NCT06197724

Brief Summary

The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14,090

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

December 11, 2023

Last Update Submit

September 23, 2025

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS

    the sensitivity and specificity of MCG to detect coronary ischemia (defined as stenosis ≥ 90% or fractional flow reserve ≤0.8）

    from the date of enrollment until the date of discharge, up to 30 days

Secondary Outcomes (4)

  • Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.

    from the date of enrollment until the date of discharge, up to 30 days

  • The time saved by using MCG in the detection of NSTEMI compared to troponin

    from the date of enrollment until the date of discharge, up to 30 days

  • Efficacy of MCG in evaluating the severity of coronary lesions.

    from the date of enrollment until the date of discharge, up to 30 days

  • Efficacy of MCG in early stratification of patients with suspected NSTE-ACS

    from the date of enrollment until the date of discharge, up to 30 days

Study Arms (2)

Training and testing cohort

Device: Magnetocardiography

External validation cohort

Device: Magnetocardiography

Interventions

MagnetocardiographyDEVICE

Magnetocardiography

External validation cohortTraining and testing cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chest pain patients with suspected NSTE-ACS

You may qualify if:

  • Age 18 years or older;
  • Patients with symptoms of myocardial ischemia such as angina who are suspected to NSTE-ACS and proposed to undergo CAG or coronary CTA;
  • Signed informed consent.

You may not qualify if:

  • Patients with ST-elevation myocardial infarction (STEMI);
  • Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
  • Patients with Hemodynamic instability (systolic blood pressure\<90 mmHg, or who requires vasoactive drugs), or patients with tachyarrhythmia, Ⅱ degree atrioventricular block and above that have not returned to normal;
  • Patients who have severe renal abnormality with eGFR \<30 ml/min, or patients who are on dialysis;
  • Patients with malignant tumors with predicted survival of less than 1 year;
  • Pregnant or breastfeeding women;
  • Patients who are unable to enter the MCG device, who are unable to perform MCG examination due to interference from metal implants or other reasons, or who are deemed by the investigators to be unsuitable for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Magnetocardiography

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Study Officials

  • Yuguo Chen, Professor

    Qliu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang, Doctor

CONTACT

0086-0531-82165398jiaojiaopang@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 9, 2024

Study Start

January 2, 2024

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations

CN(1)