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

Primary Purpose

Acute Coronary Syndrome, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Integrative characterization of MINOCA patients
Characterization of MI patients with coronary obstruction
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Non-obstructive coronary artery atherosclerosis, MINOCA, Myocardial infarction, Proinflammatory interleukins, Thrombophilia, Genetic testing, SPECT, MSCT, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vyacheslav Ryabov

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MINOCA

MI with coronary obstruction

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
Frequency of atherosclerosis occurrence measure
Frequency of occurrence (%) of atherosclerosis according to multispiral computed tomography 6 days after acute coronary syndrome

Full Information

First Posted
June 3, 2018
Last Updated
March 30, 2021
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03572023
Brief Title
Cardiac Structure, Function, and Clinical Manifestations in MINOCA
Acronym
MINOCA
Official Title
Relationships of Cardiac Structure and Function With Clinical Manifestation of Acute Coronary Syndrome in Patients With Non-obstructed Coronary Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Myocardial Infarction
Keywords
Acute coronary syndrome, Non-obstructive coronary artery atherosclerosis, MINOCA, Myocardial infarction, Proinflammatory interleukins, Thrombophilia, Genetic testing, SPECT, MSCT, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MINOCA
Arm Type
Active Comparator
Arm 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.
Arm Title
MI with coronary obstruction
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Integrative characterization of MINOCA patients
Intervention Description
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
Intervention Name(s)
Characterization of MI patients with coronary obstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of unstable plaque occurrence measure
Description
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)
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Myocardial perfusion transient defect measure
Description
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
Time Frame
1 week
Title
IL-6 measure
Description
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
Time Frame
1 week
Title
Pro-thrombophilic allelic variant measure
Description
The frequency of Pro-thrombophilic allelic variant (%), associated with high risk of thrombophilia, in MINOCA patients compared with control group
Time Frame
3 days
Title
Frequency of atherosclerosis occurrence measure
Description
Frequency of occurrence (%) of atherosclerosis according to multispiral computed tomography 6 days after acute coronary syndrome
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD, PhD
Organizational Affiliation
Tomsk NRMC
Official's Role
Study Director
Facility Information:
Facility Name
Vyacheslav Ryabov
City
Tomsk
State/Province
Tomsk, Tomskii Region
ZIP/Postal Code
634012
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Cardiac Structure, Function, and Clinical Manifestations in MINOCA

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