STEMINCT01569646
Monocytosis and Culprit Vessel in STEMI Patients
An observational study of STEMI, run by Northwell Health at 1 site in United States.
Trial summary
Increased white blood cell count at the onset of an acute ST elevation myocardial infarction has been shown to be associated of increased incidence of heart failure and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: STEMI patients,
Who may be able to join
- STEMI
Who cannot join
- Patients on antibiotics and steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Significance of Monocytosis and Culprit Vessel in Patients With Acute ST Elevation Myocardial Infarction
Increased white blood cell count at the onset of an acute ST elevation myocardial infarction has been shown to be associated of increased incidence of heart failure and mortality. Now monocytes which are a subset of white blood cells may have a prognostic value for patients presenting with acute ST segment elevation myocardial infarction. A monocyte count of greater than 800/mm3 following acute myocardial infarction has been shown to be associated with increased incidence of left ventricular dysfunction. The investigators study would retrospectively collect data on patients with ST elevation myocardial infarction, looking for an association between high monocyte count and the culprit vessel causing the myocardial infarction. The investigators would also investigate whether monocytosis would be a marker of poor prognosis.
- Conditions
- STEMI
- Keywords
- monocytes, culprit vessels
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between monocyte count and culprit vessel
Measured: 1 day
Secondary outcomes (1)
clinical outcomes of troponin and monocyte in stemi patients
Measured: 0 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duccio Baldari, MD, FACC, Principal investigator, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569646
- Sponsor's protocol ID
- 08-021
- Status last verified
- Mar 2012
- First submitted
- 2 Jun 2010
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Monocytosis and Culprit Vessel in Patients With Acute ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01569646
- Acronym / sponsor ID
- 08-021
- Conditions
- STEMI
- Keywords
- monocytes, culprit vessels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2008
- First posted
- 3 Apr 2012 (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.
Increased white blood cell count at the onset of an acute ST elevation myocardial infarction has been shown to be associated of increased incidence of heart failure and mortality. Now monocytes which are a subset of white blood cells may have a prognostic value for patients presenting with acute ST segment elevation myocardial infarction. A monocyte count of greater than 800/mm3 following acute myocardial infarction has been shown to be associated with increased incidence of left ventricular dysfunction. The investigators study would retrospectively collect data on patients with ST elevation myocardial infarction, looking for an association between high monocyte count and the culprit vessel causing the myocardial infarction. The investigators would also investigate whether monocytosis would be a marker of poor prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- STEMI patients,
Key inclusion criteria (1 listed)
- STEMI
Key exclusion criteria (1 listed)
- Patients on antibiotics and steroids
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
Association between monocyte count and culprit vessel
Time frame: 1 day
1 secondary outcome
clinical outcomes of troponin and monocyte in stemi patients
Time frame: 0 - 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
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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.
Duccio Baldari, MD, FACC principal investigator
Staten Island 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 STEMI, run by Northwell Health 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 1 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: finished, as of the sponsor's last update on 3 Apr 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association between monocyte count and culprit vessel (time frame: 1 day). 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 3 Apr 2012.