TachyarrhythmiaNCT06327425
MCG for Localization of Tachyarrhythmia's Origin
A study testing Magnetocardiography in people with Tachyarrhythmia and Atrial Flutter, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Tachyarrhythmia, Atrial Flutter, Paroxysmal Supraventricular Tachycardia
- What is being tested?
- Magnetocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to Feb 2025
- Phase
- Interventional
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-79 years old;
- Those whose conditions are comparatively stable and who have been diagnosed by an attending physician （or physicians with higher qualifications） with paroxysmal supraventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation, or premature ventricular contractions, and who are capable of performing MCG and cardiac electrophysiologic examinations after evaluation.
- Signed informed consent.
Who cannot join
- Those with known structural heart disease such as cardiomyopathy and valvular disease;
- Those with history of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
- Those with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
- Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
- Those with Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
- Those with malignant tumors;
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- Professional athletes, pregnant or breastfeeding women, alcoholics;
- Those with acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
- Those with infectious diseases or communicable diseases;
- Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
- Unable to or fail to cooperate with the corresponding research requirements.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Shandong Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiaojiao Pang, Doctor, 0086-0531-82165398, jiaojiaopang@126.com
About this study
Official title: Magnetocardiography for Precise Identification of the Site of Origin of Tachyarrhythmia
This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation.
- Conditions
- Tachyarrhythmia, Atrial Flutter, Paroxysmal Supraventricular Tachycardia, Atrial Tachycardia, Atrial Fibrillation, Premature Ventricular Contraction
- Being tested
- Magnetocardiography
- Medical subject headings
- Tachycardia, Atrial Flutter, Tachycardia, Ventricular, Atrial Fibrillation, Ventricular Premature Complexes
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 |
|---|---|---|
| Patients with atrial tachycardia | Experimental | Patients with atrial tachycardia will receive dynamic ECG, MCG and cardiac electrophysiologic examinations. Receives: Device: Magnetocardiography |
| Patients with atrial flutter | Experimental | Patients with atrial flutter will receive dynamic ECG, MCG and cardiac electrophysiologic examinations. Receives: Device: Magnetocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard.
Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.
Measured: 12 month course of the disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start14 Mar 2024
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 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
- NCT06327425
- Sponsor's protocol ID
- MCG-Tachyarrhythmia
- 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
- Magnetocardiography for Precise Identification of the Site of Origin of Tachyarrhythmia
- ClinicalTrials.gov ID
- NCT06327425
- Acronym / sponsor ID
- MCG-Tachyarrhythmia
- Conditions
- Tachyarrhythmia, Atrial Flutter, Paroxysmal Supraventricular Tachycardia, Atrial Tachycardia, Atrial Fibrillation, Premature Ventricular Contraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 25 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.
This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with atrial tachycardia | Experimental | Device: MagnetocardiographyPatients with atrial tachycardia will receive dynamic ECG, MCG and cardiac electrophysiologic examinations. |
| Patients with atrial flutter | Experimental | Device: MagnetocardiographyPatients with atrial flutter will receive dynamic ECG, MCG and cardiac electrophysiologic examinations. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-79 years old;
- Those whose conditions are comparatively stable and who have been diagnosed by an attending physician （or physicians with higher qualifications） with paroxysmal supraventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation, or premature ventricular contractions, and who are capable of performing MCG and cardiac electrophysiologic examinations after evaluation.
- Signed informed consent.
Key exclusion criteria (11 listed)
- Those with known structural heart disease such as cardiomyopathy and valvular disease;
- Those with history of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
- Those with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
- Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
- Those with Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
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 | Patients with atrial flutter, Patients with atrial tachycardia |
Primary outcome
Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard.
Time frame: 12 month course of the disease
Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.
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?
A study testing Magnetocardiography in people with Tachyarrhythmia and Atrial Flutter, 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 3 inclusion and 11 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 (0086-0531-82165398, jiaojiaopang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard. (time frame: 12 month course of the disease). 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.