Chest PainNCT02330328
Telemetry for Chest Pain of Low Risk for Acute Coronary Syndrome Pts
A study testing No Telemetry Monitoring and Telemetry Monitoring in people with Chest Pain and Telemetry, run by Carilion Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Chest Pain, Telemetry, Acute Coronary Syndrome
- What is being tested?
- No Telemetry Monitoring and Telemetry Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant must be admitted for chest pain and evaluation of acute coronary syndrome
Who cannot join
- 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
About this study
Official title: Evaluation of the Utility of Telemetry in Patients Admitted for Chest Pain Who Are at Low Risk for Acute Coronary Syndrome
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.
Read the 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.
- Being tested
- No Telemetry Monitoring, Telemetry Monitoring
- Keywords
- Chest Pain, Telemetry
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Telemetry MonitoringOther
Telemetry MonitoringDevice
| Study group | Role | What they receive |
|---|---|---|
| No Telemetry Monitoring | Experimental | The participants in this arm will be admitted to a bed without telemetry monitoring Receives: Other: No Telemetry Monitoring |
| Telemetry | Active comparator | The participants in this arm will be admitted to a bed with telemetry monitoring Receives: Device: Telemetry Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained (> 30 seconds) or symptomatic ventricular tachycardia
Measured: up to 60 sec
Ventricular fibrillation
Measured: Baseline
Death
Measured: up to 1 year after enrollment
Secondary outcomes (5)
Non-ST Segment Elevation Myocardial Infarction (NSTEMI)
Measured: Baseline, 30 days and 1 year after enrollment
ST Segment Elevation Myocardial Infarction (STEMI)
Measured: Baseline, 30 days and 1 year from enrollment
Positive Stress Test
Measured: Baseline, 30 days and 1 year after enrollment
Negative Stress Test
Measured: Baseline, 30 days and 1 year after enrollment
Cardiac catheterization result
Measured: Baseline, 30 days and 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2017
- Study completionJul 2017
Why it stopped: Collaborator withdrew closing the study prematurely with no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- John Perkins, MD, Principal investigator, Carlion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330328
- Sponsor's protocol ID
- NA_00091964
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2014
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 7484840Hollander 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.
PubMed 14707944Durairaj 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.
PubMed 11152858O'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 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.
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.
PubMed 24268896Hermann 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.
PubMed 19231025Collin 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.
PubMed 20825795Than 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.
PubMed 22578923Henriques-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.
PubMed 19487558
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of Telemetry in Patients Admitted for Chest Pain Who Are at Low Risk for Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02330328
- Acronym / sponsor ID
- NA_00091964
- Keywords
- Chest Pain, Telemetry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Collaborator withdrew closing the study prematurely with no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- 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
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Telemetry Monitoring | Experimental | Other: No Telemetry MonitoringThe participants in this arm will be admitted to a bed without telemetry monitoring |
| Telemetry | Active comparator | Device: Telemetry MonitoringThe participants in this arm will be admitted to a bed with telemetry monitoring |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participant must be admitted for chest pain and evaluation of acute coronary syndrome
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Telemetry Monitoring | Other | No Telemetry Monitoring |
| Telemetry Monitoring | Device | Telemetry |
Primary outcome
Sustained (> 30 seconds) or symptomatic ventricular tachycardia
Time frame: up to 60 sec
Ventricular fibrillation
Time frame: Baseline
Death
Time frame: up to 1 year after enrollment
5 secondary outcomes
Non-ST Segment Elevation Myocardial Infarction (NSTEMI)
Time frame: Baseline, 30 days and 1 year after enrollment
ST Segment Elevation Myocardial Infarction (STEMI)
Time frame: Baseline, 30 days and 1 year from enrollment
Positive Stress Test
Time frame: Baseline, 30 days and 1 year after enrollment
Negative Stress Test
Time frame: Baseline, 30 days and 1 year after enrollment
Cardiac catheterization result
Time frame: Baseline, 30 days and 1 year after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 7484840Estrada 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.
- Background: PubMed 14707944Hollander 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.
- Background: PubMed 11152858Durairaj 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.
- BackgroundO'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.
- BackgroundPerkins 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: PubMed 24268896Perkins 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.
- Background: PubMed 19231025Hermann 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.
- Background: PubMed 20825795Collin 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.
- Background: PubMed 22578923Than 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.
- Background: PubMed 19487558Henriques-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.
- Telemetry bed usage for patient with low risk chest pain.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Perkins, MD principal investigator
Carlion Clinic
Questions about this trial
What is this clinical trial studying?
A study testing No Telemetry Monitoring and Telemetry Monitoring in people with Chest Pain and Telemetry, run by Carilion Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained (> 30 seconds) or symptomatic ventricular tachycardia (time frame: up to 60 sec). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330328, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.