ROLE OF CIRCULATING SMALL NUCLEOLAR RNA SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
This is a prospective, non-randomized, single center, open label clinical study enrolling patients affected by 1) chronic ischemic heart disease with evidence or suspect significant myocardial ischemia (group 1, CCS) or 2) acute coronary syndromes (group 2, ACS), both undergoing coronary angiography and eventually coronary revascularization at the Department of Scienze Cardiovascolari, Diagnostica per Immagini ed Emergenze Cardiovascolari of Federico II University Hospital, Naples, Italy. Age and sex-matched healthy volunteers without known ischemic heart disease (group 3, Ctr) will also be included as a control group. At enrollment (time 0), and after 48 hours (time 48 h), 1 month (time 1mo) and 6 month-follow-up visits (time 6 mo), clinical evaluation, ECG, trans-thoracic echocardiography and blood sampling will be performed, to isolate peripheral blood mononuclear cells (PBMC) and perform standard blood tests. The enrolment phase will last 24 months, and will likely involve 450 patients distributed as follows, according to the number of patients annually referring to our University
Hospital:
- Group 1, n= 200 patients with chronic ischemic heart disease undergoing coronary angiography and eventually coronary revascularization;
- Group 2, n= 200 patients with ACS undergoing coronary angiography and eventually coronary revascularization ;
- Group 3, n= 50, healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History (> 6 months) of ischemic heart disease (prior myocardial infarction, prior percutaneous coronary intervention, prior surgical revascularization) and clinical or imaging evidence of chronic moderate or severe myocardial ischemia
- •Patients with acute coronary syndromes at presentation including ST-elevation myocardial infarction, Non-ST elevation myocardial infarction, and unstable angina.
- •Healthy volunteers with no prior history of ischemic heart disease or clinical/imaging evidence of myocardial ischemia.
排除标准
- •Patients unwilling to provide informed consent to participate to the study
- •Concomitant primary cardiomyopathies or hemodynamically significant heart valve disease
- •Treatment with cancer or antibiotic therapies affecting ribosomal structure or function.
结局指标
主要结局
Left ventricular ejection fraction
时间窗: 0, 1 month, 6 months
NT-pro-BNP levels
时间窗: 0, 1 month, 6 months
次要结局
未报告次要终点
研究者
Giovanni Esposito
Professor, Director
Federico II University
