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Determination of MCG Reference Intervals in Healthy Individuals

Establishing Reference Intervals for Magnetocardiography Parameters in Healthy Adults in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06198777
Enrollment
2396
Registered
2024-01-10
Start date
2024-01-08
Completion date
2024-12-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Subjective, MCG Reference Intervals Determination for Healthy Adults

Keywords

Healthy Adults, Reference Intervals

Brief summary

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.

Interventions

Inspection equipment for magnetocardiography

Sponsors

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

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Reference value for NPM (physio-MCG parameter,%)from the date of enrollment until the date of the completion of all assessments, up to 30 daysMCG device is used for the measurement of the physio-MCG parameter, and we will calculate the reference value.

Secondary

MeasureTime frameDescription
Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of R wave peakfrom the date of enrollment until the date of the completion of all assessments, up to 30 daysMCG device is used for the measurement of maximum current vector amplitude (pT/m) at the timepoint of R wave peak.
Reference value for TCV (total current vector) angle at the timepoint of R wave peakfrom the date of enrollment until the date of the completion of all assessments, up to 30 daysMCG device is used for the measurement of total current vector angle at the timepoint of R wave peak.
Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of T wave peakfrom the date of enrollment until the date of the completion of all assessments, up to 30 daysMCG device is used for the measurement of maximum current vector amplitude (pT/m) at the timepoint of T wave peak.
Reference value for TCV (total current vector) angle at the timepoint of T wave peakfrom the date of enrollment until the date of the completion of all assessments, up to 30 daysMCG device is used for the measurement of total current vector angle at the timepoint of T wave peak.

Countries

China

Contacts

Primary ContactJiaojiao Pang, Doctor
jiaojiaopang@126.com0086-0531-82165674

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026