Cardiac Structure, Function, and Clinical Manifestations in MINOCA (MINOCA)

March 30, 2021 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Tomsk, Tomskii Region
      • Tomsk, Tomsk, Tomskii Region, Russian Federation, 634012
        • Vyacheslav Ryabov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of unstable plaque occurrence measure
Time Frame: 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)
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial perfusion transient defect measure
Time Frame: 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
1 week
IL-6 measure
Time Frame: 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
1 week
Pro-thrombophilic allelic variant measure
Time Frame: 3 days
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
Time Frame: 6 days
Frequency of occurrence (%) of atherosclerosis according to multispiral computed tomography 6 days after acute coronary syndrome
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Study Director: Vyacheslav Ryabov, MD, PhD, Tomsk NRMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

June 3, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MINOCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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