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Randomized Trial of Prehospital Tropin Levels in Acute Coronary Syndrome (ACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Redmond Fire Department Medic One.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Medic One Foundation
Information provided by:
Redmond Fire Department Medic One
ClinicalTrials.gov Identifier:
NCT00764205
First received: September 30, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

This study randomizes patients seen by Redmond Medic One into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ECG's (i.e.non-STEMI). The control group is treated normally and delivered to the receiving hospital. The study group is treated normally as well, however troponin measurements are made using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the receiving physician. Door-to-reperfusion time is monitored for both groups.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Randomized Trial of Prehospital Troponin Assessment Using the i-STAT Blood Analyzer

Resource links provided by NLM:

MedlinePlus related topics: Fires
U.S. FDA Resources

Further study details as provided by Redmond Fire Department Medic One:

Primary Outcome Measures:
  • Decrease door-to-reperfusion time for patients with non-STEMI's by measuring troponin levels prior to hospital arrival [ Time Frame: 3-4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: November 2006
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
Troponin measured prior to hospital arrival
Control Group
Patients transported to hospital without troponin measurements enroute

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seen and treated by Redmond Fire Department Medic One.

Criteria

Inclusion Criteria:

  • Over years of age
  • ACS without ST-segment elevation
  • Patient being transported to one of two participating hospitals

Exclusion Criteria:

  • Less then 18 years of age.
  • Post cardiac arrest.
  • ACS with ST-segment elevation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764205

Locations
United States, Washington
Redmond Fire Department Medic One Units
-Mobile Units in King County-, Washington, United States, 98052
Sponsors and Collaborators
Redmond Fire Department Medic One
Medic One Foundation
Investigators
Principal Investigator: James P Jordan, BS, MS, MICP Redmond Fire Department Medic One
  More Information

No publications provided

Responsible Party: James P. Jordan BS, MS, MICP, Redmond Fire Deparment Medic One
ClinicalTrials.gov Identifier: NCT00764205     History of Changes
Other Study ID Numbers: 20070224
Study First Received: September 30, 2008
Last Updated: September 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Redmond Fire Department Medic One:
ACS
non STEMI
ECG troponin
iSTAT
Acute coronary syndrome without ST-segment elevation

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013