Ignite Creation Date:
2024-05-06 @ 2:11 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01984853
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2013-10-30
Brief Title:
Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
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:
EDCards
Brief Summary:
This is an OBSERVATIONAL Specimen procurement and data collections trial for acute coronary syndrome that will be conducted in the Emergency Department at Henry Ford Hospital
The standard protocol for evaluating patients in the Emergency Department for possible acute myocardial infarction includes the measurement of cardiac troponin over 3 hours Subjects presenting to the ED with chest discomfort or ischemic symptoms will be eligible for blood draw protocol The study is blinded to treating physicians and does not change current standard of care After informed consent patients will have blood samples drawn at 0 30 minutes 1 hour and 3 hours
Serum from the samples will be stored in a -80 research freezer to be evaluated at a later time as new cardiac markers for acute coronary syndrome are developed
The standard protocol for evaluating patients in the Emergency Department for possible acute myocardial infarction includes the measurement of cardiac troponin over 3 hours Subjects presenting to the ED with chest discomfort or ischemic symptoms will be eligible for blood draw protocol The study is blinded to treating physicians and does not change current standard of care After informed consent patients will have blood samples drawn at 0 30 minutes 1 hour and 3 hours
Serum from the samples will be stored in a -80 research freezer to be evaluated at a later time as new cardiac markers for acute coronary syndrome are developed
Detailed Description:
Subjects considered for enrollment in this study will be identified and approached by either the Principal Investigator or trained study coordinator SC Candidates for enrollment will be individuals presenting with signs andor symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department ED
This specimen collection study is a prospective serial draw plasma collection study designed to collect specimens for use in existing or future clinical studies Specimen collection is expected to take approximately 30-36 months Specimens will be collected from subjects that are being evaluated for Acute Coronary Syndrome ACS
Other than sample collection no special procedures or medications are required by the study
The study aims to enroll approximately 250-500 individuals evaluated for possible ACS in the ED
Specimens will be obtained from the subject at the following time points
t0 Baseline ECG ECG time 60 minutes t1 within 30 - 10 minutes minutes after t0 t2 1 - 15 minutes hours after t0 t3 3 -15 minutes hours after t0
Each sample will consist of approximately 6-85 ml of blood in each of two anticoagulant tube types SST and K2EDTA plasma Four serial specimens will be collected within 3 hours of presentation to the ED for observation of ACS
The Investigator or designee will obtain the subjects written informed consent prior to collecting the specimen
Each subject will be given a unique study number An enrollment log will be used to document the enrollment of individuals by study number This study number will be used to identify the individual throughout the study
Each subject will have a medical history reviewed and documented as well as significant cardiac medical history documented in the subjects case report form in addition to demographic information including age gender race ethnicity and medication history
Each subject will have a baseline ECG obtained in the ED vital signs and routine laboratory results These will be documented in the subjects case report form
Approximately 6-85 ml of blood will be collected in each of two anticoagulant tube types SST and K2EDTA plasma The first blood collection in the ED is designated as t0 ED ECG time 60 minutes Additional blood draws of approximately 6-85 mLtube type will occur at t1 30 - 10 minutes after t0 t21 -15 minutes hour after t0 t4 3 - 15 minutes hours after t0 if the patient is still in the EDhospital
For each draw a minimum volume after processing of approximately 2 mL of plasma should be obtained The specimens will be processed aliquoted and retained in a -70 secured freezer
InclusionExclusion Criteria
Inclusion Criteria
Patient greater than 21 years of age
Experiencing symptoms of possible ACS
Willing and able to comply with all aspect of the protocol
Exclusion Criteria
Acute distress andor requires immediate life-saving intervention
CPR external defibrillation or cardioversion within 24 hours of presentation
Unable to provide or understand the informed consent
STEMI leading to immediate reperfusion
Transferred from another facility
Trauma related injuries
Pregnancy or breast feeding
This specimen collection study is a prospective serial draw plasma collection study designed to collect specimens for use in existing or future clinical studies Specimen collection is expected to take approximately 30-36 months Specimens will be collected from subjects that are being evaluated for Acute Coronary Syndrome ACS
Other than sample collection no special procedures or medications are required by the study
The study aims to enroll approximately 250-500 individuals evaluated for possible ACS in the ED
Specimens will be obtained from the subject at the following time points
t0 Baseline ECG ECG time 60 minutes t1 within 30 - 10 minutes minutes after t0 t2 1 - 15 minutes hours after t0 t3 3 -15 minutes hours after t0
Each sample will consist of approximately 6-85 ml of blood in each of two anticoagulant tube types SST and K2EDTA plasma Four serial specimens will be collected within 3 hours of presentation to the ED for observation of ACS
The Investigator or designee will obtain the subjects written informed consent prior to collecting the specimen
Each subject will be given a unique study number An enrollment log will be used to document the enrollment of individuals by study number This study number will be used to identify the individual throughout the study
Each subject will have a medical history reviewed and documented as well as significant cardiac medical history documented in the subjects case report form in addition to demographic information including age gender race ethnicity and medication history
Each subject will have a baseline ECG obtained in the ED vital signs and routine laboratory results These will be documented in the subjects case report form
Approximately 6-85 ml of blood will be collected in each of two anticoagulant tube types SST and K2EDTA plasma The first blood collection in the ED is designated as t0 ED ECG time 60 minutes Additional blood draws of approximately 6-85 mLtube type will occur at t1 30 - 10 minutes after t0 t21 -15 minutes hour after t0 t4 3 - 15 minutes hours after t0 if the patient is still in the EDhospital
For each draw a minimum volume after processing of approximately 2 mL of plasma should be obtained The specimens will be processed aliquoted and retained in a -70 secured freezer
InclusionExclusion Criteria
Inclusion Criteria
Patient greater than 21 years of age
Experiencing symptoms of possible ACS
Willing and able to comply with all aspect of the protocol
Exclusion Criteria
Acute distress andor requires immediate life-saving intervention
CPR external defibrillation or cardioversion within 24 hours of presentation
Unable to provide or understand the informed consent
STEMI leading to immediate reperfusion
Transferred from another facility
Trauma related injuries
Pregnancy or breast feeding
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HFHS ED CARDS Registry | REGISTRY | HFHS EDCards Collaborative | None |