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

This study has been terminated.
(1) A delay in obtaining immunoassays to measure serum neopterin 2)altered relevance of the expected experimental results to clinical practice)
Sponsor:
Information provided by (Responsible Party):
Barbara George, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00952055
First received: July 31, 2009
Last updated: January 15, 2015
Last verified: January 2015
  Purpose

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..


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate whether serum neopterin is a useful marker in a similar manner as LPGD-S. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: July 2003
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients diagnosed with acute coronary syndrome (ACS)

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute cornary syndrome

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952055

Locations
United States, New York
Winthrop-University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Joshua DeLeon, MD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Barbara George, Research Coordinator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT00952055     History of Changes
Other Study ID Numbers: 03028
Study First Received: July 31, 2009
Last Updated: January 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
neopterin
macrophage
inflammation

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on April 27, 2015