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

NCT02330328 | Withdrawn DMC

• 1 other identifier: NA_00091964
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chest Pain; Telemetry; Acute Coronary Syndrome; Health Care Resource Utilization

Keywords

Chest Pain; Telemetry

Outcome Measures

Primary Outcomes (3)

• Sustained (> 30 seconds) or symptomatic ventricular tachycardia

  up to 60 sec

• Ventricular fibrillation

  Baseline

• Death

  up to 1 year after enrollment

Secondary Outcomes (5)

• 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

Study Arms (2)

No Telemetry Monitoring

EXPERIMENTAL

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

Other: No Telemetry Monitoring

Telemetry

ACTIVE COMPARATOR

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

Device: Telemetry Monitoring

Interventions

No Telemetry Monitoring OTHER

No Telemetry Monitoring

Telemetry Monitoring DEVICE

Telemetry

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be admitted for chest pain and evaluation of acute coronary syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Johns Hopkins University: collaborator
• University of Maryland, College Park: collaborator
• Virginia Commonwealth University: collaborator
• Medstar Health Research Institute: collaborator
• Virginia Tech Carilion School of Medicine and Research Institute: collaborator

Related Publications (10)

• 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.

  PMID: 7484840 BACKGROUND

• 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.

  PMID: 14707944 BACKGROUND

• 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.

  PMID: 11152858 BACKGROUND

• 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.

  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.

  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.

  PMID: 24268896 BACKGROUND

• 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.

  PMID: 19231025 BACKGROUND

• 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.

  PMID: 20825795 BACKGROUND

• 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.

  PMID: 22578923 BACKGROUND

• 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.

  PMID: 19487558 BACKGROUND

Related Links

• Telemetry bed usage for patient with low risk chest pain.

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• John Perkins, MD

  Carlion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 1, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 13, 2020

Record last verified: 2020-01