Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin

Terminated

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT00952055
• Lead Sponsor: Winthrop University Hospital

Brief Summary

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..

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 Timeline

• Study Start: 2003-07
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine if serum neopterin is a useful marker in risk stratifying patients with acute coronary syndromes as it relates to vascular endothelial dysfunction.	8 year study - 2011 anticipated study completion

Secondary Outcome Measures

Name	Time	Method
Evaluate whether serum neopterin is a useful marker in a similar manner as LPGD-S.	5 years

Trial Locations

Locations (1)

Winthrop-University Hospital; 🇺🇸 Mineola, New York, United States