Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415948
Status:
COMPLETED
Last Update Posted:
2009-12-18
First Post:
2006-12-21
Brief Title:
Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome MIDAS - Sample Procurement
Sponsor:
Abbott RDx Cardiometabolic
Organization:
Abbott RDx Cardiometabolic
Study Overview
Official Title:
Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome MIDAS - Sample Procurement
Status:
COMPLETED
Status Verified Date:
2009-12
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:
The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS Acute Coronary Syndrome
Detailed Description:
This is a prospective multi-center observational and sample procurement study of adult subjects presenting to an Emergency Department ED in whom ACS is in the differential diagnosis Subjects must present to one of the participating EDs within 6 hours or less from the time of symptom onset and must have experienced at least 30 minutes of chest discomfort Those ED patients with possible ACS who meet the inclusionexclusion criteria will be approached for study enrollment by trained research personnel
The patients diagnostic work-up and treatment will continue per the standards of the treating institution As indicated by their clinical presentation all subjects in the study will have objective cardiac testing for evidence of coronary artery disease CAD during or in close proximity to the index ED visit or hospital admission For this study objective cardiac testing will consist of one of the following tests exercise treadmill coronary angiography myocardial stress imaging stress magnetic resonance imaging MRI sestamibi scan or dobutamine echocardiogram Cardiac events and procedures such as angioplasty-stenting and coronary artery bypass surgery CABG will be recorded during the index ED visit hospitalization and post-hospital follow-up period Subjects will have a 30-day and 6-month follow-up contact by phone to collect this information on cardiac events procedures and survival
The patients diagnostic work-up and treatment will continue per the standards of the treating institution As indicated by their clinical presentation all subjects in the study will have objective cardiac testing for evidence of coronary artery disease CAD during or in close proximity to the index ED visit or hospital admission For this study objective cardiac testing will consist of one of the following tests exercise treadmill coronary angiography myocardial stress imaging stress magnetic resonance imaging MRI sestamibi scan or dobutamine echocardiogram Cardiac events and procedures such as angioplasty-stenting and coronary artery bypass surgery CABG will be recorded during the index ED visit hospitalization and post-hospital follow-up period Subjects will have a 30-day and 6-month follow-up contact by phone to collect this information on cardiac events procedures and survival
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