Clinical trial NCT03572023: Cardiac Structure, Function, and Clinical Manifestations in 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Frequency of unstable plaque occurrence measure
timeFrame: 6 days
Secondary outcomes:
measure: Myocardial perfusion transient defect measure
timeFrame: 1 week
measure: IL-6 measure
timeFrame: 1 week
measure: Pro-thrombophilic allelic variant measure
timeFrame: 3 days
measure: Frequency of atherosclerosis occurrence measure
timeFrame: 6 days
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Vyacheslav Ryabov
state: Tomsk, Tomskii Region
Study officials:
affiliation: Tomsk NRMC
name: Vyacheslav Ryabov, MD, PhD
role: STUDY_DIRECTOR
References: