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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

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's enrollment of 16,026 is above the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Cardiovascular Academy Society, Turkey is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . 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 form to trial participation

Exclusion criteria

Exclusion Criteria:

  1. Inability/Refused to provide
  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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16,026 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

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

07

Study locations

1 site
  • Emin Alioğlu
    Izmir, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in May 2018, 2 months.

Of 243 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 2 months is below that.

Counting every sponsor, half of 277 studies reached it within 35 months; a quarter within 18 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2017
First posted
Dec 6, 2017
StartActual
Mar 5, 2018
Primary completionActual
May 15, 2018
CompletionActual
Jun 15, 2018
Last update
Jul 24, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Discussion

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