Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial IschemiaNCT05718206
Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography
A study testing Magnetocardiography in people with Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia, run by Xiangya Hospital of Central South University.
Trial summary
Magnetocardiography (MCG) is a non-invasive and accurate method of detecting myocardial ischemia. However, the previous MCG is limited in clinical practice due to its high working conditions and limited sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
- What is being tested?
- Magnetocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2023to 14 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Those who are suspected of coronary heart disease and scheduled to undergo coronary angiography;
- Sign the informed consent.
Who cannot join
- Complex arrhythmia, including frequent premature atrial beats, premature ventricular beats, atrial fibrillation, atrial flutter, and complete bundle branch block;
- Severe hypertension (> 180/110 mmHg);
- Congenital heart diseases, valvular heart diseases, or implantation of pacemakers or drug pumps.
- Severe thoracic or pulmonary diseases, thoracic malformation, or history of thoracic surgery;
- Pregnant or breastfeeding women;
- Claustrophobia, or those who can't lie still for 2 minutes in a confined space;
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- Allergy to contrast agent;
- Renal impairment: serum creatinine > 2,0 mg/dl (176.8 μmol/L) or those who are receiving hemodialysis;
- Other diseases, including malignant tumors, organ transplantation, and candidates for organ transplantation;
- History of alcohol or drug abuse (cocaine, heroin, etc.);
- Participating in clinical studies of other drugs or devices without reaching the time limit for the primary endpoint;
- Those who aren't suitable for inclusion due to other reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on Diagnosis and Prognosis of Myocardial Ischemia Level in Xiangya Hospital Using Magnetocardiography -- Miracle MCG
Magnetocardiography (MCG) is a non-invasive and accurate method of detecting myocardial ischemia. However, the previous MCG is limited in clinical practice due to its high working conditions and limited sensitivity. The next-generation MCG based on optical pumped magnetometer (OPM) has the advantages of high sensitivity, high reliability, high usability and low cost, which makes it suitable for most medical scenarios. Thus, this prospective single-center study aimed to use OPM MCG to explore its diagnostic efficacy and predictive value for myocardial ischemia. Participants who will receive coronary angiography examinations will be enrolled in this study. Participants enrolled in the study will also have a 1, 3, 6, 12, 24, 36, and 48-month follow-up for analysis of adverse cardiac events.
- Conditions
- Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
- Being tested
- Magnetocardiography
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetocardiographyDevice
Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.
| Study group | Role | What they receive |
|---|---|---|
| Coronary stenosis | Experimental | Not described Receives: Device: Magnetocardiography |
| Control | Other | Not described Receives: Device: Magnetocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of diagnosis of myocardial infarction level
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the sensitivity to evaluate the diagnosis of myocardial infarction level validity.
Measured: up to 6 months
Specificity of diagnosis of myocardial infarction level
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the specificity to evaluate the diagnosis of myocardial infarction level validity.
Measured: up to 6 months
Consistency of diagnosis of myocardial infarction level
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the consistency to evaluate the diagnosis of myocardial infarction level reliability.
Measured: up to 6 months
Kappa statistics of diagnosis of myocardial infarction level
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the Kappa statistics to evaluate the diagnosis of myocardial infarction level reliability.
Measured: up to 6 months
Secondary outcomes (1)
Incidence of major adverse cardiovascular events
Participants are followed up by telephone at 1, 3, 6, 12, 24, 36, 48, and 60 months after recruitment and ask whether major adverse cardiac events (MACE) have happened. MACE will be defined as acute myocardial infarction, coronary revascularization, stroke, and all-cause death. According to incidence of MACE, draw the Kaplan-Meier curve and establish Cox regression model.Establish a risk-predicted model of MCG for detecting myocardial infarction
Measured: through study completion, an avarage of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion14 Aug 2023 (estimated)
- Study completion14 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718206
- Sponsor's protocol ID
- 202209584
- Status last verified
- Dec 2022
- First submitted
- 25 Dec 2022
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Diagnosis and Prognosis of Myocardial Ischemia Level in Xiangya Hospital Using Magnetocardiography -- Miracle MCG
- ClinicalTrials.gov ID
- NCT05718206
- Acronym / sponsor ID
- 202209584
- Conditions
- Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 14 Aug 2023 (estimated)
- Study completion
- 14 Aug 2025 (estimated)
- First posted
- 8 Feb 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.
Magnetocardiography (MCG) is a non-invasive and accurate method of detecting myocardial ischemia. However, the previous MCG is limited in clinical practice due to its high working conditions and limited sensitivity. The next-generation MCG based on optical pumped magnetometer (OPM) has the advantages of high sensitivity, high reliability, high usability and low cost, which makes it suitable for most medical scenarios. Thus, this prospective single-center study aimed to use OPM MCG to explore its diagnostic efficacy and predictive value for myocardial ischemia. Participants who will receive coronary angiography examinations will be enrolled in this study. Participants enrolled in the study will also have a 1, 3, 6, 12, 24, 36, and 48-month follow-up for analysis of adverse cardiac events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary stenosis | Experimental | Device: Magnetocardiography |
| Control | Other | Device: Magnetocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- Those who are suspected of coronary heart disease and scheduled to undergo coronary angiography;
- Sign the informed consent.
Key exclusion criteria (12 listed)
- Complex arrhythmia, including frequent premature atrial beats, premature ventricular beats, atrial fibrillation, atrial flutter, and complete bundle branch block;
- Severe hypertension (> 180/110 mmHg);
- Congenital heart diseases, valvular heart diseases, or implantation of pacemakers or drug pumps.
- Severe thoracic or pulmonary diseases, thoracic malformation, or history of thoracic surgery;
- Pregnant or breastfeeding 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 |
|---|---|---|
| MagnetocardiographyBoth arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently. | Device | Control, Coronary stenosis |
Primary outcome
Sensitivity of diagnosis of myocardial infarction level
Time frame: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the sensitivity to evaluate the diagnosis of myocardial infarction level validity.
Specificity of diagnosis of myocardial infarction level
Time frame: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the specificity to evaluate the diagnosis of myocardial infarction level validity.
Consistency of diagnosis of myocardial infarction level
Time frame: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the consistency to evaluate the diagnosis of myocardial infarction level reliability.
Kappa statistics of diagnosis of myocardial infarction level
Time frame: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the Kappa statistics to evaluate the diagnosis of myocardial infarction level reliability.
1 secondary outcome
Incidence of major adverse cardiovascular events
Time frame: through study completion, an avarage of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetocardiography in people with Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia, run by Xiangya Hospital of Central South University.
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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Jie Liu (86-18932462423, 208111002@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of diagnosis of myocardial infarction level (time frame: up to 6 months). The study lists 4 primary outcomes in all. 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 8 Feb 2023.