Randomized Trial of Prehospital Tropin Levels in Acute Co... | NCT00764205

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

NCT00764205

Sponsor

Redmond Fire Department Medic One

Status

Unknown status

Last Update Posted

Oct 1, 2008Estimated

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Nov 2009Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2008

Last Update Posted Date

Oct 1, 2008Estimated

Name	Class
Medic One Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Troponin measured prior to hospital arrival
Control Group		Patients transported to hospital without troponin measurements enroute

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients seen and treated by Redmond Fire Department Medic One.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James P Jordan, BS, MS, MICP	Redmond Fire Department Medic One	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Redmond Fire Department Medic One Units		-Mobile Units in King County-	Washington	98052	United States

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D000072658	Non-ST Elevated Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided