Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography

Central South University

Status: Not yet enrolling

Conditions: Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia

Treatments: Device: Magnetocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT05718206

202209584

Details and patient eligibility

About

Magnetocardiography (MCG) is a non-invasive and accurate method of detecting myocardial ischemia. However, the previous MCG is limited in clinical practice due to its high working conditions and limited sensitivity. The next-generation MCG based on optical pumped magnetometer (OPM) has the advantages of high sensitivity, high reliability, high usability and low cost, which makes it suitable for most medical scenarios. Thus, this prospective single-center study aimed to use OPM MCG to explore its diagnostic efficacy and predictive value for myocardial ischemia. Participants who will receive coronary angiography examinations will be enrolled in this study. Participants enrolled in the study will also have a 1, 3, 6, 12, 24, 36, and 48-month follow-up for analysis of adverse cardiac events.

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old;
2. Those who are suspected of coronary heart disease and scheduled to undergo coronary angiography;
3. Sign the informed consent.

Exclusion criteria

1. Complex arrhythmia, including frequent premature atrial beats, premature ventricular beats, atrial fibrillation, atrial flutter, and complete bundle branch block;
2. Severe hypertension (> 180/110 mmHg);
3. Congenital heart diseases, valvular heart diseases, or implantation of pacemakers or drug pumps.
4. Severe thoracic or pulmonary diseases, thoracic malformation, or history of thoracic surgery;
5. Pregnant or breastfeeding women;
6. Claustrophobia, or those who can't lie still for 2 minutes in a confined space;
7. Allergy to contrast agent;
8. Renal impairment: serum creatinine > 2,0 mg/dl (176.8 μmol/L) or those who are receiving hemodialysis;
9. Other diseases, including malignant tumors, organ transplantation, and candidates for organ transplantation;
10. History of alcohol or drug abuse (cocaine, heroin, etc.);
11. Participating in clinical studies of other drugs or devices without reaching the time limit for the primary endpoint;
12. Those who aren't suitable for inclusion due to other reason.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Coronary stenosis

Experimental group

Treatment:

Device: Magnetocardiography

Control

Other group

Treatment:

Device: Magnetocardiography