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

NCT07341932 | Recruiting DMC

• 1 other identifier: 2024AZB1003
• Study Type: interventional
• Target: 1,312
• Locations: 1 country
• Sites: 5

Brief 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. 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. 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.

Conditions

Stable Coronary Artery Disease CAD

Keywords

Stable coronary artery disease CAD; MCG; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA)

  Compare the proportion of patients with non-obstructive coronary artery disease on planned invasive coronary angiography (ICA) performed within 90 days between the MCG-guided group and the conventional management group, where non-obstructive disease is defined as coronary stenosis \<70% or an invasive fractional flow reserve (FFR) value ≥0.8.

  From randomization through day 90 after enrollment.

Secondary Outcomes (3)

• Seattle Angina Questionnaire (SAQ) Score

  From randomization through month 12 after enrollment.

• MACE

  From randomization through month 12 after enrollment.

• Healthcare Expenditure

  From randomization through month 12 after enrollment.

Study Arms (2)

Conventional Management Group

EXPERIMENTAL

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.

Diagnostic Test: Conventional Management Group

MCG Group

EXPERIMENTAL

Based on MCG results, either ICA or optimal medical therapy was recommended.

Diagnostic Test: MCG Group

Interventions

MCG Group DIAGNOSTIC_TEST

Based on MCG results, either ICA or optimal medical therapy was recommended.

MCG Group

Conventional Management Group DIAGNOSTIC_TEST

Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.

Conventional Management Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (5)

Air Force Medical Center, People's Liberation Army of China

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Beijing United Family Hospital

Beijing, Beijing Municipality, China

RECRUITING

首都医科大学附属北京安贞医院

Beijing, Beijing Municipality, China

RECRUITING

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

NOT YET RECRUITING

Urumqi Friendship Hospital

Ürümqi, Xinjiang Uygur Autonomous Region, China

NOT YET RECRUITING

Central Study Contacts

xiantao Song

CONTACT

86-010-64412431; tcc2033@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation concealment was implemented using a web-based central randomization system. Study site staff entered each participant's basic information (initials, age, gender, subject ID, etc.) and stratification factors into the system. Based on the predefined principles, the system automatically generated a unique random number and subject ID, and notified the investigator at the respective site via the network regarding the participant's assignment to either the intervention or control group. Upon receiving the randomization result, the site investigator administered the corresponding treatment-either the intervention or control therapy-according to the assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology Ward A, Department of Cardiology I

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The raw data will be made publicly available starting 1 year after study completion and will remain accessible for a period of 5 years.
• Access Criteria: Physicians in the relevant field may access the Individual Participant Data (IPD) and supporting information. The study protocol, informed consent forms, and raw data are available upon request via email.

Locations

CN (5)