Cardiac Structure, Function, and Clinical Manifestations in MINOCA

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Infarction, Acute Coronary Syndrome

Intervention / Treatment
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* Other: Integrative characterization of MINOCA patients
* Other: Characterization of MI patients with coronary obstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MINOCA<br>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. | Other: Integrative characterization of MINOCA patients<br>* 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.<br>|
| Active Comparator: MI with coronary obstruction<br>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. | Other: Characterization of MI patients with coronary obstruction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 3 days | 
| Frequency of atherosclerosis occurrence measure | Frequency of occurrence (%) of atherosclerosis according to multispiral computed tomography 6 days after acute coronary syndrome | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute coronary syndrome, Non-obstructive coronary artery atherosclerosis, MINOCA, Myocardial infarction, Proinflammatory interleukins, Thrombophilia, Genetic testing, SPECT, MSCT, MRI