Stable Coronary Artery DiseaseNCT06123728
MCG is Clinically Applied to Evaluate Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease
An observational study of Stable Coronary Artery Disease, run by Nanhai Hospital, Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The objective of this observational study is to evaluate the diagnostic effectiveness of magnetocardiography (MCG) in patients with stable coronary artery disease (SCAD) and compare it with coronary CTA (CCTA). Additionally, the study aims to determine the most suitable diagnostic index for MCG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease
- How many people
- 291 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2023to Feb 2026
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected stable coronary artery disease were enrolled in a consecutive group at Nanhai Hospital of Guangdong Provincial People's Hospital.
Who may be able to join
- Age ≥18 years old.
- Stable coronary artery disease patients with a coronary CTA stenosis degree of 30% to 90%.
- Sign informed consent.
Who cannot join
- Patients diagnosed with acute coronary syndrome.
- Patients diagnosed with hypertrophic cardiomyopathy.
- Patients diagnosed with dilated cardiomyopathy.
- Patients with complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, and complete bundle branch block.
- Patients with a left ventricular ejection fraction less than 50%.
- Patients with chronic obstructive pulmonary disease, heart failure, kidney failure, or other serious diseases.
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- Pregnant women.
- Patients with an allergy to contrast agents.
- The study subjects who have metal grafts that interfere with magnetic cardiogram examination.
- The study subjects who are unable to cooperate with magnetocardiogram examination and CTA.
- Patients who have undergone coronary artery bypass grafting.
- There are significant artifacts present in coronary CTA.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanhai Hospital, Guangdong Provincial People's Hospital
Foshan, Guangdong
Wenfei He, 13380239072, nh2y_xnk@163.com
Jishen Guo, 18027309031, guojsdoctor@163.com
About this study
Official title: The Clinical Application of Magnetocardiography (MCG) as a Non-invasive Diagnostic Tool for Evaluating Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease
The objective of this observational study is to evaluate the diagnostic effectiveness of magnetocardiography (MCG) in patients with stable coronary artery disease (SCAD) and compare it with coronary CTA (CCTA). Additionally, the study aims to determine the most suitable diagnostic index for MCG. The primary question it seeks to address is whether MCG or MCG combined with CCTA can be utilized to guide the clinical application of percutaneous coronary intervention (PCI) for coronary heart disease.
Read the detailed description
- Patients aged≥18 years with stable coronary artery disease (CCTA stenosis 30%-90%) underwent sequential examinations of MCG and CCTA. The results of CCTA were assessed using CT-FFR, and the diagnostic effectiveness of MCG in evaluating myocardial ischemia was analyzed using CT-FFR as the reference standard. Simultaneously, MCG was compared to CCTA to determine the clinical value of MCG in the functional evaluation of myocardial ischemia.
- Coronary angiography was performed in patients who met the criteria for the procedure, and revascularization was carried out based on the intraoperative situation. Patients who underwent revascularization were followed up for 1 year, with major adverse cardiovascular events (MACE) as the endpoint. The clinical value of MCG in guiding the treatment of patients with SCAD was evaluated by reviewing the proportion of coronary angiography, revascularization, and MACE in the enrolled patients.
- Conditions
- Stable Coronary Artery Disease
- Keywords
- stable coronary artery disease, magnetocardiography, coronary CTA
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency in comparing MCG and CT-FFR
Initially, MCG was conducted on each patient to assess the extent of myocardial ischemia using magnetic field distribution, pseudo-current density distribution, magnetic field intensity time spectrum line, and magnetic couple parameters. Simultaneously, the CT-FFR cut-off value of 0.8 was employed as the benchmark for this study. The agreement, sensitivity, specificity, and positive/negative predictive value of cardiac ischemia were compared between MCG and CT-FFR.
Measured: 1 year
Secondary outcomes (1)
Major Adverse Cardiac Events (MACE)
Firstly, we performed coronary angiography in the above patients who met the indications of coronary angiography and performed revascularization according to the intraoperative conditions. The revascularized patients were then followed up for 1 year with major adverse cardiovascular events as the endpoint. By reviewing the ratio of coronary angiography, revascularization, and incidence of MACE in enrolled patients, the value of MCG in guiding the clinical treatment of patients with stable coronary disease was evaluated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start19 Apr 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 291 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nanhai Hospital, Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123728
- Sponsor's protocol ID
- GJishen
- Status last verified
- Jun 2024
- First submitted
- 21 Oct 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Magnetocardiography (MCG) as a Non-invasive Diagnostic Tool for Evaluating Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06123728
- Acronym / sponsor ID
- GJishen
- Conditions
- Stable Coronary Artery Disease
- Keywords
- stable coronary artery disease, magnetocardiography, coronary CTA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Nanhai Hospital, Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 9 Nov 2023 (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 objective of this observational study is to evaluate the diagnostic effectiveness of magnetocardiography (MCG) in patients with stable coronary artery disease (SCAD) and compare it with coronary CTA (CCTA). Additionally, the study aims to determine the most suitable diagnostic index for MCG. The primary question it seeks to address is whether MCG or MCG combined with CCTA can be utilized to guide the clinical application of percutaneous coronary intervention (PCI) for coronary heart disease.
Detailed description
- Patients aged≥18 years with stable coronary artery disease (CCTA stenosis 30%-90%) underwent sequential examinations of MCG and CCTA. The results of CCTA were assessed using CT-FFR, and the diagnostic effectiveness of MCG in evaluating myocardial ischemia was analyzed using CT-FFR as the reference standard. Simultaneously, MCG was compared to CCTA to determine the clinical value of MCG in the functional evaluation of myocardial ischemia.
- Coronary angiography was performed in patients who met the criteria for the procedure, and revascularization was carried out based on the intraoperative situation. Patients who underwent revascularization were followed up for 1 year, with major adverse cardiovascular events (MACE) as the endpoint. The clinical value of MCG in guiding the treatment of patients with SCAD was evaluated by reviewing the proportion of coronary angiography, revascularization, and MACE in the enrolled patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected stable coronary artery disease were enrolled in a consecutive group at Nanhai Hospital of Guangdong Provincial People's Hospital.
Key inclusion criteria (3 listed)
- Age ≥18 years old.
- Stable coronary artery disease patients with a coronary CTA stenosis degree of 30% to 90%.
- Sign informed consent.
Key exclusion criteria (12 listed)
- Patients diagnosed with acute coronary syndrome.
- Patients diagnosed with hypertrophic cardiomyopathy.
- Patients diagnosed with dilated cardiomyopathy.
- Patients with complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, and complete bundle branch block.
- Patients with a left ventricular ejection fraction less than 50%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consistency in comparing MCG and CT-FFR
Time frame: 1 year
Initially, MCG was conducted on each patient to assess the extent of myocardial ischemia using magnetic field distribution, pseudo-current density distribution, magnetic field intensity time spectrum line, and magnetic couple parameters. Simultaneously, the CT-FFR cut-off value of 0.8 was employed as the benchmark for this study. The agreement, sensitivity, specificity, and positive/negative predictive value of cardiac ischemia were compared between MCG and CT-FFR.
1 secondary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
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 Stable Coronary Artery Disease, run by Nanhai Hospital, Guangdong Provincial People's Hospital 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 12 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 4 Jun 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 Wenfei He (13380239072, nh2y_xnk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency in comparing MCG and CT-FFR (time frame: 1 year). 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 4 Jun 2024.