RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- identify circulating transcripts codifying and not for mRNA proteins, predictive of ventricular dysfunction in patients with acute coronary artery syndrome treated with coronary angioplasty.
研究概览
简要总结
Identify circulating protein-coding (mRNAs) or non-coding (ncRNAs) transcripts (ACS_signature) predictive of ventricular dysfunction in ACS patients undergoing PCI.
详细描述
Perform an observational, prospective study involving the evaluation of circulating biomarkers predictive of ventricular dysfunction (FE <45%) in patients with ACS.
In particular, will be to verify whether there are circulating transcripts in peripheral blood, coding or not for proteins (mRNAs or ncRNAs), modulated differently in patients with ACS (ACS_signature) undergoing PCI, distinguished on the basis of evolution towards ventricular dysfunction. The study will be based on whole genome transcriptomic analysis.
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
- 否
入选标准
- •Age >18 years
- •Patients with ACS (first episode), defined according to the guidelines of the European Society of Cardiology (ESC) 2017
- •Indication for percutaneous revascularization treatment
- •Informed consent to study enrollment
排除标准
- •Severe valve disease or other conditions requiring cardiac surgery
- •Previous cardiac surgery including coronary artery bypass grafts
- •Total chronic occlusions
- •Patients with known hypersensitivity or contraindication to any of the following drugs:
- •clopidogrel,
- •ticlopidine,
- •sirolimus,
- •everolimus.
- •Any contraindication to drug-eluting stent implantation (DES)
- •Patients with a documented history of myocardial infarction;
- •Left ventricular ejection fraction (LVEF) <30% before PCI
- •Patients in cardiogenic shock
- •Patients with advanced ST-segment elevation myocardial infarction (> 48 h from onset of symptoms/Q waves on electrocardiogram) or undergoing fibrinolysis;
- •Patients with prior known cardiomyopathy with LVEF < 40%
- •Patients with malignant neoplasm or systemic disease with quoad vitam prognosis less than 1 year;
- •Patients with known active infectious diseases;
- •Patients who are unable to express valid informed consent to the act of enlistment
- •Pregnant women
结局指标
主要结局
identify circulating transcripts codifying and not for mRNA proteins, predictive of ventricular dysfunction in patients with acute coronary artery syndrome treated with coronary angioplasty.
时间窗: 1 years
For discovery activities using RNA-sequencing, based on literature data, we assume a sample size of 40 patients (20 per group) that will allow to evaluate the 40 transcripts that differentiate patients with ventricular dysfunction and not ventricular dysfunction, out of a total of 17,500 tests, with a power of 94.0 %, an FDR value of 0.02. For qPCR validation activities, a power of 95% is obtained by analyzing 50 samples per group by evaluating differences between the averages of 2,2 times, with α= 0,01 and σ= 1,4.
次要结局
- Evaluate the association of the ACS_signature with possible adverse events at 12 months and its prognostic ability in the prediction of adverse events additional to the use of standard clinical parameters.(1 years)
研究者
Luca Testa
Principal investigator
IRCCS Policlinico S. Donato