Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography

NCT ID: NCT05718206

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2025-08-14

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Coronary stenosis

Group Type: EXPERIMENTAL

Magnetocardiography

Intervention Type: DEVICE

Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.

Control

Group Type: OTHER

Magnetocardiography

Intervention Type: DEVICE

Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.

Interventions

Magnetocardiography

Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jie Liu

Role: CONTACT

208111002@csu.edu.cn

86-18932462423

Other Identifiers

202209584

Identifier Type: -

Identifier Source: org_study_id