跳至主要内容
临床试验/NCT02330328
NCT02330328撤回不适用

Evaluation of the Utility of Telemetry in Patients Admitted for Chest Pain Who Are at Low Risk for Acute Coronary Syndrome

Carilion Clinic0 个研究点开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Ventricular fibrillation

研究概览

简要总结

This is a randomized controlled, multi-center, non-blinded non-inferiority study examining the utility of telemetry monitoring in patients admitted who are low risk for acute coronary syndrome. Each of the six sites will prospectively enroll 250 patients in each arm of the study randomized to either a med-surg bed (no telemetry) or a telemetry bed during their admission. Research study coordinators will enroll patients and then follow them throughout their hospital course and record primary and secondary end point events.

详细描述

This is a randomized controlled, multi-center, non-blinded non-inferiority study examining the utility of telemetry monitoring in patients admitted who are low risk for acute coronary syndrome. Each of the six sites will prospectively enroll 250 patients in each arm of the study randomized to either a med-surg bed (no telemetry) or a telemetry bed during their admission. Research study coordinators will enroll patients and then follow them throughout their hospital course and record primary and secondary end point events.

The research coordinators will collect information on the following items for data collection: age, gender, smoking history, history of hypertension, history of diabetes mellitus, history of hypercholesterolemia, and history of family member with early heart disease or myocardial infarction, and body mass index. Research coordinators will document if the patient had any of the following events during their hospital course: death, myocardial infarction (MI), upgrade to a higher level of care, dysrhythmia, results of any stress testing or cardiac catheterization. In addition patients will be contacted at 30 days and 365 days to inquire about MI, needing for percutaneous coronary intervention (PCI), or revascularization (CABG).

Based on previous studies, we hypothesize that patients aged 18-49 years who are at low risk for Acute Coronary Syndrome (ACS) are unlikely to benefit from continuous heart monitoring while admitted to the hospital for chest pain. We suspect that the rate of significant events may approach zero in this group of participants. This study aim is to show that a bed without remote monitoring- telemetry- is adequate when these low risk participants with chest pain are hospitalized.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participant must be admitted for chest pain and evaluation of acute coronary syndrome

排除标准

  • History of coronary artery disease, previous myocardial infarction, or any percutaneous intervention either documented in the medical report or verbal report by patient
  • Have an initial troponin serum value above the threshold for that hospital's normal limit
  • Have used cocaine in the previous 14 days (patient report)
  • Have an abnormal ECG as determined by attending emergency physician
  • Unable to consent for the study due to language barrier or mental incapacity
  • Admitting attending physician does not agree with randomization of the patient into either study arm
  • Pregnancy

结局指标

主要结局

Ventricular fibrillation

时间窗: Baseline

Death

时间窗: up to 1 year after enrollment

Sustained (> 30 seconds) or symptomatic ventricular tachycardia

时间窗: up to 60 sec

次要结局

  • Positive Stress Test(Baseline, 30 days and 1 year after enrollment)
  • Non-ST Segment Elevation Myocardial Infarction (NSTEMI)(Baseline, 30 days and 1 year after enrollment)
  • ST Segment Elevation Myocardial Infarction (STEMI)(Baseline, 30 days and 1 year from enrollment)
  • Negative Stress Test(Baseline, 30 days and 1 year after enrollment)
  • Cardiac catheterization result(Baseline, 30 days and 1 year after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

相似试验