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

This study has been completed.
Sponsor:
Collaborators:
Abbott
University of Cincinnati
William Beaumont Hospitals
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00276432
First received: January 11, 2006
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Unstable Angina
Non-ST-Elevation Myocardial Infarction
Device: iSTAT point of care analyzer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Diagnosis and Treatment of Acute Coronary Syndrome in the Emergency Department- The Impact of Rapid Bedside cTnl on Outcome.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Time to discharge for low-risk patients
  • Therapeutic turnaround time for patients with NSTEMI or unstable angina

Enrollment: 350
Study Start Date: November 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276432

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Abbott
University of Cincinnati
William Beaumont Hospitals
Investigators
Principal Investigator: Wyatt W. Decker, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00276432     History of Changes
Other Study ID Numbers: 637-05
Study First Received: January 11, 2006
Last Updated: January 27, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina, Unstable
Infarction
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014