Status:
UNKNOWN
Finding Acute Coronary Syndromes (ACS) With Serial Troponin Testing for Rapid Assessment of Cardiac Ischemic Symptoms
Lead Sponsor:
Nanosphere, Inc.
Conditions:
Acute Coronary Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
Study Objectives The following items will be prospectively assessed. Primary Endpoints 1. For patients presenting with clinical suspicion of Acute Coronary Syndromes (ACS), high sensitivity-cardiac...
Detailed Description
This study will evaluate the ability of a high sensitivity cardiac troponin I (hs-cTnI) assay to detect and to rule-out high-risk ischemic cardiac injury in emergency room patients experiencing signs ...
Eligibility Criteria
Inclusion
- The subject must be at least 18 years of age or older.
- The subject must present to the Emergency Department with symptoms consistent with acute coronary syndromes (e.g., chest discomfort/pain, squeezing/fullness in the chest, pain radiating to left or both arms, jaw pain, pain in back/neck/stomach, shortness of breath, cold sweat, nausea/vomiting, lightheadedness).
- The subject must present to the Emergency Department within six (6) hours of the onset of the most recent symptoms that prompted the subject to seek medical attention in the Emergency Department.
- The subject agrees to abide by the protocol, including all telephone follow-up.
Exclusion
- The subject is in acute distress and requires immediate life-saving intervention.
- The subject has experienced CPR, defibrillation, or cardioversion within 24 hours of presentation to the Emergency Department.
- The subject cannot give consent or understand the informed consent form.
- The subject has a terminal illness (e.g. metastatic cancer) and is not expected to survive 6 months.
- Patient has trauma related ACS symptoms (i.e. penetrating wounds, crush injury).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00880802
Start Date
December 1 2008
End Date
March 1 2011
Last Update
January 12 2010
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Davis
Davis, California, United States, 95817
2
University of California San Diego
San Diego, California, United States, 92103
3
Veterans Affairs Medical Center San Diego
San Diego, California, United States, 92161
4
Stanford University
Stanford, California, United States, 94305