跳至主要内容
临床试验/NCT05825911
NCT05825911招募中不适用

Evaluation of Diagnostic Accuracy of MCG Scan in Suspected Coronary Artery Disease

AMCG2 个研究点 分布在 1 个国家目标入组 908 人开始时间: 2024年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
AMCG
入组人数
908
试验地点
2
主要终点
Sensitivity and specificity of MCG scan

研究概览

简要总结

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

详细描述

This is multicenter, prospective, observational trial to evaluate the diagnostic accuracy of magnetocardiography(MCG) scan in detecting significant coronary artery disease(CAD) compared to the reference standard coronary arteriography(CAG). Chest pain patients scheduled for CAG will be offered to enroll in this clinical trial and provide informed consent to undergo with a rest/stress MCG scan prior to CAG. This MCG scan with a new 96 channel superconducting quantum interference device(SQUID) system is radiation-free, contactless and takes less than ten minutes to complete. Multiple studies have shown that the diagnostic accuracy of stress MCG scan is quite high in identifying patients with symptomatic CAD. Results will be interpreted and compared to the results of cardiac SPECT stress test, if available, and CAG. Participants will be followed up to 30 days via phone call or chart review. 30 day major adverse cardiac event(MACE) will be recorded and correlated with initial MCG scan results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Sensitivity and specificity of MCG scan

时间窗: 1 day

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.

次要结局

  • Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan(1 day)

研究者

发起方
AMCG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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