Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA

September 3, 2020 updated by: Rokas Šerpytis, Vilnius University Hospital Santaros Klinikos

Multimodality Study on Etiologic Mechanisms, Myocardial Changes, and Prognosis of Patients With Myocardial Infarction With Non-obstructive Coronary Arteries

This prospective trial will include 150 patients with myocardial infarction with non-obstructive coronary arteries (MINOCA). A thorough clinical, laboratory and imaging evaluation will be performed by novel biomarkers and modern imaging techniques (heart magnetic resonance imaging and noninvasive testing). Moreover, two different treatment groups will be distinguished. Additionally, a retrospective analysis of patients meeting MINOCA criteria will be performed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary goals The primary trial goal is to assess the etiologic mechanisms of myocardial damage in patients with MINOCA as well as to evaluate a variety of therapeutic strategies for these patients.

Secondary goals

  1. To assess functional and morphological myocardial changes in patients with MINOCA;
  2. To assess the true prevalence and prognostic relevance of MINOCA (all-cause mortality and MACE);
  3. To test the effect of conventional acute MI therapies (BB, ACEI, ARB, CCB, statins, anti-platelet agents) on MACE (death and myocardial infarction) and all-cause mortality in patients with MINOCA;
  4. To test the diagnostic and prognostic role of several biomarkers (sST2, BNP, cTnI, CRP, copeptin, procalcitonin, MR-proADM, galectin-3) in patients with MINOCA;
  5. To assess the impact of MINOCA with respect to chronic health status, such as persistent angina symptoms, impairment in quality of life, and depression;
  6. To evaluate systemic microcirculation status and assess its effect on long term outcomes.
  7. To evaluate hospital mortality and all-cause death within 6 and 12 months follow-up;
  8. To determine recurrent hospitalizations within 30-days, 6 and 12 months follow-up;
  9. To assess peak creatine kinase, creatine kinase-MB and troponin levels during hospital stay;
  10. To determine quality of life at 6 and 12 months assessed using the Euroqol 5D (EQ-5D) questionnaire (www.euroqol.org).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, LT-08406
        • Recruiting
        • Vilnius University hospital Santaros klinikos
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. acute MI:

    • detection of a rise and/or fall of cardiac troponin(cTn) values with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
    • symptoms of acute myocardial ischaemia;
    • new ischaemic ECG changes;
    • development of pathological Q waves;
    • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology

  2. non-obstructive coronary arteries on angiography:

    - the absence of obstructive coronary artery disease (CAD) on angiography, (i.e. no coronary artery stenosis ≥50%), in any potential infarct-related artery;

    This includes both patients with:

    • normal or near normal coronary arteries (no stenosis >30%)
    • mild coronary atheromatosis (stenosis >30% but <50%).
  3. angiography performed within 24 - 48 hours
  4. age >18 years
  5. informed consent

Exclusion Criteria:

  • acute kidney failure
  • stage 4-5 chronic kidney disease
  • contraindications for coronary angiography or CMR
  • patients involved in another biomedical trial
  • inability to make a decision to participate in the investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MINOCA (group I) - conventional MI treatment
Traditional MI treatment with optimal doses of statin, angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB), beta-blockers (BB) and dual antiplatelet therapy (DAPT).
Other: extended clinical, laboratory and instrumental examination; treatment options comparison
Multimodality investigation and different treatment comparison
Other: MINOCA (group II)
Treatment with a low-dose statin and ACEI/ARB. In case of vasospasm, calcium channel blockers.
Other: extended clinical, laboratory and instrumental examination; treatment options comparison
Multimodality investigation and different treatment comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of all-cause mortality
Time Frame: 12 months follow-up
12 months follow-up
Rate of cardiovascular death
Time Frame: 12 months follow-up
12 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of hospitalization for MI
Time Frame: 12 months follow-up
12 months follow-up
Rate of MACE
Time Frame: 12 months follow-up
12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University Hospital Santaros Klinikos

Collaborators

Research Council of Lithuania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2MI-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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