ClinicalTrials.gg
Status unknownNCT04538924Updated Sep 4, 2020

Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA

An interventional study of extended clinical, laboratory and instrumental examination; treatment options comparison in Myocardial Infarction With Nonobstructive Coronary Arteries, sponsored by Vilnius University Hospital Santaros Klinikos. Status unknown at 1 site in Lithuania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Vilnius University Hospital Santaros Klinikos · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2019, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Myocardial Infarction With Nonobstructive Coronary Arteries

Browse trials for

03

In context

MINOCA

29 studies on the registry are indexed under MINOCA; 18 are open to participants now.

Browse MINOCA studies →

Lead sponsor

Vilnius University Hospital Santaros Klinikos is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion criteria

Exclusion Criteria:

  • acute kidney failure
  • stage 4-5 chronic kidney disease
  • for coronary angiography or CMR
  • patients involved in another biomedical trial
  • inability to make a decision to participate in the investigation
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Otherextended clinical, laboratory and instrumental examination; treatment options comparison

    Multimodality investigation and different treatment comparison

06

What researchers measure

Primary outcomes

  1. Rate of all-cause mortality

    Time frame: 12 months follow-up

  2. Rate of cardiovascular death

    Time frame: 12 months follow-up

Secondary outcomes

  1. Rate of hospitalization for MI

    Time frame: 12 months follow-up

  2. Rate of MACE

    Time frame: 12 months follow-up

07

Study locations

1 of 1 sites recruiting
  • Vilnius University Hospital Santaros klinikos
    Vilnius, LT-08406, Lithuania
    Recruiting
08

References and documents

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. PubMed 34562410 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04538924
Lead sponsor
Vilnius University Hospital Santaros Klinikos
Collaborators
Research Council of Lithuania
Responsible party
Rokas Šerpytis (Principal Investigator; MD, Vilnius University Hospital Santaros Klinikos) — Principal investigator
First posted
Sep 4, 2020
Start date
Jan 1, 2019
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Sep 4, 2020

Study contacts

Rokas Šerpytis
Contact
rserpytis@gmail.com
+37061089860

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion