Clinical trial NCT06198777: Determination of MCG Reference Intervals in Healthy Individuals
Official title: Establishing Reference Intervals for Magnetocardiography Parameters in Healthy Adults in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MCG Reference Intervals Determination for Healthy Adults
Health, Subjective
Keywords: Healthy Adults
Reference Intervals
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Linyi People's Hospital
name: Weifang People's Hospital
name: Jining First People's Hospital
name: Weihai Central Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: First People's Hospital of Hangzhou
name: Chongqing Emergency Medical Center
name: Heze Municipal Hospital
name: Qianfoshan Hospital
First posted: 2024-01-10
Enrollment: 2396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults aged 18 years and older

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reference value for NPM (physio-MCG parameter,%)
timeFrame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
Secondary outcomes:
measure: Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of R wave peak
timeFrame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
measure: Reference value for TCV (total current vector) angle at the timepoint of R wave peak
timeFrame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
measure: Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of T wave peak
timeFrame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
measure: Reference value for TCV (total current vector) angle at the timepoint of T wave peak
timeFrame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qliu Hospital of Shandong University
name: Yuguo Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: