Evaluating heart function in patients with stable coronary artery disease using magnetocardiography

The Clinical Application of Magnetocardiography (MCG) as a Non-invasive Diagnostic Tool for Evaluating Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease

This study is testing if magnetocardiography can better help doctors understand heart function in people with stable coronary artery disease compared to a standard imaging method.

Quick facts

• Study type: Observational
• Enrollment: 291 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanhai Hospital, Guangdong Provincial People's Hospital (other)
• Locations: 1 site (Foshan, Guangdong)
• Trial ID: NCT06123728 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the diagnostic effectiveness of magnetocardiography (MCG) in patients with stable coronary artery disease (SCAD) and compare it with coronary computed tomography angiography (CCTA). Patients aged 18 and older with a stenosis degree of 30%-90% will undergo both MCG and CCTA examinations. The study will analyze the effectiveness of MCG in evaluating myocardial ischemia using CT-derived fractional flow reserve (CT-FFR) as a reference standard. Additionally, it will evaluate the clinical value of MCG in guiding treatment decisions, including percutaneous coronary intervention (PCI), by tracking major adverse cardiovascular events (MACE) over one year.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stable coronary artery disease and a CCTA stenosis degree between 30% and 90%.

Not a fit: Patients with acute coronary syndrome, severe heart conditions, or those unable to undergo the required examinations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve diagnostic accuracy and treatment strategies for patients with stable coronary artery disease.

How similar studies have performed: While the use of magnetocardiography is a novel approach, similar studies have shown promising results in evaluating cardiac function.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old.
2. Stable coronary artery disease patients with a coronary CTA stenosis degree of 30% to 90%.
3. Sign informed consent.

Exclusion Criteria:

1. Patients diagnosed with acute coronary syndrome.
2. Patients diagnosed with hypertrophic cardiomyopathy.
3. Patients diagnosed with dilated cardiomyopathy.
4. Patients with complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, and complete bundle branch block.
5. Patients with a left ventricular ejection fraction less than 50%.
6. Patients with chronic obstructive pulmonary disease, heart failure, kidney failure, or other serious diseases.
7. Pregnant women.
8. Patients with an allergy to contrast agents.
9. The study subjects who have metal grafts that interfere with magnetic cardiogram examination.
10. The study subjects who are unable to cooperate with magnetocardiogram examination and CTA.
11. Patients who have undergone coronary artery bypass grafting.
12. There are significant artifacts present in coronary CTA.

Where this trial is running

Foshan, Guangdong

• Nanhai Hospital, Guangdong Provincial People's Hospital — Foshan, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Wenfei He

Conditions: Stable Coronary Artery Disease, stable coronary artery disease, magnetocardiography, coronary CTA