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| ID | Type | Description | Link |
|---|---|---|---|
| HFHS: ED CARDS Registry | Registry Identifier | HFHS: ED~Cards Collaborative |
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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.
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.
Inclusion/Exclusion Criteria
Inclusion Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OBSERVATIONAL REGISTRY | Individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OBSERVATIONAL REGISTRY | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Study Objective | The study objective is to collect blood and plasma specimens for the assessment of ACS Biologic Assessments in patients presenting to the Emergency Department with symptoms consistent with ACS according to Henry Ford Medical Group current system guidelines. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| ACS Marker Evaluation | To evaluate early exclusion and/or inclusion of ACS with high sensitive cTn and newer cTn assays or other novel markers . | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Candidates for enrollment will be individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED).
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Richard M Nowak, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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).