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Cardiac Structure, Function, and Clinical Manifestations in MINOCA

Relationships of Cardiac Structure and Function With Clinical Manifestation of Acute Coronary Syndrome in Patients With Non-obstructed Coronary Arteries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572023
Acronym
MINOCA
Enrollment
80
Registered
2018-06-28
Start date
2018-05-28
Completion date
2020-09-30
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Myocardial Infarction

Keywords

Acute coronary syndrome, Non-obstructive coronary artery atherosclerosis, MINOCA, Myocardial infarction, Proinflammatory interleukins, Thrombophilia, Genetic testing, SPECT, MSCT, MRI

Brief 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.

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.

Interventions

OTHERIntegrative characterization of MINOCA patients

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.

OTHERCharacterization of MI patients with coronary obstruction

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.

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients previously undergone endovascular / surgical revascularization of coronary artery * Severe comorbidity * Severe renal failure (eGFR \< 30) * Patients with cardiac pacing and claustrophobia * Contacts / Locations

Design outcomes

Primary

MeasureTime frameDescription
Frequency of unstable plaque occurrence measure6 daysFrequency 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)

Secondary

MeasureTime frameDescription
Myocardial perfusion transient defect measure1 weekThe magnitude of a transient defect (%) in myocardial perfusion in MINOCA patients in comparison with the control group of patients one week after ACS onset
IL-6 measure1 weekLevel 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
Pro-thrombophilic allelic variant measure3 daysThe frequency of Pro-thrombophilic allelic variant (%), associated with high risk of thrombophilia, in MINOCA patients compared with control group
Frequency of atherosclerosis occurrence measure6 daysFrequency of occurrence (%) of atherosclerosis according to multispiral computed tomography 6 days after acute coronary syndrome

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026