Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease

NCT05825911 | Recruiting

• 1 other identifier: AMCG-CT01
• Study Type: observational
• Target: 908
• Locations: 1 country
• Sites: 2

Brief Summary

This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.

Conditions

Coronary Artery Disease

Keywords

Magnetocardiography scan; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of MCG scan

  Compare the diagnostic accuracy of stress MCG scan in detecting significant CAD compared to the current standard reference coronary angiogram(CAG) with statistical analysis including sensitivity, specificity.

  1 day

Secondary Outcomes (1)

• Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan

  1 day

Other Outcomes (3)

• Major adverse cardiac event after 30 days of CAG

  1 month

• Comparison of MCG scan with cardiac SPECT test

  1 day

• Comparison of sensitivity and specificity between stress MCG scan and stress ECG test

  1 day

Interventions

Rest/Stress MCG scan DIAGNOSTIC_TEST

All patients enrolled and receiving standard screening tests for CAD will undergo rest/stress MCG scan before CAG.

Rest MCG scan DIAGNOSTIC_TEST

This is an normal adult population with age-, and sex-matched control group. All participants enrolled will undergo rest MCG scan.

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. MAIN STUDY: This is an adult population at varying risk for CAD who will present at multicenter for cardiovascular screening with CAG. 2. SUB-STUDY: This is an normal adult population with age-, and sex-matched control group.

You may qualify if:

• Over 19 years of age at the time of enrollment
• Patient presenting for CAG
• Consents to having an MCG scan study

You may not qualify if:

• Patients unable to fit into MCG scan device
• Patients with implanted cardiac pacemakers/defibrillators
• Atrial fibrillation with rapid ventricular response
• Patients with other sustained or incessant arrhythmias
• Presence clinical suspicious of any acute coronary syndrome

Sponsors & Collaborators

• AMCG: lead

Study Sites (2)

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, 03312, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hoseong Lee Deputy general manager

  AMCG

  STUDY DIRECTOR

Central Study Contacts

Hoseong Lee Deputy general manager

CONTACT

+82-02-598-8001; lhs@amcg.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: June 24, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)