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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02330328
Enrollment
0
Registered
2015-01-01
Start date
2015-04-30
Completion date
2017-07-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Chest Pain, Telemetry

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.

Interventions

OTHERNo Telemetry Monitoring

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sustained (> 30 seconds) or symptomatic ventricular tachycardiaup to 60 sec
Ventricular fibrillationBaseline
Deathup to 1 year after enrollment

Secondary

MeasureTime frame
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 TestBaseline, 30 days and 1 year after enrollment
Negative Stress TestBaseline, 30 days and 1 year after enrollment
Cardiac catheterization resultBaseline, 30 days and 1 year after enrollment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026