Myocardial Infarction With Nonobstructive Coronary ArteriesNCT04538924
Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA
A study testing extended clinical, laboratory and instrumental examination; treatment options comparison in people with Myocardial Infarction With Nonobstructive Coronary Arteries, run by Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction With Nonobstructive Coronary Arteries
- What is being tested?
- extended clinical, laboratory and instrumental examination; treatment options comparison
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jan 2019to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros klinikos
Vilnius, LT-08406
Rokas Šerpytis, +37061089860, rserpytis@gmail.com
About this study
Official title: 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.
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
- To assess functional and morphological myocardial changes in patients with MINOCA;
- To assess the true prevalence and prognostic relevance of MINOCA (all-cause mortality and MACE);
- 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;
- To test the diagnostic and prognostic role of several biomarkers (sST2, BNP, cTnI, CRP, copeptin, procalcitonin, MR-proADM, galectin-3) in patients with MINOCA;
- To assess the impact of MINOCA with respect to chronic health status, such as persistent angina symptoms, impairment in quality of life, and depression;
- To evaluate systemic microcirculation status and assess its effect on long term outcomes.
- To evaluate hospital mortality and all-cause death within 6 and 12 months follow-up;
- To determine recurrent hospitalizations within 30-days, 6 and 12 months follow-up;
- To assess peak creatine kinase, creatine kinase-MB and troponin levels during hospital stay;
- To determine quality of life at 6 and 12 months assessed using the Euroqol 5D (EQ-5D) questionnaire (www.euroqol.org).
- Being tested
- extended clinical, laboratory and instrumental examination; treatment options comparison
- Medical subject headings
- MINOCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended clinical, laboratory and instrumental examination; treatment options comparisonOther
Multimodality investigation and different treatment comparison
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: extended clinical, laboratory and instrumental examination; treatment options comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality
Measured: 12 months follow-up
Rate of cardiovascular death
Measured: 12 months follow-up
Secondary outcomes (2)
Rate of hospitalization for MI
Measured: 12 months follow-up
Rate of MACE
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction With Nonobstructive Coronary ArteriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Collaborators
- Research Council of Lithuania
- Responsible party
- Principal investigator, Rokas Šerpytis, Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538924
- Sponsor's protocol ID
- 2MI-1
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Study on Etiologic Mechanisms, Myocardial Changes, and Prognosis of Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
- ClinicalTrials.gov ID
- NCT04538924
- Acronym / sponsor ID
- 2MI-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Collaborators
- Research Council of Lithuania
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To assess functional and morphological myocardial changes in patients with MINOCA;
- To assess the true prevalence and prognostic relevance of MINOCA (all-cause mortality and MACE);
- 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;
- To test the diagnostic and prognostic role of several biomarkers (sST2, BNP, cTnI, CRP, copeptin, procalcitonin, MR-proADM, galectin-3) in patients with MINOCA;
- To assess the impact of MINOCA with respect to chronic health status, such as persistent angina symptoms, impairment in quality of life, and depression;
- To evaluate systemic microcirculation status and assess its effect on long term outcomes.
- To evaluate hospital mortality and all-cause death within 6 and 12 months follow-up;
- To determine recurrent hospitalizations within 30-days, 6 and 12 months follow-up;
- To assess peak creatine kinase, creatine kinase-MB and troponin levels during hospital stay;
- To determine quality of life at 6 and 12 months assessed using the Euroqol 5D (EQ-5D) questionnaire (www.euroqol.org).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINOCA (group I) - conventional MI treatment | Other | Other: extended clinical, laboratory and instrumental examination; treatment options comparisonTraditional 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). |
| MINOCA (group II) | Other | Other: extended clinical, laboratory and instrumental examination; treatment options comparisonTreatment with a low-dose statin and ACEI/ARB. In case of vasospasm, calcium channel blockers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- acute MI:
- non-obstructive coronary arteries on angiography:
- angiography performed within 24 - 48 hours
- age >18 years
- informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended clinical, laboratory and instrumental examination; treatment options comparisonMultimodality investigation and different treatment comparison | Other | MINOCA (group I) - conventional MI treatment, MINOCA (group II) |
Primary outcome
Rate of all-cause mortality
Time frame: 12 months follow-up
Rate of cardiovascular death
Time frame: 12 months follow-up
2 secondary outcomes
Rate of hospitalization for MI
Time frame: 12 months follow-up
Rate of MACE
Time frame: 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Derived from this study: PubMed 34562410Serpytis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extended clinical, laboratory and instrumental examination; treatment options comparison in people with Myocardial Infarction With Nonobstructive Coronary Arteries, run by Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rokas Šerpytis (+37061089860, rserpytis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause mortality (time frame: 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.