Determination of MCG Reference Intervals in Healthy Individuals

NCT06198777 | Unknown DMC

• 1 other identifier: MCG-healthy
• Study Type: observational
• Target: 2,396
• Locations: 1 country
• Sites: 1

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.

Conditions

MCG Reference Intervals Determination for Healthy Adults; Health, Subjective

Keywords

Healthy Adults; Reference Intervals

Outcome Measures

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.

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

Secondary Outcomes (4)

• Reference value for MCV (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

  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

  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

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

Study Arms (1)

Healthy adults

Device: Magnetometer

Interventions

Magnetometer DEVICE

Inspection equipment for magnetocardiography

Healthy adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults aged 18 years and older

You may qualify if:

• Age 18 years or older.
• Those with no hospitalization for any reason in the 6 months prior to the study.
• Those who are not currently taking any prescribed medications.
• 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.
• Those with no risk factors for cardiovascular diseases, including hypertension, diabetes mellitus, hyperlipidemia.
• Those with no history of smoking (previous non-smoking or smoking cessation \>6 months).
• Those with no excessive alcohol consumption (average daily alcohol consumption \<3 drinks, 1 drink = beer 355mL / white wine 44mL / red wine 118mL).
• Signed informed consent.

You may not qualify if:

• Those with body mass index \>28kg/m2 or \<18kg/m2.
• Those with resting heart rate \<50 beats/min, or \>110 beats/min.
• Those with resting systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90 mmHg.
• Those with fasting blood glucose ≥7 mmol/L, and/or random blood glucose ≥11.1 mmol/L.
• Those with total cholesterol ≥6.2 mmol/L or low-density lipoprotein cholesterol ≥4.1 mmol/L.
• Those with abnormal electrocardiograms, such as arrhythmias, ST-T changes, and pathologic electrical axis deflections.
• 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.
• Those with respiratory diseases, kidney diseases, liver diseases, endocrine diseases, anaemia or other blood diseases, connective tissue diseases, malignant tumors and other diseases.
• Professional athletes, pregnant or lactating women, psychological or psychiatric disorders such as depression.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Study Officials

• Yuguo Chen, Professor

  Qliu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang, Doctor

CONTACT

0086-0531-82165674; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: January 8, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2023-12

Locations

CN (1)