NCT04538924

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

4 years

First QC Date

August 27, 2020

Last Update Submit

September 3, 2020

Conditions

Myocardial Infarction With Nonobstructive Coronary Arteries

Outcome Measures

Primary Outcomes (2)

  • Rate of all-cause mortality

    12 months follow-up

  • Rate of cardiovascular death

    12 months follow-up

Secondary Outcomes (2)

  • Rate of hospitalization for MI

    12 months follow-up

  • Rate of MACE

    12 months follow-up

Study Arms (2)

MINOCA (group I) - conventional MI treatment

OTHER

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

MINOCA (group II)

OTHER

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

extended clinical, laboratory and instrumental examination; treatment options comparisonOTHER

Multimodality investigation and different treatment comparison

MINOCA (group I) - conventional MI treatmentMINOCA (group II)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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%).
  • angiography performed within 24 - 48 hours
  • age \>18 years
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Hospital Santaros klinikos

Vilnius, LT-08406, Lithuania

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34562410DERIVED

MeSH Terms

Conditions

MINOCA

Interventions

Laboratories

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private FacilitiesHealth FacilitiesHealth Care Facilities Workforce and Services

Central Study Contacts

Rokas Šerpytis

CONTACT

+37061089860rserpytis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; MD

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 4, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)