Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA

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: Myocardial Infarction With Nonobstructive Coronary Arteries
• Intervention / Treatment: Other: extended clinical, laboratory and instrumental examination; treatment options comparison

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

Study Locations

• Lithuania
  • Vilnius, Lithuania, LT-08406
    • Recruiting
    • Vilnius University Hospital Santaros Klinikos
    • Contact: Rokas Šerpytis; Phone Number: +37061089860; Email: rserpytis@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	12 months follow-up
Rate of cardiovascular death	12 months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vilnius University Hospital Santaros Klinikos
• Collaborators: Research Council of Lithuania

Publications and helpful links

General Publications

• 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.

Study record dates

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: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• 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