Multi-Markers In the Diagnosis of Acute Coronary Syndrome



Status:Archived
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:March 2010
End Date:March 2011

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Multi-Markers In the Diagnosis of Acute Coronary Syndrome - Sample Procurement Cohort 3


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 patient's 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.


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 inclusion/exclusion criteria will be
approached for study enrollment by trained research personnel.

The patient's 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.


We found this trial at
6
sites
Stony Brook, New York 11794
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Stony Brook, NY
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Brooklyn, NY
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Cleveland, Ohio 44195
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Cleveland, OH
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