An interventional study of No Telemetry Monitoring and Telemetry Monitoring in Chest Pain, Telemetry and Acute Coronary Syndrome, sponsored by Carilion Clinic. Withdrawn. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Carilion Clinic · Not applicable, Interventional, and Treatment
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.
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
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Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.
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Exclusion Criteria:
The participants in this arm will be admitted to a bed without telemetry monitoring
Other: No Telemetry Monitoring
The participants in this arm will be admitted to a bed with telemetry monitoring
Device: Telemetry Monitoring
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
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
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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