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

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
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.

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

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.

Clinical Trials on Acute Coronary Syndrome

3
Subscribe