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

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ClinicalTrials.gov Identifier: NCT03364387
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Academy Society, Turkey

November 30, 2017
December 6, 2017
July 24, 2018
March 5, 2018
May 15, 2018   (Final data collection date for primary outcome measure)
Composites of Myocardial Infarction, Hospitalization, Revascularization, Death [ Time Frame: 12 months ]
Re-infarction, Any cause or Cardiovascular Hospitalization or Death
Same as current
Complete list of historical versions of study NCT03364387 on ClinicalTrials.gov Archive Site
  • Atrial Fibrillation [ Time Frame: 12 months ]
    Any type of atrial fibrillation
  • Heart failure [ Time Frame: 12 months ]
    Acute decompensated heart failure with or without cardiogenic shock
Same as current
Not Provided
Not Provided
 
Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Fasting venous blood sample
Probability Sample

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.

  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Atrial Fibrillation
  • Diabetes Mellitus
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16026
4200
June 15, 2018
May 15, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT03364387
MINOCA-TR
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Cardiovascular Academy Society, Turkey
Cardiovascular Academy Society, Turkey
Not Provided
Not Provided
Cardiovascular Academy Society, Turkey
July 2018