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Completed

NCT Number: NCT03364387

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:

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.

  • 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

Treatment and study plan

Primary outcomes

  1. Composites of Myocardial Infarction, Hospitalization, Revascularization, Death

    Time frame: 12 months

    Re-infarction, Any cause or Cardiovascular Hospitalization or Death

Secondary outcomes

  1. Atrial Fibrillation

    Time frame: 12 months

    Any type of atrial fibrillation

  2. Heart failure

    Time frame: 12 months

    Acute decompensated heart failure with or without cardiogenic shock

Sponsors and collaborators

Lead sponsor

Cardiovascular Academy Society, Turkey

Other

Registry information

Official study 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

Acronym: MINOCA-TR

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2017
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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