Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01134913
Status:
COMPLETED
Last Update Posted:
2012-08-31
First Post:
2010-05-29
Brief Title:
Multi-Markers In the Diagnosis of Acute Coronary Syndrome
Sponsor:
Abbott RDx Cardiometabolic
Organization:
Abbott RDx Cardiometabolic
Study Overview
Official Title:
Multi-Markers In the Diagnosis of Acute Coronary Syndrome - Sample Procurement Cohort 3
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Midas 3
Brief Summary:
This is a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected ACS Acute Coronary Syndrome
Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn at different time points during their emergency department visit In addition data will be collected about the patients health history hospital procedures and final diagnosis The enrolling center will also contact the patients at 30-days 3 months and 6 months to inquire about their condition and survival
Blood samples collected in this study will be sent to the sponsor organization for long-term storage and analysis in the future for novel blood markers as they become available No genetic testing will be conducted on these samples
Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn at different time points during their emergency department visit In addition data will be collected about the patients health history hospital procedures and final diagnosis The enrolling center will also contact the patients at 30-days 3 months and 6 months to inquire about their condition and survival
Blood samples collected in this study will be sent to the sponsor organization for long-term storage and analysis in the future for novel blood markers as they become available No genetic testing will be conducted on these samples
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 5 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 it is anticipated that all patients in this study will have an electrocardiogram ECG upon admission to the ED and if the patient is found not to have an ST-elevation myocardial infarction STEMI objective cardiac testing will be conducted for evidence of MI The Principal Investigator at each site will evaluate the results of the objective cardiac tests combined with biomarker evidence of myocardial necrosis to determine whether or not a patient enrolled at their site has a final diagnosis of ACS
Cardiac events and procedure 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 3 month and 6 month follow-up contact by phone or medical chart review to collect this information on cardiac events procedures and survival
Blood samples collected at several time points during the index ED visit will be used for future testing of novel blood markers as they become available
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 it is anticipated that all patients in this study will have an electrocardiogram ECG upon admission to the ED and if the patient is found not to have an ST-elevation myocardial infarction STEMI objective cardiac testing will be conducted for evidence of MI The Principal Investigator at each site will evaluate the results of the objective cardiac tests combined with biomarker evidence of myocardial necrosis to determine whether or not a patient enrolled at their site has a final diagnosis of ACS
Cardiac events and procedure 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 3 month and 6 month follow-up contact by phone or medical chart review to collect this information on cardiac events procedures and survival
Blood samples collected at several time points during the index ED visit will be used for future testing of novel blood markers as they become available
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