Establishing reference values for magnetocardiography in healthy adults

Establishing Reference Intervals for Magnetocardiography Parameters in Healthy Adults in China

This study is trying to find normal heart measurement values using magnetocardiography in healthy adults to help better understand heart health.

Quick facts

• Study type: Observational
• Enrollment: 2396 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06198777 on ClinicalTrials.gov

What this trial studies

This observational study aims to determine reference intervals for magnetocardiography (MCG) parameters in healthy adults across multiple centers in China. By utilizing a magnetometer, the study will collect data from participants who meet specific health criteria, ensuring that the reference values are accurate and applicable to the general population. The study focuses on individuals aged 18 and older who have no history of cardiovascular diseases or risk factors. The findings will help in evaluating cardiac health more effectively using MCG.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 years or older with no history of cardiovascular diseases or risk factors.

Not a fit: Patients with existing cardiovascular conditions or those on prescribed medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide essential reference values that enhance the accuracy of cardiac health assessments using magnetocardiography.

How similar studies have performed: While the approach of establishing reference intervals is common, the specific application of MCG in this context is relatively novel and has not been extensively tested.

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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Yuguo Chen, Professor — Qliu Hospital of Shandong University
• Study coordinator: Jiaojiao Pang, Doctor

Conditions MCG Reference Intervals Determination for Healthy Adults; Health, Subjective; Healthy Adults; Reference Intervals