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临床试验/NCT06678802
NCT06678802招募中不适用

ROLE OF CIRCULATING SMALL NUCLEOLAR RNA SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE

Federico II University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2024年3月1日最近更新:
适应症

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:

  1. Group 1, n= 200 patients with chronic ischemic heart disease undergoing coronary angiography and eventually coronary revascularization;
  2. Group 2, n= 200 patients with ACS undergoing coronary angiography and eventually coronary revascularization ;
  3. 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

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

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Esposito

Professor, Director

Federico II University

研究点 (1)

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