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

July 27, 2023 updated by: Hangzhou Nuochi Life Science Co., Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diagnostic test
Diagnostic test: magnetocardiogram.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
24 hours
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).
24 hours
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).
24 hours
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.
24 hours
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.
24 hours
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.
24 hours
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.
24 hours
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.
24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Nuochi Life Science Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianan Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hangzhounuochi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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