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Triage Profiler S.O.B. Panel

Phase 2

Acute Myocardial Infarction | Unknown | Cardiovascular |Abbott Laboratories|Last Updated: Jul 27, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment306

FDA Designations

No designations recorded

Clinical trial landscape

Triage Profiler S.O.B. Panel · 1 trial · 3 indications

Phase 2 1
NCT00206830SHORTness of Breath In the Emergency Department (SHORTIE)Acute Myocardial Infarction
COMPLETED306 Analytics
PHASE2COMPLETED
SHORTness of Breath In the Emergency Department (SHORTIE)
Acute Myocardial InfarctionUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to specific treatment for final diagnosis
Length of stay in the emergency department (ED)
ED and total hospital costs

Secondary Endpoints

Outcome at 30 days (Phase I and II) and 90 days (Phase II)
Diagnostic accuracy of the Triage® Profiler S.O.B. panel for acute myocardial infarction (AMI), heart failure (HF) and pulmonary embolism (PE) in patients presenting with S.O.B.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Control-Blinded from ResultsNO_INTERVENTION -
Access to ResultsEXPERIMENTAL -

Interventions

NameTypeDescription
Triage Profiler S.O.B. PanelDEVICE -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Age 18 and older. * Visit to the ED is due to a primary complaint of shortness of breath alone or shortness of breath with associated chest pain, cough or edema. Exclusion Criteria: * Blood sample cannot be collected before treatment is initiated, specifically CPR or treatme...

Countries:United States
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Frequently asked questions about Triage Profiler S.O.B. Panel

What is the Triage Profiler S.O.B. Panel used for?

The Triage Profiler S.O.B. Panel is an investigational diagnostic tool being studied for use in Acute Myocardial Infarction, as well as Heart Failure and Pulmonary Embolism. It is intended to aid in the evaluation of patients presenting with shortness of breath in the emergency department setting.

Who makes the Triage Profiler S.O.B. Panel?

Abbott Laboratories (NYSE: ABT) is the developer of the Triage Profiler S.O.B. Panel. The company is conducting clinical research on this diagnostic panel for cardiovascular conditions.

What phase is the Triage Profiler S.O.B. Panel in?

The Triage Profiler S.O.B. Panel is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is the Triage Profiler S.O.B. Panel in?

The Triage Profiler S.O.B. Panel was studied in the SHORTness of Breath In the Emergency Department (SHORTIE) trial, registered as NCT00206830. This Phase 2, randomized, double-blind, no-treatment-controlled study enrolled 306 participants in the United States and has been completed.

Is the Triage Profiler S.O.B. Panel FDA approved?

The Triage Profiler S.O.B. Panel is not FDA approved. It is an investigational diagnostic currently in Phase 2 clinical development. The completed trial, NCT00206830, evaluated its use in patients with acute myocardial infarction, heart failure, and pulmonary embolism.