MCG is Clinically Applied to Evaluate Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease

NCT ID: NCT06123728

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-19

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Stable Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanhai Hospital, Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanhai Hospital, Guangdong Provincial People's Hospital

Foshan, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenfei He

Role: CONTACT

13380239072

Jishen Guo

Role: CONTACT

18027309031

Facility Contacts

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Wenfei He

Role: primary

13380239072

Jishen Guo

Role: backup

18027309031

Other Identifiers

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GJishen

Identifier Type: -

Identifier Source: org_study_id

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