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Recruiting NCT06197724

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

— Observational Non ST Segment Elevation Acute Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetocardiography.
Who it may be relevant to
Registry conditions: Non ST Segment Elevation Acute Coronary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Device Magnetocardiography
    Magnetocardiography

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT06197724 · MCG-NSTEACS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