Clinical trial NCT05888246: Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram
Official title: Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram: a Prospective, Observational Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy People
Lead sponsor: Hangzhou Nuochi Life Science Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 \&lt; 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

Primary outcomes:
measure: PR interval
timeFrame: 24 hours
measure: QRS interval
timeFrame: 24 hours
measure: QT interval
timeFrame: 24 hours
measure: Corrected QT interval
timeFrame: 24 hours
measure: The magnetic field intensity parameter (R/T ratio)
timeFrame: 24 hours
measure: Maximum current vector angle (MCV angle)
timeFrame: 24 hours
measure: Maximum current vector amplitude (MCV amplitude)
timeFrame: 24 hours
measure: Total current vector angle (TCV angle)
timeFrame: 24 hours
measure: Total current vector amplitude (TCV amplitude)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianan Wang
role: PRINCIPAL_INVESTIGATOR
References: