Acute Coronary SyndromeMINOCANCT03572023
Cardiac Structure, Function, and Clinical Manifestations in MINOCA
A study testing Integrative characterization of MINOCA patients and Characterization of MI patients with coronary obstruction in people with Acute Coronary Syndrome and Myocardial Infarction, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The purpose of this study is to improve the differential diagnosis and clinical outcomes of acute coronary syndrome with non-obstructive coronary arteries, to investigate the relationship between the structural and functional state of the heart and the clinical course of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Integrative characterization of MINOCA patients and Characterization of MI patients with coronary obstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 28 May 2018to 30 Sep 2020
- 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
- Age ≥ 18 years at time of enrolment (18 years and older)
- Patients with ACS with and without ST-segment elevation who underwent coronary angiography within 24 h after onset of the disease
- High cardiovascular risk by GRACE Risk Score
- The absence of obstructive coronary atherosclerosis (normal coronary artery / plaques <50%) is based on the results of coronary angiography
- Sinus rhythm on electrocardiogram
- Written informed consent to participate in research
Who cannot join
- Patients previously undergone endovascular / surgical revascularization of coronary artery
- Severe comorbidity
- Severe renal failure (eGFR < 30)
- Patients with cardiac pacing and claustrophobia
- Contacts / Locations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationships of Cardiac Structure and Function With Clinical Manifestation of Acute Coronary Syndrome in Patients With Non-obstructed Coronary Arteries
The purpose of this study is to improve the differential diagnosis and clinical outcomes of acute coronary syndrome with non-obstructive coronary arteries, to investigate the relationship between the structural and functional state of the heart and the clinical course of the disease.
Read the detailed description
Up to 14% of patients with acute myocardial infarction do not have obstructive changes in the coronary arteries according to invasive coronary angiography (defined as stenosis of > 50% by ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, 2017). Elevation of highly sensitive Troponin I is a marker of damage to cardiomyocytes, but it is not an underlying mechanism of myocardial damage. Forty patients with acute coronary syndrome are planned to be enrolled in the non-randomized open controlled study. On admission, patients will receive the standard treatment for ACS with and without ST elevation. Within 24 hours, they will undergo diagnostic coronary angiography. In case of nonstenotic atherosclerosis of coronary arteries (normal / stenosis < 50%), patients are planned for cardiac contrast MRI, which will identify both ischemic and non-ischemic causes of acute coronary syndrome; MSCT will be performed to study the coronary arteries and the structure of atherosclerotic plaques; scintigraphy of the myocardium will be performed to characterize the perfusion defect. The frequencies of carrying the genetic alleles associated with the factors that predispose to thrombosis will be studied. Significance of these alleles in the development of thrombosis in acute myocardial infarction will be identified. The profiles of proinflammatory and anti-inflammatory response markers will be determined. Significance of these profiles in the development of acute myocardial infarction in patients with non-obstructive coronary atherosclerosis will be determined in comparison with control group. At one-year follow up, structural and functional characteristics of the heart will be studied again to assess dynamic changes in cardiac state. At one-year follow up, repeated studies will be perform to dynamically assess the structural and functional state of the heart.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- Integrative characterization of MINOCA patients, Characterization of MI patients with coronary obstruction
- Keywords
- Acute coronary syndrome, Non-obstructive coronary artery atherosclerosis, MINOCA, Myocardial infarction, Proinflammatory interleukins, Thrombophilia, Genetic testing, SPECT, MSCT, MRI
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, MINOCA, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative characterization of MINOCA patientsOther
Characterization of MINOCA patients will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk.
MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption.
CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings.
SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability.
Blood tests.
Genetic tests.
Characterization of MI patients with coronary obstructionOther
Characterization of patients with myocardial infarction and obstructive atherosclerosis will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk.
MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption.
CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings.
SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability.
Blood tests.
Genetic tests.
| Study group | Role | What they receive |
|---|---|---|
| MINOCA | Active comparator | This group will include patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).
Integrative characterization of MINOCA patients:
The following interventions will be administered: MSCT, CMR, SPECT, Blood tests, Genetic tests. Receives: Other: Integrative characterization of MINOCA patients |
| MI with coronary obstruction | Active comparator | This group will include patients with myocardial infarction and obstructive coronary arteries.
