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

Acute Coronary Syndrome Clinical Trial

Official title:

Evaluation of the Utility of Telemetry in Patients Admitted for Chest Pain Who Are at Low Risk for Acute Coronary Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02330328
• Other study ID #: NA_00091964
• Status: Withdrawn
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 2017

Study information

• Verified date: January 2020
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• No Telemetry Monitoring

Device:
• Telemetry Monitoring

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Carilion Clinic	Johns Hopkins University, Medstar Health Research Institute, University of Maryland, College Park, Virginia Commonwealth University, Virginia Tech Carilion School of Medicine and Research Institute

References & Publications (10)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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.

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. Review. — View 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained (> 30 seconds) or symptomatic ventricular tachycardia		up to 60 sec
Primary	Ventricular fibrillation		Baseline
Primary	Death		up to 1 year after enrollment
Secondary	Non-ST Segment Elevation Myocardial Infarction (NSTEMI)		Baseline, 30 days and 1 year after enrollment
Secondary	ST Segment Elevation Myocardial Infarction (STEMI)		Baseline, 30 days and 1 year from enrollment
Secondary	Positive Stress Test		Baseline, 30 days and 1 year after enrollment
Secondary	Negative Stress Test		Baseline, 30 days and 1 year after enrollment
Secondary	Cardiac catheterization result		Baseline, 30 days and 1 year after enrollment

External Links

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