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NCT Number: NCT06197724

MCG for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Jiaojiao Pang, Doctor

CONTACT

[email protected]

0086-0531-82165398

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Magnetocardiography

Device

Magnetocardiography

Primary outcomes

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

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

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

Secondary outcomes

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

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

    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.

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

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

    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).

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

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

    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.

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaojiao Pang, Doctor

CONTACT

[email protected]

0086-0531-82165398

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Chongqing Emergency Medical Center
  • First Affiliated Hospital Xi'an Jiaotong University
  • First People's Hospital of Hangzhou
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Heze Municipal Hospital
  • Jining First People's Hospital
  • Linyi People's Hospital
  • Qianfoshan Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital with Nanjing Medical University
  • Weifang People's Hospital
  • Weihai Central Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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