Clinical trial NCT00952055: Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin
Official title: Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Coronary Syndrome
Keywords: neopterin
macrophage
inflammation
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 152
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute cornary syndrome

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine if serum neopterin is a useful marker in risk stratifying patients with acute coronary syndromes as it relates to vascular endothelial dysfunction.
timeFrame: 8 year study - 2011 anticipated study completion
Secondary outcomes:
measure: Evaluate whether serum neopterin is a useful marker in a similar manner as LPGD-S.
timeFrame: 5 years
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop-University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Joshua DeLeon, MD
role: PRINCIPAL_INVESTIGATOR
References: