MCG for Risk Stratifications of Patients With Chest Pain

Recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Magnetocardiography

• Registration Number: NCT06316011
• Lead Sponsor: Qilu Hospital of Shandong University

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）.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-18
• Study Start: 2024-03-20
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3620

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training and testing cohort	Magnetocardiography	-
External validation cohort	Magnetocardiography	-

Primary Outcome Measures

Name	Time	Method
Efficacy of MCG for the detection and risk stratification in high-risk patients with chest pain	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	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.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China