Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA

Myocardial Infarction With Nonobstructive Coronary Arteries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04538924
• Other study ID #: 2MI-1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2020
• Source: Vilnius University Hospital Santaros Klinikos
• Contact: Rokas Šerpytis
• Phone: +37061089860
• Email: rserpytis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction With Nonobstructive Coronary Arteries

Intervention

Other:
• extended clinical, laboratory and instrumental examination; treatment options comparison
Multimodality investigation and different treatment comparison

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros klinikos	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University Hospital Santaros Klinikos	Research Council of Lithuania

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause mortality		12 months follow-up
Primary	Rate of cardiovascular death		12 months follow-up
Secondary	Rate of hospitalization for MI		12 months follow-up
Secondary	Rate of MACE		12 months follow-up