Telemetry for Chest Pain of Low Risk for Acute Coronary Syndrome Pts
Primary Purpose
Chest Pain, Telemetry, Acute Coronary Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No Telemetry Monitoring
Telemetry Monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Chest Pain focused on measuring Chest Pain, Telemetry
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No Telemetry Monitoring
Telemetry
Arm Description
The participants in this arm will be admitted to a bed without telemetry monitoring
The participants in this arm will be admitted to a bed with telemetry monitoring
Outcomes
Primary Outcome Measures
Sustained (> 30 seconds) or symptomatic ventricular tachycardia
Ventricular fibrillation
Death
Secondary Outcome Measures
Non-ST Segment Elevation Myocardial Infarction (NSTEMI)
ST Segment Elevation Myocardial Infarction (STEMI)
Positive Stress Test
Negative Stress Test
Cardiac catheterization result
Full Information
NCT ID
NCT02330328
First Posted
December 31, 2014
Last Updated
January 8, 2020
Sponsor
Carilion Clinic
Collaborators
Johns Hopkins University, University of Maryland, College Park, Virginia Commonwealth University, Medstar Health Research Institute, Virginia Tech Carilion School of Medicine and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02330328
Brief Title
Telemetry for Chest Pain of Low Risk for Acute Coronary Syndrome Pts
Official Title
Evaluation of the Utility of Telemetry in Patients Admitted for Chest Pain Who Are at Low Risk for Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Collaborator withdrew closing the study prematurely with no participants enrolled
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic
Collaborators
Johns Hopkins University, University of Maryland, College Park, Virginia Commonwealth University, Medstar Health Research Institute, Virginia Tech Carilion School of Medicine and Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Telemetry, Acute Coronary Syndrome, Health Care Resource Utilization
Keywords
Chest Pain, Telemetry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Telemetry Monitoring
Arm Type
Experimental
Arm Description
The participants in this arm will be admitted to a bed without telemetry monitoring
Arm Title
Telemetry
Arm Type
Active Comparator
Arm Description
The participants in this arm will be admitted to a bed with telemetry monitoring
Intervention Type
Other
Intervention Name(s)
No Telemetry Monitoring
Intervention Type
Device
Intervention Name(s)
Telemetry Monitoring
Primary Outcome Measure Information:
Title
Sustained (> 30 seconds) or symptomatic ventricular tachycardia
Time Frame
up to 60 sec
Title
Ventricular fibrillation
Time Frame
Baseline
Title
Death
Time Frame
up to 1 year after enrollment
Secondary Outcome Measure Information:
Title
Non-ST Segment Elevation Myocardial Infarction (NSTEMI)
Time Frame
Baseline, 30 days and 1 year after enrollment
Title
ST Segment Elevation Myocardial Infarction (STEMI)
Time Frame
Baseline, 30 days and 1 year from enrollment
Title
Positive Stress Test
Time Frame
Baseline, 30 days and 1 year after enrollment
Title
Negative Stress Test
Time Frame
Baseline, 30 days and 1 year after enrollment
Title
Cardiac catheterization result
Time Frame
Baseline, 30 days and 1 year after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Perkins, MD
Organizational Affiliation
Carlion Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
7484840
Citation
Estrada CA, Rosman HS, Prasad NK, Battilana G, Alexander M, Held AC, Young MJ. Role of telemetry monitoring in the non-intensive care unit. Am J Cardiol. 1995 Nov 1;76(12):960-5. doi: 10.1016/s0002-9149(99)80270-7.
Results Reference
background
PubMed Identifier
14707944
Citation
Hollander JE, Sites FD, Pollack CV Jr, Shofer FS. Lack of utility of telemetry monitoring for identification of cardiac death and life-threatening ventricular dysrhythmias in low-risk patients with chest pain. Ann Emerg Med. 2004 Jan;43(1):71-6. doi: 10.1016/s0196-0644(03)00719-4.
Results Reference
background
PubMed Identifier
11152858
Citation
Durairaj L, Reilly B, Das K, Smith C, Acob C, Husain S, Saquib M, Ganschow P, Evans A, McNutt R. Emergency department admissions to inpatient cardiac telemetry beds: a prospective cohort study of risk stratification and outcomes. Am J Med. 2001 Jan;110(1):7-11. doi: 10.1016/s0002-9343(00)00640-9.
Results Reference
background
Citation
O'Neill DR. Low-risk classified chest pain patients: Do they need cardiac monitoring in the emergency department and can they be cared for in non-monitored beds? Australian Emerg Nur J 2007; 10:58-63.
Results Reference
background
Citation
Perkins JC, Voore N, Patel J, et al: Assessment of an Emergency Department Chest Pain Patient Cohort at Low Risk for Significant Adverse Events During Admission for Acute Coronary Syndrome. SAEM Mid-Atlantic Regional Meeting, 02/2014, Philadephia, PA.
Results Reference
background
PubMed Identifier
24268896
Citation
Perkins J, McCurdy MT, Vilke GM, Al-Marshad AA. Telemetry bed usage for patients with low-risk chest pain: review of the literature for the clinician. J Emerg Med. 2014 Feb;46(2):273-7. doi: 10.1016/j.jemermed.2013.08.098. Epub 2013 Nov 22.
Results Reference
background
PubMed Identifier
19231025
Citation
Hermann LK, Weingart SD, Duvall WL, Henzlova MJ. The limited utility of routine cardiac stress testing in emergency department chest pain patients younger than 40 years. Ann Emerg Med. 2009 Jul;54(1):12-6. doi: 10.1016/j.annemergmed.2009.01.006. Epub 2009 Feb 23.
Results Reference
background
PubMed Identifier
20825795
Citation
Collin MJ, Weisenthal B, Walsh KM, McCusker CM, Shofer FS, Hollander JE. Young patients with chest pain: 1-year outcomes. Am J Emerg Med. 2011 Mar;29(3):265-70. doi: 10.1016/j.ajem.2009.09.031. Epub 2010 Mar 25.
Results Reference
background
PubMed Identifier
22578923
Citation
Than M, Cullen L, Aldous S, Parsonage WA, Reid CM, Greenslade J, Flaws D, Hammett CJ, Beam DM, Ardagh MW, Troughton R, Brown AF, George P, Florkowski CM, Kline JA, Peacock WF, Maisel AS, Lim SH, Lamanna A, Richards AM. 2-Hour accelerated diagnostic protocol to assess patients with chest pain symptoms using contemporary troponins as the only biomarker: the ADAPT trial. J Am Coll Cardiol. 2012 Jun 5;59(23):2091-8. doi: 10.1016/j.jacc.2012.02.035. Epub 2012 May 9.
Results Reference
background
PubMed Identifier
19487558
Citation
Henriques-Forsythe MN, Ivonye CC, Jamched U, Kamuguisha LK, Olejeme KA, Onwuanyi AE. Is telemetry overused? Is it as helpful as thought? Cleve Clin J Med. 2009 Jun;76(6):368-72. doi: 10.3949/ccjm.76a.07260.
Results Reference
background
Links:
URL
http://www.aaem.org/UserFiles/file/4.11.11BODApprvdTelemetryWebPosting.pdf
Description
Telemetry bed usage for patient with low risk chest pain.
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Telemetry for Chest Pain of Low Risk for Acute Coronary Syndrome Pts
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