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

September 30, 2008 updated by: Redmond Fire Department Medic One

Randomized Trial of Prehospital Troponin Assessment Using the i-STAT Blood Analyzer

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.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • -Mobile Units in King County-, Washington, United States, 98052
        • Redmond Fire Department Medic One Units

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen and treated by Redmond Fire Department Medic One.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Study Group
Troponin measured prior to hospital arrival
Control Group
Patients transported to hospital without troponin measurements enroute

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease door-to-reperfusion time for patients with non-STEMI's by measuring troponin levels prior to hospital arrival
Time Frame: 3-4 years
3-4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: James P Jordan, BS, MS, MICP, Redmond Fire Department Medic One

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2008

Last Update Submitted That Met QC Criteria

September 30, 2008

Last Verified

September 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

3
Subscribe