Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction (Echo)
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patients previously undergone endovascular / surgical revascularization of coronary artery
- •severe comorbidity
- •Contacts/Locations
研究组 & 干预措施
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.
干预措施: MRI (Device)
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.
干预措施: Patients with ACS (Other)
结局指标
主要结局
Left ventricular ejection fraction (Echo)
时间窗: 14 days after ACS
Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue
时间窗: 14 days after ACS
次要结局
- Incidence of the stroke(6 month and 12 month after ACS)
- 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 heart failure(6 month and 12 month 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)
研究者
Vyacheslav Ryabov
MD, PhD Research Institute for Cardiology
Russian Academy of Medical Sciences