Acute Coronary SyndromeNCT06316011
MCG for Risk Stratifications of Patients With Chest Pain
An observational study of Acute Coronary Syndrome, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS） using Magnetocardiography （MCG）. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Magnetocardiography
- Type of treatment
- Medical device
- How many people
- 3,620 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient who suffers from cardiogenic chest pain suspected with acute coronary syndrome （ACS）.
Who may be able to join
- Those with suspected ACS who presented with symptoms of acute chest pain.
- Signed informed consent.
Who cannot join
- Those with known structural heart disease such as cardiomyopathy and valvular disease;
- Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal;
- Those who have chest pain with known pulmonary embolism or aortic coarctation;
- Those who are thought to be incapable of completing the MCG examination by an attending physician (or physician with higher qualifications) due to unstable clinical conditions, metal implants, etc;
- Those who are unable to perform magnetocardiography examinations due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
- Those with malignant tumors;
- Pregnant or lactating women.
- Those with acute or critical illnesses of other systems, such as acute or severe respiratory illnesses, marked abnormalities in liver function or kidney function.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiaojiao Pang, Doctor
About this study
Official title: Magnetocardiography in the Identification and Risk Stratification of Patients With Acute Chest Pian
This prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS） using Magnetocardiography （MCG）.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Magnetocardiography
- Medical subject headings
- Acute Coronary Syndrome
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 for the detection and risk stratification in high-risk patients with chest pain
Establishing an algorithm model of MCG in identifying high-risk cardiogenic chest pain, the efficacy of the model was assessed by sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and AUC, etc.
Measured: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG for the detection and risk stratification in low-risk patients with chest pain
Establishing an algorithm model of MCG in identifying low-risk cardiogenic chest pain, the efficacy of the model was assessed by sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and AUC, etc.
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 posted18 Mar 2024
- Study start20 Mar 2024
- Primary completion30 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 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
- 3,620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Emergency Medical Center, Weifang People's Hospital, Linyi People's Hospital, Weihai Central Hospital, Jining First People's 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, 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
- NCT06316011
- Sponsor's protocol ID
- MCG-chestpain
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetocardiography in the Identification and Risk Stratification of Patients With Acute Chest Pian
- ClinicalTrials.gov ID
- NCT06316011
- Acronym / sponsor ID
- MCG-chestpain
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,620 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Chongqing Emergency Medical Center, Weifang People's Hospital, Linyi People's Hospital, Weihai Central Hospital, Jining First People's 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, Guangdong Provincial Hospital of Traditional Chinese Medicine, Qianfoshan Hospital, Heze Municipal Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Mar 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 prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS） using Magnetocardiography （MCG）.
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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient who suffers from cardiogenic chest pain suspected with acute coronary syndrome （ACS）.
Key inclusion criteria (2 listed)
- Those with suspected ACS who presented with symptoms of acute chest pain.
- Signed informed consent.
Key exclusion criteria (8 listed)
- Those with known structural heart disease such as cardiomyopathy and valvular disease;
- Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal;
- Those who have chest pain with known pulmonary embolism or aortic coarctation;
- Those who are thought to be incapable of completing the MCG examination by an attending physician (or physician with higher qualifications) due to unstable clinical conditions, metal implants, etc;
- Those who are unable to perform magnetocardiography examinations due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
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 for the detection and risk stratification in high-risk patients with chest pain
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Establishing an algorithm model of MCG in identifying high-risk cardiogenic chest pain, the efficacy of the model was assessed by sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and AUC, etc.
Efficacy of MCG for the detection and risk stratification in low-risk patients with chest pain
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Establishing an algorithm model of MCG in identifying low-risk cardiogenic chest pain, the efficacy of the model was assessed by sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and AUC, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 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 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 2 inclusion and 8 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 3 Sep 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 (0086-0531-82165674, 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 for the detection and risk stratification in high-risk patients with chest pain (time frame: from the date of enrollment until the date of discharge, up to 30 days). The study lists 2 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 3 Sep 2024.