Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial

Обзор

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: 1. 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. 2. 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.

Вмешательства

• Диагностический тест MCG Group
  Based on MCG results, either ICA or optimal medical therapy was recommended.
• Диагностический тест Conventional Management Group
  Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.

Первичные конечные точки

• Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA) [Срок оценки: From randomization through day 90 after enrollment.]

Вторичные конечные точки (3)

• Seattle Angina Questionnaire (SAQ) Score [Срок оценки: From randomization through month 12 after enrollment.]
• MACE [Срок оценки: From randomization through month 12 after enrollment.]
• Healthcare Expenditure [Срок оценки: From randomization through month 12 after enrollment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Air Force Medical Center, People's Liberation Army of China — Пекин
• Beijing United Family Hospital — Пекин
• 首都医科大学附属北京安贞医院 — Пекин
• The Third People's Hospital of Chengdu — Чэнду
• Urumqi Friendship Hospital — Ürümqi

Идентификаторы

NCT: NCT07341932 · 2024AZB1003 · 2024AZB1003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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