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CompletedNCT03364387MINOCA-TRUpdated Jul 24, 2018

Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population

An observational study in Acute Coronary Syndrome, Myocardial Infarction and Atrial Fibrillation, sponsored by Cardiovascular Academy Society, Turkey. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Cardiovascular Academy Society, Turkey · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16,026
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Acute Coronary Syndrome
  • MINOCA
  • Myocardial Infarction
  • Atrial Fibrillation
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16,026 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

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

    Re-infarction, Any cause or Cardiovascular Hospitalization or Death

    Time frame: 12 months

Secondary outcomes

  1. Atrial Fibrillation

    Any type of atrial fibrillation

    Time frame: 12 months

  2. Heart failure

    Acute decompensated heart failure with or without cardiogenic shock

    Time frame: 12 months

06

Study locations

1 site
  • Emin Alioğlu
    Izmir, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03364387
Lead sponsor
Cardiovascular Academy Society, Turkey
Responsible party
Sponsor
First posted
Dec 6, 2017
Start date
Mar 5, 2018
Primary completion
May 15, 2018
Completion
Jun 15, 2018
Last update
Jul 24, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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