MCG for Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients

Magnetocardiography as an Innovative Diagnostic Tool for Early and Accurate Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Non ST Segment Elevation Acute Coronary Syndrome
• Intervention / Treatment: Device: Magnetocardiography

Detailed Description

Rapid and accurate Identification of ischemia in patients with chest pain suspected of non-ST-elevation-acute coronary syndrome (NSTE-ACS) is of great clinical significance for timely and effective treatment. Magnetocardiography based on spin-exchange relaxation-free (SERF) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. Magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (MCG) contains more information of diagnostic value of ischemia. The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.

• Study Type: Observational
• Enrollment (Estimated): 14090

Contacts and Locations

• Study Contact: Name: Jiaojiao Pang, Doctor; Phone Number: 0086-0531-82165398; Email: jiaojiaopang@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Jiaojiao Pang, Doctor; Phone Number: 0086-0531-82165398; Email: jiaojiaopang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

chest pain patients with suspected NSTE-ACS

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with ST-elevation myocardial infarction (STEMI);
2. Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
3. 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;
4. Patients who have severe renal abnormality with eGFR <30 ml/min, or patients who are on dialysis;
5. Patients with malignant tumors with predicted survival of less than 1 year;
6. Pregnant or breastfeeding women;
7. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training and testing cohort	Device: Magnetocardiography; Magnetocardiography
External validation cohort	Device: Magnetocardiography; Magnetocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.	A normal ECG is determined by two cardiologists with over five years of working experience. If there is any objection, the decision shall be made by a third cardiologist of the same qualifications or above. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.	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	The time for the detection of NSTEMI is from the timepoint of first medical contact to the timepoint of MCG report showing ischemia or the first report of troponin that over the 99th percentile of the Upper reference limit (URL).	from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in evaluating the severity of coronary lesions.	The severity of coronary lesions is determined by using CAG/CTA and fractional flow reserve. Severe degree is defined as ≥90% stenosis of at least one main vessel or branch vessel with diameter ≥2mm. Moderate degree is defined as 50%-89% stenosis and fractional flow reserve ≤0.8. Mild degree is defined as <50% stenosis and fractional flow reserve ≤0.8, or stenosis 50%-89% and fractional flow reserve> 0.8. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.	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	For early stratification measurement, patients with suspected NSTE-ACS are assessed by 30d (from enrollment) MACE and classified as high or low risk. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy of MCG.	from the date of enrollment until the date of discharge, up to 30 days

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; First People's Hospital of Hangzhou; Guangdong Provincial Hospital of Traditional Chinese Medicine; Second Affiliated Hospital, School of Medicine, Zhejiang University; First Affiliated Hospital Xi'an Jiaotong University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Qianfoshan Hospital; Linyi People's Hospital; Weifang People's Hospital; Chongqing Emergency Medical Center; Weihai Central Hospital; Heze Municipal Hospital; Jining First People's Hospital
• Investigators: Principal Investigator: Yuguo Chen, Professor, Qliu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Acute Coronary Syndrome; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Magnetometry; Magnetocardiography
• Other Study ID Numbers: MCG-NSTEACS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No