Cardioneuroablation of Atrial Ganglionated Plexi in Patients With Variant Angina
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Heart Rate Variability (HRV) Changes
研究概览
简要总结
Variant angina, also known as vasospastic angina, is a form of chest pain caused by temporary spasms of the coronary arteries, which reduce blood flow to the heart. These spasms often occur at rest and may lead to serious complications, including life-threatening heart rhythm problems and sudden cardiac death. While most patients improve with medications such as calcium channel blockers and nitrates, some continue to have symptoms despite treatment. In addition, some patients are unable or unwilling to take medications regularly, which further limits effective management. These cases are referred to as medication-refractory or drug-intolerant variant angina.
The autonomic nervous system, which controls involuntary functions like heart rate and blood vessel tone, is believed to play an important role in the development of coronary artery spasms. Recent research suggests that imbalances in autonomic activity, particularly excessive parasympathetic signals, may trigger these spasms.
Cardioneuroablation (CNA) is a minimally invasive procedure that uses a catheter to target specific nerve clusters called cardiac ganglionated plexi, located on the surface of the heart. These plexi are important centers of autonomic control and are mostly made up of parasympathetic nerve cells. Originally developed to treat conditions such as fainting spells and certain types of abnormal heart rhythms, CNA works by selectively reducing abnormal parasympathetic activity in the heart.
This study is designed to explore whether CNA can help relieve chest pain and reduce coronary spasms in patients with variant angina who do not respond to medications or cannot take them consistently. The study will evaluate the safety, practicality, and potential benefits of this approach as a new treatment option for a difficult-to-manage heart condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years;
- •variant angina;
- •positive ergonovine provocation test;
- •refractory to antispasmodic drug therapy, or inability to achieve adequate symptom control due to drug intolerance, poor adherence, or unwillingness to take medications regularly.
排除标准
- •cardiogenic shock;
- •chronic heart failure;
- •life expectancy less than 12 months;
- •current participation in another clinical study without completing the primary endpoint visit; inability to provide informed consent;
- •women of childbearing potential without effective contraception or who are breastfeeding;
- •coronary artery stenosis ≥50% or FFR ≤0.80;
- •sick sinus syndrome or high-degree AV block without pacemaker;
- •systolic blood pressure <90mmHg or heart rate <50 bpm;
- •allergy to diltiazem, nitrates, or nitroglycerin.
结局指标
主要结局
Heart Rate Variability (HRV) Changes
时间窗: Baseline and 1, 3, and 6 months post-treatment
HRV parameters will be analyzed from 24-hour Holter ECG to assess autonomic modulation following ablation.
Requirement for Anti-Anginal Medications
时间窗: Baseline and up to 6 months post-procedure
Dosage and frequency of anti-anginal drug use will be recorded to assess dependence on medication after CNA.
Change in Frequency of Coronary Spasm Episodes
时间窗: Baseline and up to 6 months post-procedure
The number of coronary spasm episodes will be recorded before and after the procedure using 24-hour Holter ECG and integrated dynamic ECG device. Reduction in episode frequency will be used to evaluate treatment efficacy.
Change in Angina Attack Frequency
时间窗: Baseline and up to 6 months after treatment
The frequency of chest pain episodes will be assessed through patient diaries and clinical interviews to evaluate symptom relief after treatment.
Severity of Coronary Spasms
时间窗: Baseline and up to 6 months post-procedure
Severity will be assessed using imaging findings and clinical scoring systems, such as the Canadian Cardiovascular Society (CCS) Angina Grading Scale, to compare pre- and post-procedural status. CCS Angina Grading Scale ranges from Class I (least severe) to Class IV (most severe), with higher scores indicating worse angina severity. Additional imaging-based assessments (e.g., degree of coronary artery narrowing on angiography) will be qualitatively or semi-quantitatively described.
Electrocardiographic Changes
时间窗: Baseline and up to 6 months
Standard 12-lead ECGs and 24-hour Holter monitoring will be analyzed for changes in ST-segment shifts and arrhythmias before and after the procedure.
Major Adverse Cardiovascular Events
时间窗: From procedure until 6 months post-procedure
Incidence of cardiovascular events including arrhythmia, cardiac arrest, cardiac death, and acute myocardial infarction will be recorded during follow-up.
次要结局
- Mid- to Long-Term Complications(From 30 days to 12 months post-procedure)
- Acute Procedural Success Rate(Intraoperative (immediate post-procedure))
- Incidence of Acute Procedural Complications(Within 24 hours post-procedure)
- Short-term Postoperative Complications(Up to 30 days post-procedure)
- Biomarker Monitoring (e.g., Cardiac Enzymes and Inflammatory Markers)(Baseline and within 72 hours post-procedure)
- Acute Procedural Success Rate(Intraoperative (immediate post-procedure))
- Incidence of Acute Procedural Complications(Within 24 hours post-procedure)
- Short-term Postoperative Complications(Up to 30 days post-procedure)
- Mid- to Long-Term Complications(From 30 days to 12 months post-procedure)
- Biomarker Monitoring (e.g., Cardiac Enzymes and Inflammatory Markers)(Baseline and within 72 hours post-procedure)
- Comparison of parameters related to coronary vasospasm induced by ergonovine provocation testing before and after CNA(Periprocedural)
研究者
Zhibing Lu
The chief of cardiology department
Zhongnan Hospital