Characterization of MI patients with coronary obstruction:
The following interventions will be administered: MSCT, CMR, SPECT, Blood tests, Genetic tests. Receives: Other: Characterization of MI patients with coronary obstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unstable plaque occurrence measure
Frequency of occurrence (%) of unstable plaques (including plaque rupture, plaque erosion, and intracoronary thrombus) according to multispiral computed tomography (MSCT) in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) 6 days after acute coronary syndrome (ACS)
Measured: 6 days
Secondary outcomes (4)
Myocardial perfusion transient defect measure
The magnitude of a transient defect (%) in myocardial perfusion in MINOCA patients in comparison with the control group of patients one week after ACS onset
Measured: 1 week
IL-6 measure
Level of proinflammatory IL-6 in blood plasma in MINOCA patients in comparison with the control group of patients with MI and stenosing arteriosclerosis one week after ACS onset
Measured: 1 week
Pro-thrombophilic allelic variant measure
The frequency of Pro-thrombophilic allelic variant (%), associated with high risk of thrombophilia, in MINOCA patients compared with control group
Measured: 3 days
Frequency of atherosclerosis occurrence measure
Frequency of occurrence (%) of atherosclerosis according to multispiral computed tomography 6 days after acute coronary syndrome
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start28 May 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vyacheslav Ryabov, MD, PhD, Study director, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572023
- Sponsor's protocol ID
- MINOCA
- Acronym
- MINOCA
- Status last verified
- Apr 2020
- First submitted
- 3 Jun 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships of Cardiac Structure and Function With Clinical Manifestation of Acute Coronary Syndrome in Patients With Non-obstructed Coronary Arteries
- ClinicalTrials.gov ID
- NCT03572023
- Acronym / sponsor ID
- MINOCA / MINOCA
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- Acute coronary syndrome, Non-obstructive coronary artery atherosclerosis, MINOCA, Myocardial infarction, Proinflammatory interleukins, Thrombophilia, Genetic testing, SPECT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 28 Jun 2018 (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.
The purpose of this study is to improve the differential diagnosis and clinical outcomes of acute coronary syndrome with non-obstructive coronary arteries, to investigate the relationship between the structural and functional state of the heart and the clinical course of the disease.
Detailed description
Up to 14% of patients with acute myocardial infarction do not have obstructive changes in the coronary arteries according to invasive coronary angiography (defined as stenosis of > 50% by ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, 2017). Elevation of highly sensitive Troponin I is a marker of damage to cardiomyocytes, but it is not an underlying mechanism of myocardial damage. Forty patients with acute coronary syndrome are planned to be enrolled in the non-randomized open controlled study. On admission, patients will receive the standard treatment for ACS with and without ST elevation. Within 24 hours, they will undergo diagnostic coronary angiography. In case of nonstenotic atherosclerosis of coronary arteries (normal / stenosis < 50%), patients are planned for cardiac contrast MRI, which will identify both ischemic and non-ischemic causes of acute coronary syndrome; MSCT will be performed to study the coronary arteries and the structure of atherosclerotic plaques; scintigraphy of the myocardium will be performed to characterize the perfusion defect. The frequencies of carrying the genetic alleles associated with the factors that predispose to thrombosis will be studied. Significance of these alleles in the development of thrombosis in acute myocardial infarction will be identified. The profiles of proinflammatory and anti-inflammatory response markers will be determined. Significance of these profiles in the development of acute myocardial infarction in patients with non-obstructive coronary atherosclerosis will be determined in comparison with control group. At one-year follow up, structural and functional characteristics of the heart will be studied again to assess dynamic changes in cardiac state. At one-year follow up, repeated studies will be perform to dynamically assess the structural and functional state of the heart.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINOCA | Active comparator | Other: Integrative characterization of MINOCA patientsThis group will include patients with myocardial infarction with non-obstructive coronary arteries (MINOCA). Integrative characterization of MINOCA patients: The following interventions will be administered: MSCT, CMR, SPECT, Blood tests, Genetic tests. |
| MI with coronary obstruction | Active comparator | Other: Characterization of MI patients with coronary obstructionThis group will include patients with myocardial infarction and obstructive coronary arteries. Characterization of MI patients with coronary obstruction: The following interventions will be administered: MSCT, CMR, SPECT, Blood tests, Genetic tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years at time of enrolment (18 years and older)
- Patients with ACS with and without ST-segment elevation who underwent coronary angiography within 24 h after onset of the disease
- High cardiovascular risk by GRACE Risk Score
- The absence of obstructive coronary atherosclerosis (normal coronary artery / plaques <50%) is based on the results of coronary angiography
- Sinus rhythm on electrocardiogram
Key exclusion criteria (5 listed)
- Patients previously undergone endovascular / surgical revascularization of coronary artery
- Severe comorbidity
- Severe renal failure (eGFR < 30)
- Patients with cardiac pacing and claustrophobia
- Contacts / Locations
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 |
|---|---|---|
| Integrative characterization of MINOCA patientsCharacterization of MINOCA patients will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk. MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption. CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings. SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability. Blood tests. Genetic tests. | Other | MINOCA |
| Characterization of MI patients with coronary obstructionCharacterization of patients with myocardial infarction and obstructive atherosclerosis will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk. MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption. CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings. SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability. Blood tests. Genetic tests. | Other | MI with coronary obstruction |
Primary outcome
Frequency of unstable plaque occurrence measure
Time frame: 6 days
Frequency of occurrence (%) of unstable plaques (including plaque rupture, plaque erosion, and intracoronary thrombus) according to multispiral computed tomography (MSCT) in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) 6 days after acute coronary syndrome (ACS)
4 secondary outcomes
Myocardial perfusion transient defect measure
Time frame: 1 week
IL-6 measure
Time frame: 1 week
Pro-thrombophilic allelic variant measure
Time frame: 3 days
Frequency of atherosclerosis occurrence measure
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
Vyacheslav Ryabov, MD, PhD study director
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative characterization of MINOCA patients and Characterization of MI patients with coronary obstruction in people with Acute Coronary Syndrome and Myocardial Infarction, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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 6 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: finished, as of the sponsor's last update on 1 Apr 2021. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of unstable plaque occurrence measure (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.