Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.
Primary Purpose
Unstable Angina, Non-ST-Elevation Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
iSTAT point of care analyzer
Sponsored by
About this trial
This is an interventional diagnostic trial for Unstable Angina
Eligibility Criteria
Patient must be 21 years old or older with chest pain or other symptoms that lead to drawing cardiac biomarkers.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Time to discharge for low-risk patients
Therapeutic turnaround time for patients with NSTEMI or unstable angina
Secondary Outcome Measures
Full Information
NCT ID
NCT00276432
First Posted
January 11, 2006
Last Updated
January 27, 2010
Sponsor
Mayo Clinic
Collaborators
Abbott, University of Cincinnati, William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00276432
Brief Title
Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.
Official Title
Diagnosis and Treatment of Acute Coronary Syndrome in the Emergency Department- The Impact of Rapid Bedside cTnl on Outcome.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Abbott, University of Cincinnati, William Beaumont Hospitals
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Angina, Non-ST-Elevation Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
iSTAT point of care analyzer
Primary Outcome Measure Information:
Title
Time to discharge for low-risk patients
Title
Therapeutic turnaround time for patients with NSTEMI or unstable angina
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient must be 21 years old or older with chest pain or other symptoms that lead to drawing cardiac biomarkers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wyatt W. Decker, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.
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