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

Recruiting

• Conditions: Non ST Segment Elevation Acute Coronary Syndrome
• Interventions: Device: Magnetocardiography

• Registration Number: NCT06197724
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-26
• Study Start: 2024-01-02
• Study First Posted: 2024-01-09
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2224

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
External validation cohort	Magnetocardiography	-
Training and testing cohort	Magnetocardiography	-

Primary Outcome Measures

Name	Time	Method
Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS	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 Outcome Measures

Name	Time	Method
The time saved by using MCG in the detection of NSTEMI compared to troponin	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).
Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.	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.
Efficacy of MCG in evaluating the severity of coronary lesions.	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.
Efficacy of MCG in early stratification of patients with suspected NSTE-ACS	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.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China