Cardiac Structure, Function, and Clinical Manifestations in MINOCA

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome; Myocardial Infarction
• Interventions: Other: Integrative characterization of MINOCA patients; Other: Characterization of MI patients with coronary obstruction

• Registration Number: NCT03572023
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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.

Study Timeline

• Study Start: 2018-05-28
• Study First Submitted: 2018-06-03
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-28
• Status Verified: 2020-04
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MINOCA	Integrative characterization of MINOCA patients	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.
MI with coronary obstruction	Characterization of MI patients with coronary obstruction	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.

Primary Outcome Measures

Name	Time	Method
Frequency of unstable plaque occurrence measure	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)

Secondary Outcome Measures

Name	Time	Method
Pro-thrombophilic allelic variant measure	3 days	The frequency of Pro-thrombophilic allelic variant (%), associated with high risk of thrombophilia, in MINOCA patients compared with control group
Myocardial perfusion transient defect measure	1 week	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
Frequency of atherosclerosis occurrence measure	6 days	Frequency of occurrence (%) of atherosclerosis according to multispiral computed tomography 6 days after acute coronary syndrome
IL-6 measure	1 week	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

Trial Locations

Locations (1)

Vyacheslav Ryabov; 🇷🇺 Tomsk, Tomsk, Tomskii Region, Russian Federation