MCG Reference Intervals Determination for Healthy AdultsNCT06198777
Determination of MCG Reference Intervals in Healthy Individuals
An observational study of MCG Reference Intervals Determination for Healthy Adults and Health, Subjective, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MCG Reference Intervals Determination for Healthy Adults, Health, Subjective
- What is being tested?
- Magnetometer
- Type of treatment
- Medical device
- How many people
- 2,396 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults aged 18 years and older
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiaojiao Pang, Doctor, 0086-0531-82165674, jiaojiaopang@126.com
About this study
Official title: Establishing Reference Intervals for Magnetocardiography Parameters in Healthy Adults in China
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.
- Being tested
- Magnetometer
- Keywords
- Healthy Adults, Reference Intervals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetometerDevice
Inspection equipment for magnetocardiography
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Not described Receives: Device: Magnetometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
MCG device is used for the measurement of maximum current vector amplitude (pT/m) at the timepoint of R wave peak.
Measured: 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
MCG device is used for the measurement of total current vector angle at the timepoint of R wave peak.
Measured: 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
MCG device is used for the measurement of maximum current vector amplitude (pT/m) at the timepoint of T wave peak.
Measured: 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
MCG device is used for the measurement of total current vector angle at the timepoint of T wave peak.
Measured: from the date of enrollment until the date of the completion of all assessments, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start8 Jan 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCG Reference Intervals Determination for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- 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, Zhejiang University, School of Medicine, 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
- Investigators
- Yuguo Chen, Professor, Principal investigator, Qliu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198777
- Sponsor's protocol ID
- MCG-healthy
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Reference Intervals for Magnetocardiography Parameters in Healthy Adults in China
- ClinicalTrials.gov ID
- NCT06198777
- Acronym / sponsor ID
- MCG-healthy
- Keywords
- Healthy Adults, Reference Intervals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,396 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- 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, Zhejiang University, School of Medicine, 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
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Device: Magnetometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults aged 18 years and older
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnetometerInspection equipment for magnetocardiography | Device | Healthy adults |
Primary outcome
Reference value for NPM (physio-MCG parameter,%)
Time frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days
MCG device is used for the measurement of the physio-MCG parameter, and we will calculate the reference value.
4 secondary outcomes
Reference value for MCV (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
Reference value for TCV (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
Reference value for MCV (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
Reference value for TCV (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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuguo Chen, Professor principal investigator
Qliu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MCG Reference Intervals Determination for Healthy Adults and Health, Subjective, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaojiao Pang, Doctor (0086-0531-82165674, jiaojiaopang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference value for NPM (physio-MCG parameter,%) (time frame: from the date of enrollment until the date of the completion of all assessments, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.