Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,312
- 试验地点
- 5
- 主要终点
- Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA)
研究概览
简要总结
This rigorously designed randomized controlled trial aims to investigate whether Magnetocardiography (MCG) can optimize the clinical pathway, improve quality of life, and reduce healthcare costs in patients with stable coronary artery disease (SCAD) within real-world clinical settings, thereby generating evidence for the future application of MCG in clinical decision-making pathways.
Stable CAD patients with at least one major coronary vessel showing 50%-90% stenosis on coronary CTA will be enrolled based on predefined criteria. Stratified by study center and using a central web-based randomization system, participants will be allocated in a 1:1 ratio to either the **MCG-guided group** (where treatment recommendations for invasive coronary angiography [ICA] or optimal medical therapy are based on MCG results) or the **conventional management group** (where treatment strategy is based on stenosis severity, pre-test probability, and functional test results).
The study will proceed with the following evaluations:
- Compare the proportion of patients with non-obstructive coronary artery disease on planned ICA performed within 90 days between the two groups, testing the hypothesis that this proportion is lower in the MCG-guided group.
- Conduct telephone follow-ups at 90 days, 6 months, and 12 months post-enrollment to compare between-group differences in the rate of Major Adverse Cardiovascular Events (MACE), Seattle Angina Questionnaire (SAQ) scores, and total healthcare expenditures during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Allocation concealment was implemented using a web-based central randomization system. Study site staff entered each participant's basic information (initials, age, gender, subject ID, etc.) and stratification factors into the system. Based on the predefined principles, the system automatically generated a unique random number and subject ID, and notified the investigator at the respective site via the network regarding the participant's assignment to either the intervention or control group. Upon receiving the randomization result, the site investigator administered the corresponding treatment-either the intervention or control therapy-according to the assigned group.
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 18-80 years, regardless of gender.
- •Patients with stable coronary artery disease (CAD).
- •Coronary computed tomography angiography (CCTA) shows at least one major coronary vessel (diameter ≥2.5 mm) with 50-90% stenosis. Patients with 50-69% stenosis must have typical or atypical angina; for those with 70-90% stenosis, the presence of chest pain symptoms is not required.
- •*Note: Chest pain is characterized by the following three features:* *(1) Chest discomfort lasting less than 15 minutes;* *(2) Precipitated by physical exertion or emotional stress;* *(3) Relieved by rest or nitrates.* *Based on these, angina is classified as:*
- •*Typical angina: all 3 features are present;*
- •*Atypical angina: 2 features are present;*
- •*Non-anginal chest pain: 1 or no feature is present.*
- •Willing to participate in the study and provide written informed consent.
排除标准
- •Previous myocardial infarction, PCI, CABG, or coronary angiography indicating stenosis ≥50% in a major vessel.
- •CCTA indicating left main coronary artery stenosis >50% and/or three-vessel disease.
- •History of cardiac dysfunction (≥ NYHA Class III), severe congenital heart disease, valvular heart disease, or cardiomyopathy.
- •Complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, atrial fibrillation, atrial flutter, etc.
- •History of metal implant placement (including mechanical valves, pacemakers, orthopedic internal fixation plates, drug pumps, etc.).
- •Claustrophobia.
- •Severe thoracic deformity.
- •Active bleeding.
- •Any disease with an expected survival of less than 1 year.
- •Completion of any of the following tests prior to enrollment: exercise ECG, stress echocardiography, stress SPECT, or stress CMR.
- •Any other condition where the investigator considers the patient unsuitable for this study.
结局指标
主要结局
Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA)
时间窗: From randomization through day 90 after enrollment.
Compare the proportion of patients with non-obstructive coronary artery disease on planned invasive coronary angiography (ICA) performed within 90 days between the MCG-guided group and the conventional management group, where non-obstructive disease is defined as coronary stenosis \<70% or an invasive fractional flow reserve (FFR) value ≥0.8.
次要结局
- Seattle Angina Questionnaire (SAQ) Score(From randomization through month 12 after enrollment.)
- MACE(From randomization through month 12 after enrollment.)
- Healthcare Expenditure(From randomization through month 12 after enrollment.)
研究者
song xiantao
Director of Cardiology Ward A, Department of Cardiology I
Beijing Anzhen Hospital