Identifying the Role of Flow Mediated Dilatation Assessment in Acute Coronary Syndromes - Evaluation of the Cor-IS Technology (the FLARE-ACS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Brachial artery endothelial function assessment using the Cor-IS method compared to FMD
研究概览
简要总结
A prospective, single-center, observational study aiming to assess the predictive role of flow mediated dilatation in acute coronary syndromes, combined with echocardiographic and biochemical indices. The novel Cor-IS technology will also be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients hospitalized due to acute coronary syndrome (STEMI, NSTEMI)
- •Capability of providing written informed consent
- •Patients able to comply with the follow-up schedule of the study
排除标准
- •Patients with acute coronary syndromes classified as MINOCA, or type II myocardial infarction
- •Patients with rare acute coronary syndrome types, such as spontaneous coronary artery dissection or Takotsubo syndrome
- •Patients with congenital heart disease
- •Age > 85 years
- •Patients with end stage chronic kidney disease
- •Patients with active malignancy or autoimmune diseases which limit their survival
- •Patients with expected survival < 1 year due to other reasons
- •Suboptimal echocardiographic windows
- •Inability to provide written consent
- •Inability to comply with the follow-up schedule of the study
- •Use of intravenous drugs
研究组 & 干预措施
Observation group
Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI)
干预措施: Observation group (Diagnostic Test)
结局指标
主要结局
Brachial artery endothelial function assessment using the Cor-IS method compared to FMD
时间窗: 12 months
The primary outcome of the study is the assessment of brachial artery endothelial function in the therapeutic approach using the Cor-IS method compared to the reference method FMD. The indices of the FMD method (FMD%, shear rate, and FMD/shear) will be compared with the R index of the Cor-IS method at the study's baseline and during follow-up.
次要结局
- FMD% index and MACE(12 months)
- R-index and need for revascularization(12 months)
- R-index and MACE(12 months)
- FMD% index and rehospitalizations for angina(12 months)
- R-index and rehospitalizations for angina(12 months)
- FMD% index and need for revascularization(12 months)
- FMD% index and heart failure(12 months)
- R-index and heart failure(12 months)