Non-invasive Evaluation of Patients With Angina and Non-obstructive Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Correlation (Phi coefficient) between TTE-induced vasoconstriction and acetylcholine-induced spasm at invasive assessment.
研究概览
简要总结
This is a single-center, prospective interventional study evaluating noninvasive coronary function testing using transthoracic Doppler echocardiography of the left anterior descending coronary artery in patients with stable angina and nonobstructive coronary artery disease (ANOCA) who previously underwent invasive coronary function testing (adenosine and/or acetylcholine).
A group of age- and sex-matched healthy volunteers will be enrolled to support interpretation of potentially abnormal noninvasive responses observed in patients.
详细描述
Patients referred to the catheterization laboratory of Fondazione Policlinico Universitario A. Gemelli IRCCS for stable angina who show non-obstructive coronary artery disease at invasive coronary angiography and underwent invasive coronary function testing will be enrolled.
During a transthoracic echocardiographic Doppler examination of the left anterior descending coronary artery, participants will undergo three standardized stimuli (hyperventilation, cold pressor test, and dipyridamole) separated by 30-minute intervals, with peak diastolic velocity measured at baseline and at the end of each test.
For each stimulus, the coronary blood flow velocity response will be expressed as the ratio between peak and basal peak diastolic velocity.
Participants will also complete the Seattle Angina Questionnaire to assess symptom burden.
The primary aim of the study is to investigate the usefulness of studying coronary flow reserve by transthoracic color Doppler echocardiogram in reaching the diagnosis of microcirculation dysfunction and/or coronary vasomotor disturbance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •Age between 18 and 90 years;
- •ICA performed within the previous 12 months from enrollment and characterized by: (a) absence of obstructive CAD (<50% diameter reduction or FFR by >0.80); (b) invasive assessment of epicardial/microvascular spasm by acetylcholine test;
- •Signed informed consent.
排除标准
- •Presentation as an acute coronary syndrome (i.e. unstable chest pain) or a typical history of variant angina (frequent angina pain at rest with ST-segment elevation at the ECG, caused by recurrent coronary spasm);
- •Previous coronary revascularization with surgical intervention;
- •Asthma or known intolerance or contraindications to dipyridamole;
- •Serious medical conditions, including renal failure (eGFR <30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
- •Psychological conditions that might hamper patient co-operation;
- •Any condition that, in the judgment of the investigators, would make difficult for the patient to complete the study protocol;
- •Missed informed consent.
研究组 & 干预措施
Non-invasive coronary flow reserve in patients with ANOCA
We will enroll patients referred to the catheterization laboratory of the Fondazione Policlinico Universitario A. Gemelli IRCCS for stable angina who showed non-obstructive coronary arteries at coronary angiography and underwent invasive coronary functional tests (adenosine and/or acetylcholine test).
干预措施: Coronary flow reserve assessed by Echocardiography (Diagnostic Test)
Non-invasive coronary flow reserve in healthy volunteers
To confirm the reliability of possible abnormal results of non-invasive coronary functional tests in angina and non-obstructive coronary arteries (ANOCA) patients, we will enroll healthy control subjects of similar age and gender of enrolled patients, selected among those referred to our ambulatory of clinical visits for a routine cardiological evaluation and undergo a screening stress test for coronary artery disease. They will undergo a dipyridamole stress echocardiogram, which is commonly used in clinical practice to investigate the presence of coronary artery disease.
干预措施: Coronary flow reserve assessed by Echocardiography (Diagnostic Test)
结局指标
主要结局
Correlation (Phi coefficient) between TTE-induced vasoconstriction and acetylcholine-induced spasm at invasive assessment.
时间窗: Periprocedural
The primary aim of the study is to investigate the usefulness of studying coronary flow reserve by transthoracic color Doppler echocardiogram in reaching the diagnosis of coronary vasomotor disturbance.
次要结局
- Agreement between dipyridamole-induced non-invasive coronary flow reserve and invasive coronary flow reserve(Periprocedural)
- Agreement between cold pressor test-induced non-invasive coronary flow reserve and invasive coronary flow reserve(Periprocedural)
- Association between abnormal non-invasive coronary vasomotor response and angina symptoms(Periprocedural)