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

NCT ID: NCT05888246

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-07
• Study Completion Date: 2022-05-14

Brief Summary

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

Detailed 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.

Conditions

Healthy People

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic test

Diagnostic test: magnetocardiogram.

Group Type: EXPERIMENTAL

Magnetocardiogram

Intervention Type: DIAGNOSTIC_TEST

Magnetocardiogram consists of acquisition and control system (including software) and detection part. Acquisition and control system mainly includes: cabinet, display, host, sensor. The detection part mainly includes: inspection bed, array sensor support frame, magnetic shielding equipment.

Interventions

Magnetocardiogram

Magnetocardiogram consists of acquisition and control system (including software) and detection part. Acquisition and control system mainly includes: cabinet, display, host, sensor. The detection part mainly includes: inspection bed, array sensor support frame, magnetic shielding equipment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Nuochi Life Science Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianan Wang

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

Hangzhounuochi

Identifier Type: -

Identifier Source: org_study_id