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

S

Shandong University

Status

Not yet enrolling

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Treatments

Device: Magnetocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT06197724
MCG-NSTEACS

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,224 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

2,224 participants in 2 patient groups

Training and testing cohort
Treatment:
Device: Magnetocardiography
External validation cohort
Treatment:
Device: Magnetocardiography

Trial contacts and locations

1

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Central trial contact

Jiaojiao Pang, Doctor

Data sourced from clinicaltrials.gov

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