- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952055
Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin
January 15, 2015 updated by: Barbara George, Winthrop University Hospital
This is a prospective observational study focused on monitoring the effects of various treatment options for acute coronary syndrome (ACS) patients by measuring serum neopterin levels.
Serum neopterin is a marker for measuring macrophage activation.
Prior studies have illustrated that there are elevated serum neopterin levels in ACS.
Patients enrolled are those with ACS.
Blood samples are drawn at presentation, and at 72 hours after admission, or at office visits and at 72 hours later.
Neopterin levels are measured via a commercially available assay..
Study Overview
Status
Terminated
Conditions
Detailed Description
The study is a prospective observational study focused on monitoring the effects of various treatment options for acute coronary syndrome (ACS) patients by measuring serum neopterin levels.
Serum neopterin is a marker for measuring macrophage activation.
Prior studies have illustrated that there are elevated serum neopterin levels in ACS.
The investigators' study focused on comparing different treatment arms with regard to their neopterin levels and correlating neopterin levels to the Thrombolysis in Myocardial Infarction (TIMI) risk score.
Patients enrolled are those with ACS.
Blood samples are drawn at presentation, and at 72 hours after admission, or at office visits and at 72 hours later.
Neopterin levels are measured via a commercially available assay.
Study Type
Observational
Enrollment (Actual)
152
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Mineola, New York, United States, 11501
- Winthrop-University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Acute cornary syndrome
Description
Inclusion Criteria:
- Chest pain and either ST segment elevation or depression > 0.1 mV in at least 2 contiguous electrocardiographic leads as well as elevation in troponin levels.
Exclusion Criteria:
History of medical conditions known to alter neopterin concentrations in blood. The exclusion criteria includes:
- renal failure,
- history of HIV,
- transplant patients,
- active infections,
- history of autoimmune disease,
- malignancy,
- phenylketonuria,
- immune mediated liver disease, and
- patients taking immunomodulating therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients diagnosed with acute coronary syndrome (ACS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if serum neopterin is a useful marker in risk stratifying patients with acute coronary syndromes as it relates to vascular endothelial dysfunction.
Time Frame: 8 year study - 2011 anticipated study completion
|
8 year study - 2011 anticipated study completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate whether serum neopterin is a useful marker in a similar manner as LPGD-S.
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joshua DeLeon, MD, Winthrop University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
July 31, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 4, 2009
Study Record Updates
Last Update Posted (Estimate)
January 16, 2015
Last Update Submitted That Met QC Criteria
January 15, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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