A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 335
- 试验地点
- 4
- 主要终点
- Relationship between pre-procedural MCG and the peri-procedural angiography-based measures
研究概览
简要总结
PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute myocardial infarction
- •Ability for participant to comply with study requirements
- •Patient consented before the planned, clinically indicated cath-lab procedure begins to allow sufficient time for study related activities
- •Written informed consent
排除标准
- •Present STEMI
- •Pregnant or breastfeeding
- •Having an active atrial fibrillation episode as seen on most current 12-lead ECG
- •Active thoracic metal implant
- •Poor access to follow-up
研究组 & 干预措施
ACS
Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS). Patients are further classified as having low, medium, and high risk for ACS.
干预措施: Sponsor MCG device (CardiAQ) (Device)
结局指标
主要结局
Relationship between pre-procedural MCG and the peri-procedural angiography-based measures
时间窗: Data taken within 24 hours of each other
Utilize linear regression and logistic regression to determine whether a set of a priori MCG-based biomarkers can prospectively predict the objective clinical assessment of ACS, while statistically adjusting for covariates.
次要结局
- Sponsor MCG device safety(30 days)