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临床试验/NCT04739267
NCT04739267已完成不适用

The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study

Genetesis Inc.1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2021年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
390
试验地点
1
主要终点
To prove that MCG can accurately diagnose myocardial ischemia

研究概览

简要总结

Approximately 16.5 million people suffer from coronary artery disease (CAD) and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath, commonly suggestive of acute coronary syndrome (ACS). To clinically assess ACS risk in these patients, there are typically 2-6 hours of emergency room evaluation, followed by 6-42 hours of an observation period prior to discharge. The clinical pathway includes: 1) 1-3 ECG's; 2) serial troponins (1 and 3 hours vs 1 and 6 hours); and 3) other pertinent diagnostic information, including but not limited to echocardiography, stress testing and/or CT Angiography. Patients who are evaluated, have presented with a low risk for ACS, and maintain negative diagnostic results can potentially be discharged within 6 hours. However, 20%-40% of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing, such as stress testing. The purpose of ACCMED is to measure the efficacy of Magnetocardiography (MCG) as a diagnostic tool to rule-in/rule-out myocardial ischemia in patients with suspicion of an acute coronary syndrome who have a HEART Score > 2 and to allow safe and timely disposition of the patient to an appropriate level of care.

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

入选标准

  • ≥ 18 years of age at the time of enrollment.
  • Patient presenting acutely with signs and symptoms suggestive of ACS.
  • Informed Consent Form signed by subject or LAR.
  • HEART Score of >
  • Patient consented within 4 hours of the beginning of the clinical assessment (exclusive of any screening examination) for suspected ACS by an appropriately credentialed clinician.

排除标准

  • < 18 years of age.
  • Unable to fit into device.
  • Non-ambulatory patients.
  • Positive response on MCG metal checklist.
  • Deemed hemodynamically unstable by treating physician, regardless of cause.
  • Unable to lie supine for up to 5 minutes.
  • Poor candidate for follow-up (e.g., no access to phone).
  • Repeat participants.

结局指标

主要结局

To prove that MCG can accurately diagnose myocardial ischemia

时间窗: 1 year

Demonstrate the following: 1. MCG has a clinically acceptable sensitivity and specificity for the detection of myocardial ischemia. This will be compared to the Gold Standard of index revascularization, ≥70% stenosis in any coronary artery as determined by invasive coronary angiography, or 30-day MACE. 2. MCG is non-inferior to noninvasive downstream testing (DS) for the identification of patients with myocardial ischemia. 3. MCG is non-inferior to noninvasive downstream testing (DS) for appropriate referral of patients to invasive coronary angiography with decision to refer the patient to the coronary catheterization laboratory as the Gold Standard.

次要结局

  • To demonstrate that MCG provides value to the traditional HEART score for risk stratification of patients with suspected ACS.(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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