Using magnetocardiography to identify heart ischemia in patients with suspected NSTE-ACS

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

This study is testing if a new heart scan using magnetocardiography can quickly and accurately find heart problems in people with chest pain suspected of having a type of heart attack.

Quick facts

• Study type: Observational
• Enrollment: 14090 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06197724 on ClinicalTrials.gov

What this trial studies

This multi-center observational study aims to evaluate the effectiveness of magnetocardiography (MCG) in the rapid and accurate identification of ischemia in patients experiencing chest pain suspected of non-ST-elevation acute coronary syndrome (NSTE-ACS). The study utilizes the spin-exchange relaxation-free (SERF) principle to detect weak magnetic fields generated by the heart, which can provide more diagnostic information than traditional electrical methods. By optimizing and validating MCG models, the study seeks to establish a faster and more reliable strategy for detecting coronary ischemia compared to routine diagnostic techniques. Participants will undergo MCG assessments as part of their evaluation for potential coronary angiography or coronary CTA.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who exhibit symptoms of myocardial ischemia and are suspected of having NSTE-ACS.

Not a fit: Patients with ST-elevation myocardial infarction, severe cardiac conditions, or those unable to undergo MCG due to medical or physical constraints may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to quicker and more accurate diagnoses of myocardial ischemia, improving patient outcomes in emergency settings.

How similar studies have performed: While the use of magnetocardiography is a novel approach, similar studies have shown promise in improving diagnostic accuracy for cardiac conditions.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: Yuguo Chen, Professor — Qliu Hospital of Shandong University
• Study coordinator: Jiaojiao Pang, Doctor

Conditions: Non ST Segment Elevation Acute Coronary Syndrome