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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00952055
• Other study ID #: 03028
• Status: Terminated
• Phase: N/A
• First received: July 31, 2009
• Last updated: January 15, 2015
• Start date: July 2003
• Est. completion date: August 2011

Study information

• Verified date: January 2015
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Winthrop-University Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate whether serum neopterin is a useful marker in a similar manner as LPGD-S.		5 years	No