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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Diabetes Mellitus; Atrial Fibrillation; Acute Coronary Syndrome

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 Type: Observational
• Enrollment (Actual): 16026

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Emin Alioğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composites of Myocardial Infarction, Hospitalization, Revascularization, Death	Re-infarction, Any cause or Cardiovascular Hospitalization or Death	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation	Any type of atrial fibrillation	12 months
Heart failure	Acute decompensated heart failure with or without cardiogenic shock	12 months

Collaborators and Investigators

• Sponsor: Cardiovascular Academy Society, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Acute Coronary Syndrome; Myocardial Infarction; MINOCA
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Arrhythmias, Cardiac; Myocardial Infarction; Infarction; Syndrome; Atrial Fibrillation; Acute Coronary Syndrome
• Other Study ID Numbers: MINOCA-TR

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