Non-Invasive Coronary Functional Evaluation of Patients With Single-vessel Coronary Artery Disease Treated With Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Difference in coronary flow reserve (CFR) between the LAD and non-LAD groups
研究概览
简要总结
Persistent or recurrent angina after successful percutaneous coronary intervention (PCI) remains a common clinical problem, affecting approximately 20-30% of patients despite complete epicardial coronary revascularization. Coronary microvascular dysfunction (CMD) has been proposed as a potential mechanism underlying persistent symptoms and abnormal functional testing after PCI, but it is still unclear whether CMD develops as a consequence of the PCI procedure or represents a pre-existing condition associated with coronary artery disease.
The NICE-CAD-PCI study is a prospective, single-center study designed to investigate coronary microvascular function in patients with stable single-vessel coronary artery disease treated with PCI. Specifically, the study will compare coronary microvascular function in the left anterior descending coronary artery (LAD) territory between patients undergoing PCI of the LAD and patients undergoing PCI of a different coronary artery (right coronary artery or left circumflex artery). This approach aims to clarify whether impaired coronary microvascular function is limited to the treated vascular territory, suggesting a PCI-related effect, or is also present in non-treated territories, supporting the hypothesis of a pre-existing generalized microvascular abnormality.
Within four weeks after PCI, all participants will undergo a comprehensive non-invasive coronary functional evaluation using transthoracic Doppler echocardiography (TTDE) to assess coronary blood flow velocity in the LAD during hyperventilation, cold pressor, and dipyridamole stress tests. Coronary flow reserve and coronary flow responses to the different physiological stimuli will be evaluated as markers of coronary vascular function.
Participants will be followed for six months after PCI to assess the occurrence of clinically driven target lesion revascularization and major adverse cardiovascular events. The study will also explore whether abnormalities detected by non-invasive coronary functional testing are associated with restenosis or adverse clinical outcomes.
The findings of this study may improve the understanding of the mechanisms responsible for persistent symptoms after PCI and contribute to the identification of patients with coronary microvascular dysfunction who may benefit from tailored diagnostic and therapeutic strategies.
详细描述
Within four weeks after PCI, all enrolled patients will undergo a comprehensive non-invasive coronary functional evaluation using transthoracic Doppler echocardiography (TTDE). After a 10-minute resting period, a complete baseline echocardiographic examination will be performed, including assessment of global and regional left ventricular wall motion. The mid-distal left anterior descending coronary artery (LAD) will then be identified by color Doppler imaging, and peak diastolic coronary blood flow velocity (CBFV) will be measured using pulsed-wave Doppler.
Coronary vascular function will subsequently be assessed using three sequential coronary functional tests performed under continuous 12-lead electrocardiographic monitoring, intermittent blood pressure measurements, and peripheral oxygen saturation monitoring, with a 15-minute recovery interval between tests.
The hyperventilation test will be performed by asking participants to breathe deeply and rapidly at a rate of approximately 30 breaths per minute for 5 minutes. The cold pressor test will consist of immersion of the participant's right hand in ice water for 2 minutes. Finally, dipyridamole will be administered intravenously at a dose of 0.84 mg/kg over 6 minutes to assess endothelium-independent coronary vasodilator capacity.
Coronary blood flow velocity will be measured at baseline and at the peak of each functional test. The ratio between peak and baseline CBFV will be calculated for each stimulus as an index of coronary vascular function. Symptoms, electrocardiographic changes, and inducible regional wall motion abnormalities will also be recorded throughout the examination. Patients receiving beta-blockers or calcium channel blockers will be asked to temporarily discontinue these medications for 48 hours before the study examination.
The primary endpoint is the comparison of coronary flow reserve measured during dipyridamole stress between the LAD and non-LAD groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Invasive coronary angiography and PCI performed within the previous 4 weeks from enrollment;
- •Obstructive single-vessel CAD (>75% coronary diameter reduction or fractional flow reserve <0.80) treated with PCI.
排除标准
- •Presentation as an acute coronary syndrome (i.e. unstable angina or myocardial infarction) 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 history of specific heart disease, e.g., ischemic (previous percutaneous or surgical myocardial revascularization, myocardial infarction), valvular, congenital heart disease or cardiomyopathy;
- •Multivessel coronary artery disease;
- •Serious medical conditions, including renal failure (eGFR <30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
- •Contraindication to dipyridamole;
- •Pregnancy;
- •Psychological conditions that might interfere with patient co-operation;
- •Any condition that, in the judgment of the investigators, would make difficult for the patient to complete the study protocol;
- •Refusal to sign the informed consent.
研究组 & 干预措施
LAD group
Patients with stable single-vessel coronary artery disease who underwent successful percutaneous coronary intervention (PCI) of the left anterior descending coronary artery. All participants undergo non-invasive coronary functional assessment by transthoracic Doppler echocardiography within 4 weeks after PCI and 6-month clinical follow-up.
干预措施: Coronary flow reserve assessed by Echocardiography (Diagnostic Test)
Non-LAD group
Patients with stable single-vessel coronary artery disease who underwent successful percutaneous coronary intervention (PCI) of the right coronary artery or left circumflex artery. All participants undergo non-invasive coronary functional assessment by transthoracic Doppler echocardiography within 4 weeks after PCI and 6-month clinical follow-up.
干预措施: Coronary flow reserve assessed by Echocardiography (Diagnostic Test)
结局指标
主要结局
Difference in coronary flow reserve (CFR) between the LAD and non-LAD groups
时间窗: Duration of the procedure
Coronary flow reserve (CFR) will be measured by transthoracic Doppler echocardiography (TTDE) in the left anterior descending coronary artery during dipyridamole administration. CFR will be calculated as the ratio between peak hyperemic and baseline diastolic coronary blood flow velocity. Mean CFR values will be compared between patients undergoing PCI of the LAD (LAD group) and patients undergoing PCI of a non-LAD coronary artery (non-LAD group). CFR is a dimensionless ratio.
次要结局
- Incidence of major adverse cardiovascular events (MACE) according to the presence of functional coronary abnormalities(6-months after the enrollment.)