Epigenetic Characterization of Angina Pectoris According to the Affected Coronary Compartment: Relationship Between Invasive Physiological Coronary Evaluation and Micro-RNAs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- FFR
研究概览
简要总结
Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). Also, biological markers will be related with presence of microvascular spasm or macrovascular spasm (Group 5).
详细描述
Patients with chest pain suggestive of angina after ruling out other cardiac and non-cardiac causes, referred for invasive coronary angiography, will be evaluated by coronary angiography and invasive coronary physiological assessment by determining FFR and IMR and by performing a vasoreactivity test with acetylcholine.
A relationship will be established between the invasive physiological assessment with FFR and IMR and biological markers such as micro-RNA's according to the affected coronary vascular compartment (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3 : Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). In addition, the biological markers will be related to the presence of microvascular spasm or macrovascular spasm (Group 5).
Finally, among other biological markers, the following miRNAs will be compared. These miRNA's present consistent data in the literature about their over or underexpression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention.
- •Echocardiogram ruling out noncoronary cardiac causes of chest pain.
- •Informed consent.
排除标准
- •Contrast allergy not susceptible to premedication.
- •Severe bronchial asthma or adenosine intolerance.
- •Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.
- •Acute myocardial infarction with ST-segment elevation.
- •Acute myocardial infarction without ST-segment elevation.
- •Cardiogenic shock.
- •Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires.
- •Previous coronary artery bypass grafting.
- •Women with the possibility of being pregnant.
- •Renal dysfunction with an estimated glomerular filtration rate <30 mL/min/1.73m
- •Inability to understand the nature of the study and / or sign informed consent.
- •Any other medical condition that, in the opinion of the researcher, may lead to safety issues for patients or may alter the results of the study.
结局指标
主要结局
FFR
时间窗: Intraprocedure
Fractional flow reserve
IMR
时间窗: Intraprocedure
Index of microvascular resistance
Ach
时间窗: Intraprocedure
Acetilcholine test
次要结局
- QCA(Intraprocedure)
研究者
Diego Fernández-Rodríguez
Principal Investigator
Hospital Arnau de Vilanova