Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206830
Status:
COMPLETED
Last Update Posted:
2015-07-27
First Post:
2005-09-13
Brief Title:
SHORTness of Breath In the Emergency Department SHORTIE
Sponsor:
Abbott RDx Cardiometabolic
Organization:
Abbott RDx Cardiometabolic
Study Overview
Official Title:
SHORTness of Breath In the Emergency Department SHORTIE
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SHORTIE is a two-phase study to determine the impact of the Triage Profiler SOB Shortness Of Breath Panel on patient management outcome and cost
Detailed Description:
Patients presenting to the ED with a primary complaint of shortness of breath will a have blood sample collected at enrollment and tested using the Triage Profiler SOB Panel measuring creatine kinase MB CK-MB myoglobin troponin I B-type natriuretic peptide BNP D-dimer The test is used as an aid in the diagnosis of myocardial infarction MI an aid in the diagnosis and assessment of severity of heart failure HF and an aid in the assessment and evaluation of disseminated intravascular coagulation including pulmonary embolism PE Phase I is an observational study and results of the Triage Profiler SOB panel will be blinded to all attending physicians and health care workers In Phase II patients will be assigned to either the experimental arm or the control arm of the study In the experimental arm the Triage Profiler SOB Panel results will be available to the treating physician and can be incorporated into the decision making process In the control arm treating physicians and staff will be blinded to the Triage Profiler SOB Panel results Time to appropriate treatment length of ED stay patient outcome and hospital costs will be assessed in all patients and used to determine the impact of Triage Profiler SOB Panel on these parameters Furthermore the diagnostic accuracy of the Triage Profiler SOB Panel will be calculated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None