ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease
Acute Coronary Syndrome Myocardial Infarction Atrial Fibrillation Diabetes Mellitus

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
Actual Enrollment : 16026 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack




Primary Outcome Measures :
  1. Composites of Myocardial Infarction, Hospitalization, Revascularization, Death [ Time Frame: 12 months ]
    Re-infarction, Any cause or Cardiovascular Hospitalization or Death


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Fasting venous blood sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364387


Locations
Turkey
Emin Alioğlu
Izmir, Turkey
Sponsors and Collaborators
Cardiovascular Academy Society, Turkey

Responsible Party: Cardiovascular Academy Society, Turkey
ClinicalTrials.gov Identifier: NCT03364387     History of Changes
Other Study ID Numbers: MINOCA-TR
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cardiovascular Academy Society, Turkey:
Acute Coronary Syndrome
MINOCA
Myocardial Infarction
Atrial Fibrillation

Additional relevant MeSH terms:
Syndrome
Diabetes Mellitus
Atrial Fibrillation
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases