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Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.

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ClinicalTrials.gov Identifier: NCT00276432
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : January 28, 2010
Sponsor:
Collaborators:
Abbott
University of Cincinnati
William Beaumont Hospitals
Information provided by:
Mayo Clinic

Study Description
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Brief Summary:
The primary outcome in this study will be time to discharge for low-risk patients and therapeutic turnaround time for patients with NSTEMI or unstable angina.

Condition or disease Intervention/treatment Phase
Unstable Angina Non-ST-Elevation Myocardial Infarction Device: iSTAT point of care analyzer Phase 4

Detailed Description:
Phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. Assess the reduction in time taken to dispostion or discharge patients. Assess the ability of POC testing to satisfy guidelines for a 30 minute turn around time of results. Assess and differences in clinical decision-making for other diagnostic procedures including nuclear imaging, echo, and stress treadmill, disposition from the ED, time to catherterization lab, PCI, and CafBG based on the cardiac troponinn results from the bedside analyzer and the central lab instrument.Assess the difference for in-hospital and 30 day post hospital discharge cardiac events including all-cause and cardiac-specific deaths, CHF, cardiomyopathy, and atrial and ventricular arrhythmia, beween the bedside analyzer and the central lab instrument. Assess the differences in hospital care costs for the hospitalization period, and assess direct medical and indirect productivity costs in the 30 day post hospital discharge period to patients who are diagnosed, using the bedside cTnl test and the central lab cTn tests, and subsequently treated as per the guidelines.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Diagnosis and Treatment of Acute Coronary Syndrome in the Emergency Department- The Impact of Rapid Bedside cTnl on Outcome.
Study Start Date : November 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Time to discharge for low-risk patients
  2. Therapeutic turnaround time for patients with NSTEMI or unstable angina

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Patient must be 21 years old or older with chest pain or other symptoms that lead to drawing cardiac biomarkers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276432


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Abbott
University of Cincinnati
William Beaumont Hospitals
Investigators
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Principal Investigator: Wyatt W. Decker, M.D. Mayo Clinic
More Information
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ClinicalTrials.gov Identifier: NCT00276432    
Other Study ID Numbers: 637-05
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms