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RecruitingNCT06198777Updated Aug 21, 2024

Determination of MCG Reference Intervals in Healthy Individuals

An observational study in MCG Reference Intervals Determination for Healthy Adults and Health, Subjective, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Qilu Hospital of Shandong University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
2,396
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • MCG Reference Intervals Determination for Healthy Adults
  • Health, Subjective

Keywords

  • Healthy Adults
  • Reference Intervals
03

In context

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adults aged 18 years and older

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
2,396 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy adults

    Device: Magnetometer

Interventions

  • DeviceMagnetometer

    Inspection equipment for magnetocardiography

06

What researchers measure

Primary outcomes

  1. Reference value for NPM (physio-MCG parameter,%)

    MCG device is used for the measurement of the physio-MCG parameter, and we will calculate the reference value.

    Time frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days

Secondary outcomes

  1. Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of R wave peak

    MCG device is used for the measurement of 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

  2. Reference value for TCV (total current vector) angle at the timepoint of R wave peak

    MCG device is used for the measurement of 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

  3. Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of T wave peak

    MCG device is used for the measurement of 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

  4. Reference value for TCV (total current vector) angle at the timepoint of T wave peak

    MCG device is used for the measurement of 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

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06198777
Lead sponsor
Qilu Hospital of Shandong University
Collaborators
Linyi People's Hospital, Weifang People's Hospital, Jining First People's Hospital, Weihai Central Hospital, The First Affiliated Hospital with Nanjing Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Second Affiliated Hospital, School of Medicine, Zhejiang University, First Affiliated Hospital Xi'an Jiaotong University, Guangdong Provincial Hospital of Traditional Chinese Medicine, First People's Hospital of Hangzhou, Chongqing Emergency Medical Center, Heze Municipal Hospital, Qianfoshan Hospital
Responsible party
Sponsor
First posted
Jan 10, 2024
Start date
Jan 8, 2024
Primary completion
Oct 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 21, 2024

Study contacts

Jiaojiao Pang, Doctor
Contact
jiaojiaopang@126.com
0086-0531-82165674
Yuguo Chen, Professor
principal investigator · Qliu Hospital of Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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