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RecruitingNCT05392712Updated Aug 22, 2024

Magnetocardiography in the Accurate Identification of Severe Coronary Lesions and Myocardial Necrosis

An interventional study of Magnetometer in Chest Pain, Acute Coronary Syndrome, Myocardial Infarction, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
430
Allocation
Non-randomized
Ages
18 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Chest Pain with a site in China — 7 open to participants now, 7 under way, none of them phase 3. Chest Pain · China.

Started
2022
with 2 others
No phase
6 of 17
2 open now
Registered
9th of 17
by date
Lead sponsor
5 of 17
Qilu Hospital of Shandong University

Among the 17 studies in Chest Pain with a site in China, this one is one of 3 that started in 2022, is one of 6 with no phase, and was the 9th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

Observational9 · 4 open
No phasethis study6 · 2 open
Phase 1/21 · 1 open
Phase 41 · 0 open

By the year they started

First in 2002; this study’s year is marked. 3 started in 2022.

Size and results

Median enrollment 226 across the 8 interventional studies, 3,841 across the 9 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.

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02

Study summary

Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting myocardial ischemia. Although progress has been made in this area, there is a lack of studies using up-to-date examination instruments for the calibration of MCG analysis. This is a prospective single-center study aiming to build accurate analytical models of MCG to detect coronary lesions and myocardial necrosis. Coronary lesions are measured by coronary angiography (CAG) or coronary CTA, and are defined by both the stenosis degree and the computer-simulated fraction flow reserve. Myocardial necrosis is examined and quantified by cardiac MR. Healthy volunteers, chest pain patients who will receive CAG or CTA examination, and patients with acute myocardial infarction will be enrolled in this study.

03

Conditions studied

  • Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

For healthy volunteers:

Inclusion Criteria:

  1. Age 18-79 years old;
  2. No history of cardiovascular disease (coronary heart disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic dissection, etc.), no cardiovascular risk factors (hypertension, diabetes, hyperlipidemia). For people over 65 years old, those with hypertension or hyperlipidemia, but with well-controlled blood pressure and lipid levels, taking no more than 2 drugs, and echocardiography showing no left ventricular hypertrophy, can be included;
  3. The is normal, and the cardiac ultrasound is basically normal in the past 1 year (mild valvular regurgitation can be included).
  4. Sign the .

Exclusion Criteria:

  1. Those who with acute or chronic respiratory diseases;
  2. Those who with obvious abnormality of liver or kidney function;
  3. Those who with endocrine diseases such as abnormal thyroid function;
  4. Those who with anemia or other blood diseases;
  5. Those who with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.);
  6. Those who are obese (>30kg/cm2) or underweight (BMI\<18kg/cm2);
  7. Those who with malignant tumors;
  8. Those who with infectious diseases or infectious diseases;
  9. Those who with trauma or physical disability;
  10. Those who with psychological or mental illness such as depression;
  11. Those who are professional athletes, pregnant or breastfeeding women, alcoholics;
  12. Those who are unable to perform magnetocardiography examination due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
  13. Due to various reasons such as allergy to contrast agents, metal implants in vivo that are prohibited from performing 1.5T MRI (such as prostheses or steel plates implanted in orthopaedics, uterine device) and other reasons, those who cannot or fail to cooperate with the corresponding research requirements.

For chest pain patients who will undergo CAG or CTA:

Inclusion Criteria:

  1. Age 18-79 years old;
  2. Those with chest pain symptoms, diagnosed or highly suspected by the attending doctor or above as stable angina pectoris (SA), unstable angina pectoris (UA), non-ST segment elevation myocardial infarction (NSTEMI), ST segment elevation myocardial infarction (STEMI), and plan to receive CAG or coronary CTA;
  3. Sign the informed consent.

Exclusion Criteria:

  1. Patients with known structural heart disease such as cardiomyopathy and valvular disease;
  2. Patients with arrhythmias such as atrial fibrillation, supraventricular tachycardia, and atrioventricular block that have not returned to normal;
  3. History of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
  4. Patients with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
  5. Obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
  6. Obese (BMI>30kg/cm2) or underweight (BMI\<18kg/cm2);
  7. Patients with malignant tumors;
  8. Professional athletes, pregnant or breastfeeding women, alcoholics;
  9. Acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
  10. Patients with infectious diseases or infectious diseases;
  11. Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
  12. Unable to or fail to cooperate with the corresponding research requirements.

For AMI patients:

Inclusion Criteria:

  1. Age 18-79 years old;
  2. The attending doctor or above has diagnosed the patient as acute myocardial infarction (NSTEMI, STEMI), the condition of whom is relatively stable, and CMR examination is feasible after evaluation.
  3. Sign the informed consent.

Exclusion Criteria:

  1. Patients with known structural heart disease such as cardiomyopathy and valvular disease;
  2. Patients with arrhythmias such as atrial fibrillation, supraventricular tachycardia, and atrioventricular block that have not returned to normal;
  3. History of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
  4. Patients with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
  5. Obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
  6. Obese (BMI>30kg/cm2) or underweight (BMI\<18kg/cm2);
  7. Patients with malignant tumors;
  8. Professional athletes, pregnant or breastfeeding women, alcoholics;
  9. Acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
  10. Patients with infectious diseases or infectious diseases;
  11. Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
  12. Due to various reasons such as allergy to contrast agents, metal implants in vivo that are prohibited from performing 1.5T MRI (such as prostheses or steel plates implanted in orthopaedics, uterine contraceptive device) and other reasons, those who cannot or fail to cooperate with the corresponding research requirements.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
430 participants (estimated)

Study arms

  • Other
    healthy volunteers

    Device: Magnetometer

  • Experimental
    Chest pain patients who will undergo CAG or CTA

    Device: Magnetometer

  • Experimental
    AMI patients

    Device: Magnetometer

Interventions

  • DeviceMagnetometer

    inspection equipment for magnetocardiography

06

What researchers measure

Primary outcomes

  1. Accuracy of MCG to detect coronary lesion

    To establish an algorithm model of MCG in detecting coronary lesion and to assess the sensitivity and specificity of the above model in detecting coronary lesion. Coronary lesion is measured by degree of stenosis via CAG/CTA and computer-simulated fraction flow reserve via QFR/CTFFR.

    Time frame: 24 hours

  2. Accuracy of MCG to detect myocardial necrosis

    To establish an algorithm model of MCG in detecting myocardial necrosis and to assess the sensitivity and specificity of this model in detecting myocardial necrosis, which is measured via cardiac MR.

    Time frame: 24 hours

Secondary outcomes

  1. Accuracy of MCG to detect the localization of coronary lesion

    To build up an algorithm model of MCG in detecting the localization of coronary lesion. Assess the sensitivity and specificity of this model to detect the main vessels where the lesion locates.

    Time frame: 24 hours

  2. Accuracy of MCG to detect the zone of myocardial necrosis

    To establish an algorithm model of MCG to detect the infarct zone of the heart. Assess the sensitivity and specificity of this model to detect the location of myocardial necrosis.

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Aug 2024, 27 months after the start.

Of 84 non-industry interventional studies with no phase under Chest Pain, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 27 months is above that.

Counting every sponsor, half of 86 studies reached it within 23 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2022
First posted
May 26, 2022
StartActual
May 30, 2022
Primary completionEst.
Aug 30, 2024
CompletionEst.
Dec 30, 2024
Last update
Aug 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05392712
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Weifang People's Hospital, Linyi People's Hospital, Jining First People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, First Affiliated Hospital Xi'an Jiaotong University, Chongqing Emergency Medical Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, First People's Hospital of Hangzhou, Qianfoshan Hospital, Weihai Central Hospital, Heze Municipal Hospital
Responsible party
Sponsor
First posted
May 26, 2022
Start date
May 30, 2022
Primary completion
Aug 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Aug 22, 2024

Study contacts

Jiaojiao Pang, Dr.
Contact
jiaojiaopang@126.com
0086-0531-82165674
Yuguo Chen, Dr
principal investigator · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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