Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | April 2015 |
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.
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.
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 and/or 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 6-8.5 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 subject's 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 subject's 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 subject's case report form.
- Approximately 6-8.5 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 6-8.5 mL/tube type
will occur at t1 = 30 (+/- 10 minutes) after t0, t2=1 (+/-15 minutes) hour after t0, t4
= 3 (+/- 15 minutes) hours after t0 (if the patient is still in the ED/hospital).
- 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.
Inclusion/Exclusion 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 and/or 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
the Principal Investigator or trained study coordinator (SC). Candidates for enrollment will
be individuals presenting with signs and/or 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 6-8.5 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 subject's 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 subject's 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 subject's case report form.
- Approximately 6-8.5 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 6-8.5 mL/tube type
will occur at t1 = 30 (+/- 10 minutes) after t0, t2=1 (+/-15 minutes) hour after t0, t4
= 3 (+/- 15 minutes) hours after t0 (if the patient is still in the ED/hospital).
- 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.
Inclusion/Exclusion 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 and/or 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
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 and/or 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
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