Telemetry for Chest Pain of Low Risk for Acute Coronary Syndrome Pts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chest Pain, Telemetry, Acute Coronary Syndrome, Health Care Resource Utilization

Intervention / Treatment
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* Other: No Telemetry Monitoring
* Device: Telemetry Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be admitted for chest pain and evaluation of acute coronary syndrome Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No Telemetry Monitoring<br>The participants in this arm will be admitted to a bed without telemetry monitoring | Other: No Telemetry Monitoring<br> <br> |
| Active Comparator: Telemetry<br>The participants in this arm will be admitted to a bed with telemetry monitoring | Device: Telemetry Monitoring<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained (> 30 seconds) or symptomatic ventricular tachycardia |  | up to 60 sec | 
| Ventricular fibrillation |  | Baseline | 
| Death |  | up to 1 year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Positive Stress Test |  | Baseline, 30 days and 1 year after enrollment | 
| Negative Stress Test |  | Baseline, 30 days and 1 year after enrollment | 
| Cardiac catheterization result |  | Baseline, 30 days and 1 year after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest Pain, Telemetry