MCG for Risk Stratifications of Patients With Chest Pain

NCT06316011 | Recruiting

• 1 other identifier: MCG-chestpain
• Study Type: observational
• Target: 3,620
• Locations: 1 country
• Sites: 1

Brief 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）.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  from the date of enrollment until the date of discharge, up to 30 days

Study Arms (2)

Training and testing cohort

Device: Magnetocardiography

External validation cohort

Device: Magnetocardiography

Interventions

Magnetocardiography DEVICE

Magnetocardiography

External validation cohort; Training and testing cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient who suffers from cardiogenic chest pain suspected with acute coronary syndrome （ACS）.

You may qualify if:

• Those with suspected ACS who presented with symptoms of acute chest pain.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Chongqing Emergency Medical Center: collaborator
• Weifang People's Hospital: collaborator
• Linyi People's Hospital: collaborator
• Weihai Central Hospital: collaborator
• Jining First People's Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• First People's Hospital of Hangzhou: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Qianfoshan Hospital: collaborator
• Heze Municipal Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Magnetocardiography

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Study Officials

• Yuguo Chen, Professor

  Qliu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang, Doctor

CONTACT

0086-0531-82165674; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 20, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-02

Locations

CN (1)