Acute Coronary SyndromeNCT00952055
Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin
An observational study of Acute Coronary Syndrome, run by Winthrop University Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute cornary syndrome
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- malignancy,
- phenylketonuria,
- immune mediated liver disease, and
- patients taking immunomodulating therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop-University Hospital
Mineola, New York, 11501
About this study
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..
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- neopterin, macrophage, inflammation
- Medical subject headings
- Acute Coronary Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with acute coronary syndrome (ACS) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if serum neopterin is a useful marker in risk stratifying patients with acute coronary syndromes as it relates to vascular endothelial dysfunction.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2003
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: 1\) A delay in obtaining immunoassays to measure serum neopterin 2)altered relevance of the expected experimental results to clinical practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara George, Winthrop University Hospital
- Investigators
- Joshua DeLeon, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952055
- Sponsor's protocol ID
- 03028
- Status last verified
- Jan 2015
- First submitted
- 31 Jul 2009
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standard Treatment of Acute Coronary Syndromes on Macrophage Activity as Measured by Serum Neopterin
- ClinicalTrials.gov ID
- NCT00952055
- Acronym / sponsor ID
- 03028
- Conditions
- Acute Coronary Syndrome
- Keywords
- neopterin, macrophage, inflammation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 1\) A delay in obtaining immunoassays to measure serum neopterin 2)altered relevance of the expected experimental results to clinical practice
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with acute coronary syndrome (ACS) | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute cornary syndrome
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- History of medical conditions known to alter neopterin concentrations in blood. The exclusion criteria includes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Evaluate whether serum neopterin is a useful marker in a similar manner as LPGD-S.
Time frame: 5 years
Results and safety
The study was stopped early (reason given: 1\) A delay in obtaining immunoassays to measure serum neopterin 2)altered relevance of the expected experimental results to clinical practice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua DeLeon, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 1\) A delay in obtaining immunoassays to measure serum neopterin 2)altered relevance of the expected experimental results to clinical practice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.