Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis

Study Overview
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Brief Summary
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The purpose of the study is to assess short and long term outcomes of acute coronary syndrome in patients with non obstructive coronary atherosclerosis, to optimize the algorithm for diagnosis and to evaluate its effectiveness

Detailed Description
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The study non randomized, opened, controlled. Cardiovascular Magnetic - resonance imaging reveals both ischemic and non-ischemic causes of acute coronary syndrome. Currently, it is the best method for Imaging and damage assessment of myocardial viability in coronary atherosclerosis and noncoronary injuries (V.Yu.Usov 2012). Taking into account the results of previous (D. Kawecki, B. Morawiec, P. Monney, 2015) research, it can be concluded that the introduction of cardiovascular magnetic resonance imaging into routine practice will change the structure of morbidity among patients with acute coronary syndrome and non obstructive coronary atherosclerosis . The research was conducted on small groups of patients, and therefore further data acquisition is required. It is planned to study 200 patients with acute coronary syndrome. On admission, they will receive the standard treatment of ACS with and without ST elevation. Within 72 hours they will performed diagnostic coronary angiography. If in case of non stenotic atherosclerosis of coronary artery (normal / stenosis < 50%) patients are planned for cardiac contrast MRI, which will identify both ischemic and non-ischemic causes of acute coronary syndrome. At 30 days, 6 months, 12 months the researchers will assess the clinical condition of the patients, perform cardiac ultrasound for the evaluation of myocardial contractile function, evaluate the incidence rate of secondary endpoints

Official Title
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Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Other: Patients with ACS
* Device: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years at time of randomization (18 years and older) acute coronary syndrome no obstructive coronary atherosclerosis (normal coronary artety/ plaques <50%) is based on the results of coronary angiography for 3 days of admission written the informed consent to participate in research Exclusion Criteria: patients previously undergone endovascular / surgical revascularization of coronary artery severe comorbidity Contacts/Locations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with ACS<br>Patients with ACS who underwent coronary angiography within 72 hours from the onset of disease. In identifying nonobstructive coronary atherosclerosis , patients underwent cardiac contrast MRI. | Other: Patients with ACS<br>* Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.<br>Device: MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue |  | 14 days after ACS | 
| Left ventricular ejection fraction (Echo) |  | 14 days after ACS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the acute myocardial infarction |  | 14 days after ACS | 
| Incidence of unstable angina |  | 14 days after ACS | 
| Incidence of Takotsubo syndrome |  | 14 days after ACS | 
| Incidence of myocarditis |  | 14 days after ACS | 
| Incidence of the mortality |  | 6 month and 12 month after ACS | 
| Incidence of the recurrent myocardial infarction |  | 6 month and 12 month after ACS | 
| Incidence of the heart failure |  | 6 month and 12 month after ACS | 
| Incidence of the stroke |  | 6 month and 12 month after ACS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, Non obstructive coronary atherosclerosis