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Clinical Trials/NCT03364387
NCT03364387
Completed
Not Applicable

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

Cardiovascular Academy Society, Turkey1 site in 1 country16,026 target enrollmentMarch 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Cardiovascular Academy Society, Turkey
Enrollment
16026
Locations
1
Primary Endpoint
Composites of Myocardial Infarction, Hospitalization, Revascularization, Death
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 5, 2018
End Date
June 15, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Cardiovascular Academy Society, Turkey
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Composites of Myocardial Infarction, Hospitalization, Revascularization, Death

Time Frame: 12 months

Re-infarction, Any cause or Cardiovascular Hospitalization or Death

Secondary Outcomes

  • Atrial Fibrillation(12 months)
  • Heart failure(12 months)

Study Sites (1)

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