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Clinical Trials/NCT03572023
NCT03572023
Completed
Not Applicable

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

Tomsk National Research Medical Center of the Russian Academy of Sciences1 site in 1 country80 target enrollmentMay 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Enrollment
80
Locations
1
Primary Endpoint
Frequency of unstable plaque occurrence measure
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 28, 2018
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Myocardial perfusion transient defect measure(1 week)
  • Frequency of atherosclerosis occurrence measure(6 days)
  • IL-6 measure(1 week)
  • Pro-thrombophilic allelic variant measure(3 days)

Study Sites (1)

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