin Alioğlu
Study officials:
References: