Chest PainNCT06255769
Diagnosis of Myocardial Ischemia With MCG Using SPECT as a Reference Standard
An observational study of Chest Pain and Stenosis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is a prospective clinical study aiming to investigate the efficacy of Magnetocardiography (MCG) in detecting myocardial ischemia in patients of a suspected non-ST-elevation-acute coronary syndrome (NSTE-ACS) by using Single photon emission computed tomography (SPECT) as the gold standard for determining the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Stenosis, Myocardial Ischemia
- What is being tested?
- Magnetocardiography and Single photon emission computed tomography (SPECT)
- Type of treatment
- Medical device
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2024to 31 Dec 2024
- 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: Chest pain patients who have CAG showing <70% stenosis at the most severe site or CTA showing non-severe stenosis
Who may be able to join
- Age 18 years or older;
- Patients with symptoms of myocardial ischemia such as angina pectoris, who have CAG showing <70% stenosis at the most severe site or CTA showing non-severe stenosis
- Signed informed consent.
Who cannot join
- Patients with absolute or relative contraindications to SPECT-loaded myocardial perfusion, including acute myocardial infarction within 48 hours, significant left main coronary artery stenosis, bronchial asthma, and adenosine injection allergy;
- 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, Ⅱdegree 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.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
YUGUO CHEN
About this study
Official title: Identification of Myocardial Ischemia With Magnetocardiography Using Single Photon Emission Computed Tomography (SPECT) as a Reference Standard
This is a prospective clinical study aiming to investigate the efficacy of Magnetocardiography (MCG) in detecting myocardial ischemia in patients of a suspected non-ST-elevation-acute coronary syndrome (NSTE-ACS) by using Single photon emission computed tomography (SPECT) as the gold standard for determining the presence and severity of myocardial ischemia.
- Conditions
- Chest Pain, Stenosis, Myocardial Ischemia
- Being tested
- Magnetocardiography, Single photon emission computed tomography (SPECT)
- Medical subject headings
- Chest Pain, Constriction, Pathologic, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetocardiographyDevice
Magnetocardiography
Single photon emission computed tomography (SPECT)Device
Single photon emission computed tomography (SPECT)
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.
Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.
Measured: from the date of enrollment until the date of discharge, up to 30 days
Secondary outcomes (1)
Efficacy of MCG to detect myocardial ischemia in patients with coronary stenosis <50% (Ischemia with no obstructive coronary artery, INOCA)
Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.
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 posted13 Feb 2024
- Study start12 Feb 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Emergency Medical Center
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Professor, Principal investigator, Qliu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255769
- Sponsor's protocol ID
- MCG-SPECT
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2024
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Myocardial Ischemia With Magnetocardiography Using Single Photon Emission Computed Tomography (SPECT) as a Reference Standard
- ClinicalTrials.gov ID
- NCT06255769
- Acronym / sponsor ID
- MCG-SPECT
- Conditions
- Chest Pain, Stenosis, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Chongqing Emergency Medical Center
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Feb 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 a prospective clinical study aiming to investigate the efficacy of Magnetocardiography (MCG) in detecting myocardial ischemia in patients of a suspected non-ST-elevation-acute coronary syndrome (NSTE-ACS) by using Single photon emission computed tomography (SPECT) as the gold standard for determining the presence and severity of myocardial ischemia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chest pain patients who have CAG showing <70% stenosis at the most severe site or CTA showing non-severe stenosis
Key inclusion criteria (3 listed)
- Age 18 years or older;
- Patients with symptoms of myocardial ischemia such as angina pectoris, who have CAG showing <70% stenosis at the most severe site or CTA showing non-severe stenosis
- Signed informed consent.
Key exclusion criteria (7 listed)
- Patients with absolute or relative contraindications to SPECT-loaded myocardial perfusion, including acute myocardial infarction within 48 hours, significant left main coronary artery stenosis, bronchial asthma, and adenosine injection allergy;
- 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, Ⅱdegree 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 | – |
| Single photon emission computed tomography (SPECT)Single photon emission computed tomography (SPECT) | Device | – |
Primary outcome
Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.
1 secondary outcome
Efficacy of MCG to detect myocardial ischemia in patients with coronary stenosis <50% (Ischemia with no obstructive coronary artery, INOCA)
Time frame: from the date of enrollment until the date of discharge, up to 30 days
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?
An observational study of Chest Pain and Stenosis, 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: 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 myocardial ischemia using SPECT as a reference standard. (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 21 Aug 2024.