Acute Coronary SyndromeMINOCA-TRNCT03364387
Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Atrial Fibrillation
- How many people
- 16,026 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2018to 15 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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:
- Symptoms of ischaemia. ii. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
- Development of pathological Q waves in the ECG. iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Keywords
- Acute Coronary Syndrome, MINOCA, Myocardial Infarction, Atrial Fibrillation
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Atrial Fibrillation, Diabetes Mellitus, MINOCA
What is being measured
The primary outcome is the main question the study is designed to answer.
Composites of Myocardial Infarction, Hospitalization, Revascularization, Death
Re-infarction, Any cause or Cardiovascular Hospitalization or Death
Measured: 12 months
Secondary outcomes (2)
Atrial Fibrillation
Any type of atrial fibrillation
Measured: 12 months
Heart failure
Acute decompensated heart failure with or without cardiogenic shock
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start5 Mar 2018
- Primary completion15 May 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Academy Society, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364387
- Sponsor's protocol ID
- MINOCA-TR
- Acronym
- MINOCA-TR
- Status last verified
- Jul 2018
- First submitted
- 30 Nov 2017
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03364387
- Acronym / sponsor ID
- MINOCA-TR / MINOCA-TR
- Keywords
- Acute Coronary Syndrome, MINOCA, Myocardial Infarction, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,026 participants (actual)
- Lead sponsor
- Cardiovascular Academy Society, TurkeyUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composites of Myocardial Infarction, Hospitalization, Revascularization, Death
Time frame: 12 months
Re-infarction, Any cause or Cardiovascular Hospitalization or Death
2 secondary outcomes
Atrial Fibrillation
Time frame: 12 months
Heart failure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composites of Myocardial Infarction, Hospitalization, Revascularization, Death (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.