Healthy PeopleNCT05888246

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

A study testing Magnetocardiogram in people with Healthy People, run by Hangzhou Nuochi Life Science Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy People
What is being tested?: Magnetocardiogram
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 412 participants
Where: 1 siteChina
Study dates: 7 May 2022to 14 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram: a Prospective, Observational Clinical Study

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

Read the 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
Being tested: Magnetocardiogram

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MagnetocardiogramDiagnostic 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.

Study groups in NCT05888246
Study group	Role	What they receive
Diagnostic test	Experimental	Diagnostic test: magnetocardiogram. Receives: Diagnostic Test: Magnetocardiogram

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 202214 May 2022

First posted5 Jun 2023
Study start7 May 2022
Primary completion14 May 2022
Study completion14 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy PeopleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 412 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05888246
Sponsor's protocol ID: Hangzhounuochi
Status last verified: Jul 2023
First submitted: 29 Jun 2022
Last updated: 28 Jul 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy People trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measuring the Range of Cardiac Magnetic Parameters in Healthy Subjects by Magnetocardiogram: a Prospective, Observational Clinical Study
ClinicalTrials.gov ID: NCT05888246
Acronym / sponsor ID: Hangzhounuochi
Conditions: Healthy People
Study type: Interventional
Recruitment status: Completed
Enrolment: 412 participants (actual)
Lead sponsor: Hangzhou Nuochi Life Science Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 May 2022 (actual)
Primary completion: 14 May 2022 (actual)
Study completion: 14 May 2022 (actual)
First posted: 5 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic test	Experimental	Diagnostic Test: MagnetocardiogramDiagnostic test: magnetocardiogram.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MagnetocardiogramMagnetocardiogram 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	Diagnostic test

Primary outcome

PR interval
Time frame: 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).
QRS interval
Time frame: 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).
QT interval
Time frame: 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).
Corrected QT interval
Time frame: 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.
The magnetic field intensity parameter (R/T ratio)
Time frame: 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.
Maximum current vector angle (MCV angle)
Time frame: 24 hours
The Angle of the maximum current vector was measured at the vertex of QRS and T wave respectively.
Maximum current vector amplitude (MCV amplitude)
Time frame: 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)
Time frame: 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)
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jianan Wang principal investigator

Second Affiliated Hospital, Zhejiang University, School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Magnetocardiogram in people with Healthy People, run by Hangzhou Nuochi Life Science Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PR interval (time frame: 24 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05888246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.