NCT05091749进行中（未招募）不适用
Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- A 2AR measure
研究概览
简要总结
Transversal, national, multi-center study with progressive recruitment designed to assess the diagnostic accuracy of A2AR expression for the identification of significant obstructive CAD (FFR<0.8) of patients suspected of CCS compared to the gold standard.
- To assess the diagnostic accuracy of the A2AR profile (i.e. KD/EC50) for identifying myocardial ischemia in patients with suspected CCS compared to the gold standard inducible myocardial ischemia.
- To determine the best threshold value for A2AR expression for identifying significant obstructive CAD (FFR<0,8) in patients with CCS, and to estimate the diagnostic performances associated with the identified threshold
- To determine the best threshold value for A2AR profile (i.e. KD/EC50) for identifying myocardial ischemia (See annex 2) in patients with CCS and to estimate the diagnostic performances associated with the identified threshold.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged ≥18 and <90 years old;
- •Must not be of child-bearing potential (≥1 year post-menopausal, contraceptive, or surgically sterile);
- •Symptoms suggestive of CCS and intermediate PTP (15-85%) according to the Diamond classification (2);
- •Undergone at least one stress imaging test (annex 3) or an abnormal coronary Computed Tomography Angiography (CTA) with the recommendation to perform ICA with FFR in all intermediate lesions;
- •Non-contributive ECG (resting 18-lead);
- •Normal echocardiography with left ventricular ejection fraction (LVEF) >50%;
- •Cardiac troponin level <99th percentile;
- •Intended for an invasive strategy for CCS;
- •Affiliated to or beneficiary of, a social security system;
- •Signed written informed consent.
排除标准
- •Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
- •Pregnant, parturient or breastfeeding woman
- •Person deprived of liberty for judicial or administrative decision
- •Person under psychiatric care
- •Minor person (non-emancipated)
- •History of CAD or known CAD
- •Suspected acute coronary syndrome (ACS: annex 4)
- •Inability to undergo adenosine testing
- •Allergy to iodinated contrast media
- •Bleeding diathesis
- •Known significant bleeding risk according to physician judgment
- •Severe hepatic failure (ASAT, ALAT>3ULN)
- •Ischemic stroke within 1 month or a history of hemorrhagic stroke
- •Bradycardia
- •Platelet count <100 G/L
- •Hemoglobin <10g/dl
- •Major surgery or trauma within 10 days
- •Life expectancy <1 year
- •Pre-test Probability <15% or >85%
- •History and clinical examination suggesting non-cardiac chest pain
- •Contraindication to coronary angiography
- •Thyroid disorder
- •Refusal to participate
研究组 & 干预措施
chronic coronary syndromes
Experimental
干预措施: blood samples (Biological)
结局指标
主要结局
A 2AR measure
时间窗: 24 MONTHS
blood sample
次要结局
未报告次要终点
研究者
研究点 (1)
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