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

NCT05888246 | Completed

• 1 other identifier: Hangzhounuochi
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy People

Outcome Measures

Primary Outcomes (9)

• PR interval

  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).

  24 hours

• QRS interval

  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).

  24 hours

• QT interval

  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).

  24 hours

• Corrected QT interval

  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.

  24 hours

• The magnetic field intensity parameter (R/T ratio)

  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.

  24 hours

• Maximum current vector angle (MCV angle)

  The Angle of the maximum current vector was measured at the vertex of QRS and T wave respectively.

  24 hours

• Maximum current vector amplitude (MCV amplitude)

  The amplitude of the maximum current vector was measured at the vertex of QRS wave and T wave respectively.

  24 hours

• Total current vector angle (TCV angle)

  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.

  24 hours

• Total current vector amplitude (TCV amplitude)

  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.

  24 hours

Study Arms (1)

Diagnostic test

EXPERIMENTAL

Diagnostic test: magnetocardiogram.

Diagnostic Test: Magnetocardiogram

Interventions

Magnetocardiogram 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.

Diagnostic test

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy people aged 18-70 years old;
• 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;
• No history of coronary heart disease;
• ECG did not indicate myocardial ischemia or infarction;
• Sinus rhythm without arrhythmia;
• 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.

You may not qualify if:

• Acute coronary syndrome requires emergency PCI treatment, and it is estimated that magnetic cardiogram examination will affect the timing of emergency PCI surgery;
• 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;
• 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;
• Severe tachycardia (ventricular rate \> 150 beats/min), ventricular flutter, ventricular fibrillation and other malignant arrhythmias;
• Subjects unable to lie flat (supine position);
• Subjects with mental illness, unconscious or uncontrollable ability; Or claustrophobic subjects;
• Other circumstances in which the investigator considers the subject inappropriate for participation in the study

Sponsors & Collaborators

• Hangzhou Nuochi Life Science Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Study Officials

• Jianan Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: June 5, 2023
• Study Start: May 7, 2022
• Primary Completion: May 14, 2022
• Study Completion: May 14, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)