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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2018

Detailed Description

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

Interventions

  • Other: Patients with ACS
    • Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.
  • Device: MRI

Arms, Groups and Cohorts

  • Other: Patients with ACS
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
    • Time Frame: 14 days after ACS
  • Left ventricular ejection fraction (Echo)
    • Time Frame: 14 days after ACS

Secondary Measures

  • Incidence of the acute myocardial infarction
    • Time Frame: 14 days after ACS
  • Incidence of unstable angina
    • Time Frame: 14 days after ACS
  • Incidence of Takotsubo syndrome
    • Time Frame: 14 days after ACS
  • Incidence of myocarditis
    • Time Frame: 14 days after ACS
  • Incidence of the mortality
    • Time Frame: 6 month and 12 month after ACS
  • Incidence of the recurrent myocardial infarction
    • Time Frame: 6 month and 12 month after ACS
  • Incidence of the heart failure
    • Time Frame: 6 month and 12 month after ACS
  • Incidence of the stroke
    • Time Frame: 6 month and 12 month after ACS

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Russian Academy of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vyacheslav Ryabov, MD, PhD Research Institute for Cardiology – Russian Academy of Medical Sciences
  • Overall Official(s)
    • Vyacheslav Ryabov, MD,PhD, Principal Investigator, Research Institute for Cardiology
  • Overall Contact(s)
    • Vyacheslav Ryabov, MD,PhD, +73822553689, rvvt@cardio-tomsk.ru

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