Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram

Hangzhou Nuochi Life Science

Status: Completed

Conditions: Healthy People

Treatments: Diagnostic Test: Magnetocardiogram

Study type: Interventional

Funder types: Industry

Identifiers

NCT05888246

Hangzhounuochi

Details and patient eligibility

About

A prospective and observational clinical study of measuring the range of cardiac magnetic parameters in healthy people with the magnetocardiogram manufactured by Hangzhou Nuochi Life Science Co., LTD

Full description

This study is a prospective and observational study on the collection of cardiac magnetic signals from healthy subjects by magnetocardiogram. It is expected that 412 subjects will be examined by magnetocardiography, and the range of parameters related to magnetocardiography in healthy subjects will be reported.

Enrollment: 412 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy people aged 18-70 years old;
2. Subjects receiving physical examination in physical examination institutions, or in other departments other than heart disease (such as orthopedics, gynecology, etc.), or in cardiology department, excluded from coronary heart disease;
3. No history of coronary heart disease;
4. ECG did not indicate myocardial ischemia or infarction;
5. Sinus rhythm without arrhythmia;
6. The subject or the subject's legal representative has been informed of the nature of the study, understands the purpose of the clinical study, voluntarily participates in the study and signs the informed consent.

Exclusion criteria

1. Acute coronary syndrome requires emergency PCI treatment, and it is estimated that magnetic cardiogram examination will affect the timing of emergency PCI surgery;
2. Subjects with metal implants in the thoracic cavity (including the heart cavity), such as those who have received pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implantable cardioverter defibrillator (ICD) implantation, or those who have received metal heart valve implantation;
3. There is hemodynamic instability, which is defined as systolic blood pressure < 80mmHg, or cardiogenic shock; Or need vasoactive drug therapy; Intra-aortic balloon counterpulsation may be required; Or other hemodynamic support devices; As syndrome;
4. Severe tachycardia (ventricular rate > 150 beats/min), ventricular flutter, ventricular fibrillation and other malignant arrhythmias;
5. Subjects unable to lie flat (supine position);
6. Subjects with mental illness, unconscious or uncontrollable ability; Or claustrophobic subjects;
7. Other circumstances in which the investigator considers the subject inappropriate for participation in the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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412 participants in 1 patient group

Diagnostic test

Experimental group

Description:

Diagnostic test: magnetocardiogram.

Treatment:

Diagnostic Test: Magnetocardiogram