MCG for Risk Stratifications of Patients With Chest Pain
August 29, 2024 updated by: Qilu Hospital of Shandong University
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）.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
3620
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiaojiao Pang, Doctor
- Phone Number: 0086-0531-82165674
- Email: jiaojiaopang@126.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital of Shandong University
-
Contact:
- Jiaojiao Pang, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patient who suffers from cardiogenic chest pain suspected with acute coronary syndrome （ACS）.
Description
Inclusion Criteria:
- Those with suspected ACS who presented with symptoms of acute chest pain.
- Signed informed consent.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Training and testing cohort
|
Magnetocardiography
|
|
External validation cohort
|
Magnetocardiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
from the date of enrollment until the date of discharge, up to 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yuguo Chen, Professor, Qliu Hospital of Shandong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2024
Primary Completion (Estimated)
October 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 11, 2024
First Submitted That Met QC Criteria
March 12, 2024
First Posted (Actual)
March 18, 2024
Study Record Updates
Last Update Posted (Actual)
September 3, 2024
Last Update Submitted That Met QC Criteria
August 29, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCG-chestpain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.