Cardiac Structure, Function, and Clinical Manifestations in MINOCA

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Treatments: Other: Integrative characterization of MINOCA patients; Other: Characterization of MI patients with coronary obstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03572023

MINOCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

MINOCA

Active Comparator group

Description:

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.

Treatment:

Other: Integrative characterization of MINOCA patients

MI with coronary obstruction

Active Comparator group

Description:

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.

Treatment:

Other: Characterization of MI patients with coronary obstruction