Non ST Segment Elevation Acute Coronary SyndromeNCT06197724
MCG for Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients
An observational study of Non ST Segment Elevation Acute Coronary Syndrome, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- Magnetocardiography
- Type of treatment
- Medical device
- How many people
- 14,090 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: chest pain patients with suspected NSTE-ACS
Who may be able to join
- Age 18 years or older;
- Patients with symptoms of myocardial ischemia such as angina who are suspected to NSTE-ACS and proposed to undergo CAG or coronary CTA;
- Signed informed consent.
Who cannot join
- Patients with ST-elevation myocardial infarction (STEMI);
- Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
- Patients with Hemodynamic instability (systolic blood pressure<90 mmHg, or who requires vasoactive drugs), or patients with tachyarrhythmia, Ⅱ degree atrioventricular block and above that have not returned to normal;
- Patients who have severe renal abnormality with eGFR <30 ml/min, or patients who are on dialysis;
- Patients with malignant tumors with predicted survival of less than 1 year;
- Pregnant or breastfeeding women;
- Patients who are unable to enter the MCG device, who are unable to perform MCG examination due to interference from metal implants or other reasons, or who are deemed by the investigators to be unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiaojiao Pang, Doctor, 0086-0531-82165398, jiaojiaopang@126.com
About this study
Official title: Magnetocardiography as an Innovative Diagnostic Tool for Early and Accurate Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients
The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.
Read the detailed description
Rapid and accurate Identification of ischemia in patients with chest pain suspected of non-ST-elevation-acute coronary syndrome (NSTE-ACS) is of great clinical significance for timely and effective treatment. Magnetocardiography based on spin-exchange relaxation-free (SERF) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. Magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (MCG) contains more information of diagnostic value of ischemia. The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.
- 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.
Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS
the sensitivity and specificity of MCG to detect coronary ischemia (defined as stenosis ≥ 90% or fractional flow reserve ≤0.8）
Measured: from the date of enrollment until the date of discharge, up to 30 days
Secondary outcomes (4)
Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.
A normal ECG is determined by two cardiologists with over five years of working experience. If there is any objection, the decision shall be made by a third cardiologist of the same qualifications or above. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.
Measured: from the date of enrollment until the date of discharge, up to 30 days
The time saved by using MCG in the detection of NSTEMI compared to troponin
The time for the detection of NSTEMI is from the timepoint of first medical contact to the timepoint of MCG report showing ischemia or the first report of troponin that over the 99th percentile of the Upper reference limit (URL).
Measured: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in evaluating the severity of coronary lesions.
The severity of coronary lesions is determined by using CAG/CTA and fractional flow reserve. Severe degree is defined as ≥90% stenosis of at least one main vessel or branch vessel with diameter ≥2mm. Moderate degree is defined as 50%-89% stenosis and fractional flow reserve ≤0.8. Mild degree is defined as <50% stenosis and fractional flow reserve ≤0.8, or stenosis 50%-89% and fractional flow reserve> 0.8. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.
Measured: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in early stratification of patients with suspected NSTE-ACS
For early stratification measurement, patients with suspected NSTE-ACS are assessed by 30d (from enrollment) MACE and classified as high or low risk. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy of MCG.
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 posted9 Jan 2024
- Study start2 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies 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
- 14,090 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, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Hangzhou, Chongqing Emergency Medical Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, Qianfoshan Hospital, Heze Municipal Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Professor, Principal investigator, Qliu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197724
- Sponsor's protocol ID
- MCG-NSTEACS
- Status last verified
- Sep 2025
- First submitted
- 11 Dec 2023
- Last updated
- 29 Sep 2025
- 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetocardiography as an Innovative Diagnostic Tool for Early and Accurate Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients
- ClinicalTrials.gov ID
- NCT06197724
- Acronym / sponsor ID
- MCG-NSTEACS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 14,090 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, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Hangzhou, Chongqing Emergency Medical Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, Qianfoshan Hospital, Heze Municipal Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 9 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.
The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.
Detailed description
Rapid and accurate Identification of ischemia in patients with chest pain suspected of non-ST-elevation-acute coronary syndrome (NSTE-ACS) is of great clinical significance for timely and effective treatment. Magnetocardiography based on spin-exchange relaxation-free (SERF) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. Magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (MCG) contains more information of diagnostic value of ischemia. The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.
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
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chest pain patients with suspected NSTE-ACS
Key inclusion criteria (3 listed)
- Age 18 years or older;
- Patients with symptoms of myocardial ischemia such as angina who are suspected to NSTE-ACS and proposed to undergo CAG or coronary CTA;
- Signed informed consent.
Key exclusion criteria (7 listed)
- Patients with ST-elevation myocardial infarction (STEMI);
- Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
- Patients with Hemodynamic instability (systolic blood pressure<90 mmHg, or who requires vasoactive drugs), or patients with tachyarrhythmia, Ⅱ degree atrioventricular block and above that have not returned to normal;
- Patients who have severe renal abnormality with eGFR <30 ml/min, or patients who are on dialysis;
- Patients with malignant tumors with predicted survival of less than 1 year;
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
Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS
Time frame: from the date of enrollment until the date of discharge, up to 30 days
the sensitivity and specificity of MCG to detect coronary ischemia (defined as stenosis ≥ 90% or fractional flow reserve ≤0.8）
4 secondary outcomes
Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.
Time frame: from the date of enrollment until the date of discharge, up to 30 days
The time saved by using MCG in the detection of NSTEMI compared to troponin
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in evaluating the severity of coronary lesions.
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in early stratification of patients with suspected NSTE-ACS
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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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.
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 Non ST Segment Elevation Acute Coronary Syndrome, 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 7 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 coronary ischemia in patients with suspected NSTE-ACS (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 29 Sep 2025.