NCT00952055

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..

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

8.1 years

First QC Date

July 31, 2009

Last Update Submit

January 15, 2015

Conditions

Acute Coronary Syndrome

Keywords

neopterinmacrophageinflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluate whether serum neopterin is a useful marker in a similar manner as LPGD-S.

    5 years

Study Arms (1)

Patients diagnosed with acute coronary syndrome (ACS)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute cornary syndrome

You may qualify if:

  • 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.

You may not qualify if:

  • renal failure,
  • history of HIV,
  • transplant patients,
  • active infections,
  • history of autoimmune disease,
  • malignancy,
  • phenylketonuria,
  • immune mediated liver disease, and
  • patients taking immunomodulating therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop-University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Acute Coronary SyndromeInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joshua DeLeon, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 4, 2009

Study Start

July 1, 2003

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

US(1)