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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Winthrop University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT00952055
First received: July 31, 2009
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


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 ]

Estimated Enrollment: 180
Study Start Date: July 2003
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients diagnosed with acute coronary syndrome (ACS)

  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
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: Joshua DeLeon, M.D. Principal Investigator, Winthrop-University Hospital
ClinicalTrials.gov Identifier: NCT00952055     History of Changes
Other Study ID Numbers: 03028
Study First Received: July 31, 2009
Last Updated: May 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
neopterin
macrophage
inflammation

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

ClinicalTrials.gov processed this record on May 16, 2013