Clinical trial NCT06123728: MCG is Clinically Applied to Evaluate Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease
Official title: The Clinical Application of Magnetocardiography (MCG) as a Non-invasive Diagnostic Tool for Evaluating Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stable Coronary Artery Disease
Keywords: stable coronary artery disease
magnetocardiography
coronary CTA
Lead sponsor: Nanhai Hospital, Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected stable coronary artery disease were enrolled in a consecutive group at Nanhai Hospital of Guangdong Provincial People's Hospital.

Brief summary: The objective of this observational study is to evaluate the diagnostic effectiveness of magnetocardiography (MCG) in patients with stable coronary artery disease (SCAD) and compare it with coronary CTA (CCTA). Additionally, the study aims to determine the most suitable diagnostic index for MCG. The primary question it seeks to address is whether MCG or MCG combined with CCTA can be utilized to guide the clinical application of percutaneous coronary intervention (PCI) for coronary heart disease.

Detailed description: 1. Patients aged≥18 years with stable coronary artery disease (CCTA stenosis 30%-90%) underwent sequential examinations of MCG and CCTA. The results of CCTA were assessed using CT-FFR, and the diagnostic effectiveness of MCG in evaluating myocardial ischemia was analyzed using CT-FFR as the reference standard. Simultaneously, MCG was compared to CCTA to determine the clinical value of MCG in the functional evaluation of myocardial ischemia.
2. Coronary angiography was performed in patients who met the criteria for the procedure, and revascularization was carried out based on the intraoperative situation. Patients who underwent revascularization were followed up for 1 year, with major adverse cardiovascular events (MACE) as the endpoint. The clinical value of MCG in guiding the treatment of patients with SCAD was evaluated by reviewing the proportion of coronary angiography, revascularization, and MACE in the enrolled patients.

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.

Primary outcomes:
measure: Consistency in comparing MCG and CT-FFR
timeFrame: 1 year
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Foshan
country: China
facility: Nanhai Hospital, Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: