Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA

NCT ID: NCT04538924

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-01-01

Brief Summary

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.

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).

Conditions

Myocardial Infarction With Nonobstructive Coronary Arteries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

extended clinical, laboratory and instrumental examination; treatment options comparison

Intervention Type: OTHER

Multimodality investigation and different treatment comparison

MINOCA (group II)

Treatment with a low-dose statin and ACEI/ARB. In case of vasospasm, calcium channel blockers.

Group Type: OTHER

extended clinical, laboratory and instrumental examination; treatment options comparison

Intervention Type: OTHER

Multimodality investigation and different treatment comparison

Interventions

extended clinical, laboratory and instrumental examination; treatment options comparison

Multimodality investigation and different treatment comparison

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Council of Lithuania

OTHER

Sponsor Role: collaborator

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: lead

Responsible Party

Rokas Šerpytis

Principal Investigator; MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vilnius University Hospital Santaros klinikos

Vilnius, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Rokas Šerpytis

Role: CONTACT

rserpytis@gmail.com

+37061089860

Facility Contacts

Rokas Šerpytis

Role: primary

rserpytis@gmail.com

+37061089860

References

Serpytis R, Majauskiene E, Navickas P, Lizaitis M, Glaveckaite S, Rucinskas K, Petrulioniene Z, Valeviciene N, Samalavicius RS, Berukstis A, Baranauskas A, Gargalskaite U, Laucevicius A, Chen QM, Alpert JS, Serpytis P. Randomized Pilot Trial on Optimal Treatment Strategy, Myocardial Changes, and Prognosis of Patients with Myocardial Infarction with Nonobstructive Coronary Arteries (MINOCA). Am J Med. 2022 Jan;135(1):103-109. doi: 10.1016/j.amjmed.2021.08.023. Epub 2021 Sep 22.

Reference Type: DERIVED

PMID: 34562410 (View on PubMed)

Other Identifiers

2MI-1

Identifier Type: -

Identifier Source: org_study_id