Structural Heart AbnormalityNCT06315998
Diagnosis of Structural Heart Disease Using MCG
An observational study of Structural Heart Abnormality, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Structural Heart Abnormality
- What is being tested?
- Magnetocardiography
- Type of treatment
- Medical device
- How many people
- 2,914 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2024to 30 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected structural heart disease who are scheduled to undergo echocardiography or cardiac magnetic resonance
Who may be able to join
- Those with suspected structural heart disease who are scheduled to undergo echocardiography or cardiac magnetic resonance. Structural heart disease includes cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, etc.), congenital heart disease (including ventricular septal defect, atrial septal defect, patent ductus arteriosus, Tetralogy of Fallot) syndrome, tricuspid valve malformation, etc.), valvular heart disease (aortic valve stenosis, mitral valve stenosis, etc.), ventricular remodeling caused by myocardial ischemia or cardiac structural changes.
- Signed the consent form.
Who cannot join
- Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal;
- Those who are thought to be incapable of completing the relevant examinations by an attending physicians (or physicians with higher qualifications) due to unstable clinical conditions, metal implants, etc., or those who are unable to perform the examinations;
- Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
- Those with malignant tumors;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Shandong Qilu Hospital of Shandong University
Jinan, Shandong, 250012
About this study
Official title: Accurate Identification of Structural Heart Disease Using Magnetocardiography as an Innovative and Non-invasive Tool
The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard.
- Conditions
- Structural Heart Abnormality
- Being tested
- Magnetocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetocardiographyDevice
Magnetocardiography
| Study group | Role | What they receive |
|---|---|---|
| Training and testing cohort | Not described Receives: Device: Magnetocardiography | |
| External validation cohort | Not described Receives: Device: Magnetocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of the MCG in identifying structural heart disease
Using echocardiography or cardiac magnetic resonance as reference standard to assess the sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and ROC of the cardiac magnetic image algorithm model for identification and localization of structural heart disease.
Measured: from the date of enrollment until the date of discharge, 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 posted18 Mar 2024
- Study start18 Mar 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart AbnormalityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,914 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Professor, Principal investigator, Qliu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315998
- Sponsor's protocol ID
- MCG-Structural
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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
- Accurate Identification of Structural Heart Disease Using Magnetocardiography as an Innovative and Non-invasive Tool
- ClinicalTrials.gov ID
- NCT06315998
- Acronym / sponsor ID
- MCG-Structural
- Conditions
- Structural Heart Abnormality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,914 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Mar 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.
The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training and testing cohort | – | Device: Magnetocardiography |
| External validation cohort | – | Device: Magnetocardiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected structural heart disease who are scheduled to undergo echocardiography or cardiac magnetic resonance
Key inclusion criteria (2 listed)
- Those with suspected structural heart disease who are scheduled to undergo echocardiography or cardiac magnetic resonance. Structural heart disease includes cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, etc.), congenital heart disease (including ventricular septal defect, atrial septal defect, patent ductus arteriosus, Tetralogy of Fallot) syndrome, tricuspid valve malformation, etc.), valvular heart disease (aortic valve stenosis, mitral valve stenosis, etc.), ventricular remodeling caused by myocardial ischemia or cardiac structural changes.
- Signed the consent form.
Key exclusion criteria (5 listed)
- Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal;
- Those who are thought to be incapable of completing the relevant examinations by an attending physicians (or physicians with higher qualifications) due to unstable clinical conditions, metal implants, etc., or those who are unable to perform the examinations;
- Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
- Those with malignant tumors;
- Pregnant or lactating women.
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 |
|---|---|---|
| MagnetocardiographyMagnetocardiography | Device | External validation cohort, Training and testing cohort |
Primary outcome
The efficacy of the MCG in identifying structural heart disease
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Using echocardiography or cardiac magnetic resonance as reference standard to assess the sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and ROC of the cardiac magnetic image algorithm model for identification and localization of structural heart disease.
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.
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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 Structural Heart Abnormality, 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 2 inclusion and 5 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 (0086-0531-82165398, jiaojiaopang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the MCG in identifying structural heart disease (time frame: from the date of enrollment until the date of discharge, 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.