Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population

Atrial Fibrillation Clinical Trial

— MINOCA-TR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364387
• Other study ID #: MINOCA-TR
• Status: Completed
• Start date: March 5, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: July 2018
• Source: Cardiovascular Academy Society, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16026
• Est. completion date: June 15, 2018
• Est. primary completion date: May 15, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 signi?cant 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. Identi?cation 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atrial Fibrillation
• Diabetes Mellitus
• Infarction
• Myocardial Infarction
• Syndrome

Locations

Country	Name	City	State
Turkey	Emin Alioglu	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular Academy Society, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composites of Myocardial Infarction, Hospitalization, Revascularization, Death	Re-infarction, Any cause or Cardiovascular Hospitalization or Death	12 months
Secondary	Atrial Fibrillation	Any type of atrial fibrillation	12 months
Secondary	Heart failure	Acute decompensated heart failure with or without cardiogenic shock	12 months