Cardiac Structure, Function, and Clinical Manifestations in MINOCA

NCT ID: NCT03572023

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-28
• Study Completion Date: 2020-09-30

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MINOCA

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.

Group Type: ACTIVE_COMPARATOR

Integrative characterization of MINOCA patients

Intervention Type: OTHER

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.

MI 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.

Group Type: ACTIVE_COMPARATOR

Characterization of MI patients with coronary obstruction

Intervention Type: OTHER

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.

Interventions

Integrative 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.

Intervention Type: OTHER

Characterization 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vyacheslav Ryabov, MD, PhD

Role: STUDY_DIRECTOR

Tomsk NRMC

Locations

Vyacheslav Ryabov

Tomsk, Tomsk, Tomskii Region, Russia

Countries

Russia

Other Identifiers

MINOCA

Identifier Type: -

Identifier Source: org_study_id