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

Not Applicable

Withdrawn

• Conditions: Acute Coronary Syndrome; Telemetry; Chest Pain; Health Care Resource Utilization
• Interventions: Other: No Telemetry Monitoring; Device: Telemetry Monitoring

• Registration Number: NCT02330328
• Lead Sponsor: Carilion Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-01
• Study Start: 2015-04
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Telemetry Monitoring	No Telemetry Monitoring	The participants in this arm will be admitted to a bed without telemetry monitoring
Telemetry	Telemetry Monitoring	The participants in this arm will be admitted to a bed with telemetry monitoring

Primary Outcome Measures

Name	Time	Method
Ventricular fibrillation	Baseline
Death	up to 1 year after enrollment
Sustained (> 30 seconds) or symptomatic ventricular tachycardia	up to 60 sec

Secondary Outcome Measures

Name	Time	Method
Negative Stress Test	Baseline, 30 days and 1 year after enrollment
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
Cardiac catheterization result	Baseline, 30 days and 1 year after enrollment