Genetic PolymorphismNCT00603148
The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications
An observational study of Genetic Polymorphism, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies, the data obtained from this study will be used to prospectively stratify patients in terms of bleeding verses thrombotic risk to design… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Genetic Polymorphism
- How many people
- 475 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing procedures in a hybrid interventional cardiology/cardiac surgery suite
Who may be able to join
- Patients will be recruited to the study who are to undergo elective hybrid procedures [percutaneous coronary intervention (PCI) followed by minimally invasive coronary artery bypass graft (CABG) surgery or valve surgery].
- Both male and females will be enrolled in this study.
- The age of the population is 18-70 years old.
- No one ethnic group or gender will be targeted or excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications in Patients Undergoing Invasive Procedures in the Hybrid Cardiac Catheterization/Cardiac Surgery Suite
This study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies, the data obtained from this study will be used to prospectively stratify patients in terms of bleeding verses thrombotic risk to design studies to optimize anticoagulation and anti-platelet therapies in the hybrid setting.
Read the detailed description
The aim of this study is to test the association of DNA polymorphisms linked to the level of αβ1 integrin expression on platelets with clinical outcome in terms of bleeding or thrombotic complications. The association of polymorphisms in other genes such as GPVI, PAR-1, and COX-2, as well as PLA ½ status, will also be examined and considered in the context of other factors such as medications including IIb/IIIa inhibitors, anticoagulants, type of procedure, obesity smoking status, etc.
Lower levels of platelet surface expression of the α2β1 integrin are associated with an increased risk of bleeding complications following hybrid procedures, especially when the low level of integrin expression is associated with other risk factors that may exacerbate bleeding such as vigorous anti-coagulation, aggressive anti-platelet therapy and other genetic risk factors that contribute to a hemorrhagic phenotype. Conversely, higher level expression of the α2β1 integrin is likely associated with a greater tendency to thrombotic complication that is again modified by other coexisting risk factors.
- Conditions
- Genetic Polymorphism
- Keywords
- Genetic Polymorphism, Integrin alpha2beta1, Phenotype
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startSep 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PolymorphismStudies 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
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Samuel A. Santoro, Vanderbilt University
- Investigators
- Samuel A. Santoro, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603148
- Sponsor's protocol ID
- 060433
- Status last verified
- Dec 2013
- First submitted
- 17 Oct 2007
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications in Patients Undergoing Invasive Procedures in the Hybrid Cardiac Catheterization/Cardiac Surgery Suite
- ClinicalTrials.gov ID
- NCT00603148
- Acronym / sponsor ID
- 060433
- Conditions
- Genetic Polymorphism
- Keywords
- Genetic Polymorphism, Integrin alpha2beta1, Phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Jan 2008 (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 study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies, the data obtained from this study will be used to prospectively stratify patients in terms of bleeding verses thrombotic risk to design studies to optimize anticoagulation and anti-platelet therapies in the hybrid setting.
Detailed description
The aim of this study is to test the association of DNA polymorphisms linked to the level of αβ1 integrin expression on platelets with clinical outcome in terms of bleeding or thrombotic complications. The association of polymorphisms in other genes such as GPVI, PAR-1, and COX-2, as well as PLA ½ status, will also be examined and considered in the context of other factors such as medications including IIb/IIIa inhibitors, anticoagulants, type of procedure, obesity smoking status, etc.
Lower levels of platelet surface expression of the α2β1 integrin are associated with an increased risk of bleeding complications following hybrid procedures, especially when the low level of integrin expression is associated with other risk factors that may exacerbate bleeding such as vigorous anti-coagulation, aggressive anti-platelet therapy and other genetic risk factors that contribute to a hemorrhagic phenotype. Conversely, higher level expression of the α2β1 integrin is likely associated with a greater tendency to thrombotic complication that is again modified by other coexisting risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing procedures in a hybrid interventional cardiology/cardiac surgery suite
Key inclusion criteria (4 listed)
- Patients will be recruited to the study who are to undergo elective hybrid procedures [percutaneous coronary intervention (PCI) followed by minimally invasive coronary artery bypass graft (CABG) surgery or valve surgery].
- Both male and females will be enrolled in this study.
- The age of the population is 18-70 years old.
- No one ethnic group or gender will be targeted or excluded.
Key exclusion criteria (0 listed)
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
genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures
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 17 Dec 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.
Samuel A. Santoro, MD, PhD principal investigator
Vanderbilt University
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 Genetic Polymorphism, run by Vanderbilt University 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 4 inclusion and 0 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 17 Dec 2013. 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?
genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures. 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 17 Dec 2013.