The Impact of Hyperemic State on the Performance of Angiography Derived Indices in Assessing Coronary Microvascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 2
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic performance of angiography-derived microcirculatory indices (Angio-IMR) in assessing patients with stable angina or suspected coronary artery disease. The main questions it aims to answer are:
How do the numerical values of Angio-IMR from five different software vendors change across three physiological states (resting, sub-hyperemia induced by nitroglycerin, and maximal hyperemia induced by adenosine)? Which physiological state and software algorithm provide the highest diagnostic accuracy (Area Under the Curve, AUC) for diagnosing Coronary Microvascular Disease (CMD) when compared to the gold standard wire-based IMR? Researchers will compare the Angio-IMR results calculated under the three different physiological conditions within the same patient to see how the hyperemic state impacts the performance and consistency of these non-invasive indices.
Participants will:
Undergo standard-of-care coronary angiography and physiological assessment using a pressure wire for index of microvascular resistance (Wire-IMR) as part of their clinical management.
Have their angiographic images captured at three specific time points: at rest, after intracoronary nitroglycerin, and during adenosine-induced maximal hyperemia.
Allow their de-identified imaging and clinical data to be analyzed by an independent core laboratory using five different Angio-IMR software platforms to evaluate microvascular function.
详细描述
Study Overview and Procedural Protocol
This is a prospective, multi-center, diagnostic accuracy study employing a self-controlled design. All participants will undergo coronary angiography and physiological assessment according to standard clinical indications. During the procedure, specific angiographic images will be systematically captured for the target vessel at three distinct physiological time points:
Resting State: Baseline coronary angiography without any hyperemic agents. Sub-hyperemic State: Following the intracoronary administration of nitroglycerin.
Maximal Hyperemic State: During continuous intracoronary infusion of adenosine to achieve maximal microvascular vasodilation.
Immediately following image acquisition, the reference standard measurement-Wire-IMR-will be performed using a pressure-sensor-equipped guidewire under maximal hyperemia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina or suspected coronary heart disease.
- •Scheduled for coronary angiography and physiological assessment.
- •Target vessel with stenosis < 50% or 50%-90% with fractional flow reserve (FFR) > 0.
- •Provided informed consent.
排除标准
- •Hemodynamic instability (acute myocardial infarction, cardiogenic shock, severe arrhythmia).
- •Contraindications to angiography (e.g., end-stage renal disease).
- •Contraindications to adenosine (e.g., severe asthma, high-degree atrial-ventricular block).
- •Life expectancy < 1 year or pregnancy.
- •Target vessel unsuitable for wire operation (left main lesion, severe tortuosity) or stenosis > 90%.
研究者
Junbo Ge
Director of Department of Cardiology
Shanghai Zhongshan Hospital