Coronary Artery DiseaseAIRNCT00379418
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients
An observational study of Coronary Artery Disease, run by Emory University at 2 sites in United States.
Trial summary
AIR STUDY TITLE: Anti-Ischemic effects of Abciximab(Reopro) PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Abciximab
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to Dec 2009
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with coronary artery disease undergoing left heart catheterization
Who may be able to join
- Have either:
- clinical history of anginal symptoms or positive stress test or
- in stent restenosis
- Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure
- For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose
- negative pregnancy test
- are able to give informed consent
Who cannot join
- Coronary intervention within four weeks prior to enrollment.
- Treatment with abciximab antagonist within four weeks.
- treatment with thrombolytic therapy within 48 hours
- MI within 2 months.
- recent infections
- general anesthesia within 3 months.
- renal failure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta VA Medical Center
Atlanta, Georgia, 30033
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)
AIR STUDY
TITLE: Anti-Ischemic effects of Abciximab(Reopro)
Read more
PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).
INTERVENTION: Heparin vs. heparin + abciximab during PCI
PURPOSE: Measure the effects of abciximab on special healing blood stem cells (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on microvascular blood flow.
PATIENT ASSESSMENT:
- 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.
- Measurement of blood flow in selected suitable patients
- 10 minute questionnaire before discharge and on visit on day 28.
- Conditions
- Coronary Artery Disease
- Being tested
- Abciximab
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbciximabDrug
Also called Reopro
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJan 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kreton Mavromatis, MD, FACC, Emory University
- Investigators
- Arshed A Quyyumi, M.D., Principal investigator, EUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379418
- Sponsor's protocol ID
- IRB00021864
- Acronym
- AIR
- Status last verified
- Sep 2013
- First submitted
- 19 Sep 2006
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)
- ClinicalTrials.gov ID
- NCT00379418
- Acronym / sponsor ID
- AIR / IRB00021864
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Sep 2006 (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.
AIR STUDY
TITLE: Anti-Ischemic effects of Abciximab(Reopro)
PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).
INTERVENTION: Heparin vs. heparin + abciximab during PCI
PURPOSE: Measure the effects of abciximab on special healing blood stem cells (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on microvascular blood flow.
PATIENT ASSESSMENT:
- 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.
- Measurement of blood flow in selected suitable patients
- 10 minute questionnaire before discharge and on visit on day 28.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with coronary artery disease undergoing left heart catheterization
Key inclusion criteria (7 listed)
- Have either:
- Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure
- For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose
- negative pregnancy test
- are able to give informed consent
Key exclusion criteria (7 listed)
- Coronary intervention within four weeks prior to enrollment.
- Treatment with abciximab antagonist within four weeks.
- treatment with thrombolytic therapy within 48 hours
- MI within 2 months.
- recent infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbciximabAlso: Reopro | Drug | – |
Primary outcome
Not reported in the source record.
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 12 Sep 2013.
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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.
Arshed A Quyyumi, M.D. principal investigator
EUH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Emory University at 2 sites 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 7 inclusion and 7 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 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 12 Sep 2013.