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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Withdrawn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
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring Chest Pain, Telemetry

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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