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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Redmond Fire Department Medic One Medic One Foundation, Seattle Washington
Information provided by:	Redmond Fire Department Medic One
ClinicalTrials.gov Identifier:	NCT00764205

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

MedlinePlus related topics: Fires

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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, Seattle Washington

Investigators

Principal Investigator:

James P Jordan, BS, MS, MICP

Redmond Fire Department Medic One

More Information

Responsible Party:	Redmond Fire Deparment Medic One ( James P. Jordan BS, MS, MICP )
Study ID Numbers:	20070224
Study First Received:	September 30, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00764205
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

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009