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

Not Applicable

Completed

• Conditions: Healthy People
• Interventions: Diagnostic Test: Magnetocardiogram

• Registration Number: NCT05888246
• Lead Sponsor: Hangzhou Nuochi Life Science Co., Ltd.

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.

Study Timeline

• Study Start: 2022-05-07
• Primary Completion: 2022-05-14
• Study Completion: 2022-05-14
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic test	Magnetocardiogram	Diagnostic test: magnetocardiogram.

Primary Outcome Measures

Name	Time	Method
Maximum current vector angle (MCV angle)	24 hours	The Angle of the maximum current vector was measured at the vertex of QRS and T wave respectively.
PR interval	24 hours	PR interval is defined as the position from the starting point of P wave to the starting point of QRS wave after the superposition of 36 channels in the magnetocardiogram (butterfly diagram).
QT interval	24 hours	QT interval is defined as the time (ms) from the beginning of Q wave to the end of T wave after the stacking of 36 channels in the magnetocardiogram (butterfly diagram).
The magnetic field intensity parameter (R/T ratio)	24 hours	The magnetic field intensity parameter (R/T ratio) is defined as the ratio of the maximum magnetic field intensity of the r-wave vertex to the T-wave vertex of the magnetocardiogram calculated based on the isomagnetic map.
QRS interval	24 hours	QRS interval is defined as the time (ms) from the beginning of QRS to the end of QRS after the stacking of 36 channels in the magnetocardiogram (butterfly diagram).
Corrected QT interval	24 hours	The corrected QT interval was defined as the QTC interval (ms) after the stacking of 36 channels in the magnetocardiogram (butterfly diagram). QTc = QT/(RR\^0.5), RR is the average RR interval calculated by cardiac magnetic waveform, QT is QT interval.
Maximum current vector amplitude (MCV amplitude)	24 hours	The amplitude of the maximum current vector was measured at the vertex of QRS wave and T wave respectively.
Total current vector angle (TCV angle)	24 hours	TCV represents the total current vector, which is the sum of all current vectors of 36 channels in the magnetocardiogram. First calculate the vector sum of the 36 channels, and finally calculate the angles.
Total current vector amplitude (TCV amplitude)	24 hours	TCV represents the total current vector, which is the sum of all current vectors of 36 channels in the magnetocardiogram. First calculate the vector sum of the 36 channels, and finally calculate the amplitude.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China