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

NCT ID: NCT02330328

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-07-31

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.

Conditions

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Chest Pain Telemetry Acute Coronary Syndrome Health Care Resource Utilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Telemetry Monitoring

The participants in this arm will be admitted to a bed without telemetry monitoring

Group Type EXPERIMENTAL

No Telemetry Monitoring

Intervention Type OTHER

Telemetry

The participants in this arm will be admitted to a bed with telemetry monitoring

Group Type ACTIVE_COMPARATOR

Telemetry Monitoring

Intervention Type DEVICE

Interventions

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No Telemetry Monitoring

Intervention Type OTHER

Telemetry Monitoring

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role collaborator

Virginia Tech Carilion School of Medicine and Research Institute

OTHER

Sponsor Role collaborator

Carilion Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Perkins, MD

Role: PRINCIPAL_INVESTIGATOR

Carlion Clinic

References

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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.

Reference Type BACKGROUND
PMID: 7484840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14707944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11152858 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 24268896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19231025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20825795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22578923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19487558 (View on PubMed)

Related Links

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http://www.aaem.org/UserFiles/file/4.11.11BODApprvdTelemetryWebPosting.pdf

Telemetry bed usage for patient with low risk chest pain.

Other Identifiers

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NA_00091964

Identifier Type: -

Identifier Source: org_study_id

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