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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Air Force Medical Center, People's Liberation Army of China
NOT_YET_RECRUITING
Beijing
Beijing United Family Hospital
RECRUITING
Beijing
首都医科大学附属北京安贞医院
RECRUITING
Beijing
The Third People's Hospital of Chengdu
NOT_YET_RECRUITING
Chengdu
Urumqi Friendship Hospital
NOT_YET_RECRUITING
Ürümqi
Contact Information
Primary
xiantao Song
tcc2033@163.com
86-010-64412431
Time Frame
Start Date: 2026-03-17
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 1312
Treatments
Experimental: Conventional Management Group
Treatment strategies were recommended based on stenosis severity, pre-test probability, and functional test results: For patients with 50-70% stenosis, if the pre-test probability was \<15%, treatment recommendations had to be made by clinicians integrating one or more functional test results (e.g., exercise ECG, stress echocardiography, SPECT, stress CMR); if the pre-test probability was ≥15%, it was advised to recommend treatment strategies considering functional test results. For patients with CCTA-indicated 70-90% stenosis, clinicians could directly recommend ICA or optimal medical therapy.
Experimental: MCG Group
Based on MCG results, either ICA or optimal medical therapy was recommended.
Related Therapeutic Areas
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov