Determination of MCG Reference Intervals in Healthy Individuals

August 19, 2024 updated by: Qilu Hospital of Shandong University

Establishing Reference Intervals for Magnetocardiography Parameters in Healthy Adults in China

Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting cardiac abnormalities. However, the results of MCG cannot be evaluated without defined reference intervals. This is a multicenter cross-sectional study designed to establish reference values for MCG parameters healthy adults in China.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2396

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy adults aged 18 years and older

Description

Inclusion Criteria:

  1. Age 18 years or older.
  2. Those with no hospitalization for any reason in the 6 months prior to the study.
  3. Those who are not currently taking any prescribed medications.
  4. Those with no history of cardiovascular diseases, including coronary artery disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic coarctation, or peripheral arterial disease.
  5. Those with no risk factors for cardiovascular diseases, including hypertension, diabetes mellitus, hyperlipidemia.
  6. Those with no history of smoking (previous non-smoking or smoking cessation >6 months).
  7. Those with no excessive alcohol consumption (average daily alcohol consumption <3 drinks, 1 drink = beer 355mL / white wine 44mL / red wine 118mL).
  8. Signed informed consent.

Exclusion Criteria:

  1. Those with body mass index >28kg/m2 or <18kg/m2.
  2. Those with resting heart rate <50 beats/min, or >110 beats/min.
  3. Those with resting systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90 mmHg.
  4. Those with fasting blood glucose ≥7 mmol/L, and/or random blood glucose ≥11.1 mmol/L.
  5. Those with total cholesterol ≥6.2 mmol/L or low-density lipoprotein cholesterol ≥4.1 mmol/L.
  6. Those with abnormal electrocardiograms, such as arrhythmias, ST-T changes, and pathologic electrical axis deflections.
  7. Those with cardiac ultrasonographic pathologic findings, such as left ventricular hypertrophy, left ventricular dilatation, abnormal ventricular wall motion, and valvular regurgitation or stenosis of more than mild degree.
  8. Those with respiratory diseases, kidney diseases, liver diseases, endocrine diseases, anaemia or other blood diseases, connective tissue diseases, malignant tumors and other diseases.
  9. Professional athletes, pregnant or lactating women, psychological or psychiatric disorders such as depression.
  10. Those who are unable to perform magnetocardiography due to claustrophobia, etc., or those who are unable to cooperate with the corresponding examinations required by the study for various reasons.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy adults
Device: Magnetometer
Inspection equipment for magnetocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reference value for NPM (physio-MCG parameter,%)
Time Frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
MCG device is used for the measurement of the physio-MCG parameter, and we will calculate the reference value.
from the date of enrollment until the date of the completion of all assessments, up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of R wave peak
Time Frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
MCG device is used for the measurement of maximum current vector amplitude (pT/m) at the timepoint of R wave peak.
from the date of enrollment until the date of the completion of all assessments, up to 30 days
Reference value for TCV (total current vector) angle at the timepoint of R wave peak
Time Frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
MCG device is used for the measurement of total current vector angle at the timepoint of R wave peak.
from the date of enrollment until the date of the completion of all assessments, up to 30 days
Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of T wave peak
Time Frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
MCG device is used for the measurement of maximum current vector amplitude (pT/m) at the timepoint of T wave peak.
from the date of enrollment until the date of the completion of all assessments, up to 30 days
Reference value for TCV (total current vector) angle at the timepoint of T wave peak
Time Frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
MCG device is used for the measurement of total current vector angle at the timepoint of T wave peak.
from the date of enrollment until the date of the completion of all assessments, up to 30 days

Collaborators and Investigators

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

Sponsor

Qilu Hospital of Shandong University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
First People's Hospital of Hangzhou
Guangdong Provincial Hospital of Traditional Chinese Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital Xi'an Jiaotong University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Linyi People's Hospital
Weifang People's Hospital
Chongqing Emergency Medical Center
Weihai Central Hospital
Central hospital Affiliated to Shandong First Medical University
Heze Municipal Hospital
Jining First People's Hospital

Investigators

  • Principal Investigator: Yuguo Chen, Professor, Qliu Hospital of Shandong 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)

January 8, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCG-healthy

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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