Coronary Artery BypassNCT00481806
Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery
An observational study of Coronary Artery Bypass and Thrombosis, run by University of Arizona at 1 site in United States.
Trial summary
Heart bypass surgery, also known as coronary artery bypass graft (CABG) surgery, creates a detour around the blocked part of a heart artery to restore blood supply to the heart muscle. The saphenous vein, located along the inside of the leg, is commonly used to create the bypass in a CABG surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Bypass, Thrombosis
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients between the the age of 18-90 years belonging to all races will be enrolled in the study
Who may be able to join
- Scheduled for CABG surgery at University of Arizona University Medical Center (UMC)
- For females, willing to use a reliable form of birth control for the duration of the study
Who cannot join
- Non-dermatologic allergy to intravenous (IV) radiographic contrast
- Creatinine levels greater than 2.0 mg/dL
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona College of Medicine
Tucson, Arizona, 85724
Robert S. Poston, MD
About this study
Official title: Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
Heart bypass surgery, also known as coronary artery bypass graft (CABG) surgery, creates a detour around the blocked part of a heart artery to restore blood supply to the heart muscle. The saphenous vein, located along the inside of the leg, is commonly used to create the bypass in a CABG surgery. An abnormal increase in the blood clotting protein thrombin may cause the saphenous vein graft to close up and eventually fail. This study will evaluate the relationship between thrombin levels and saphenous vein graft failures in people undergoing a CABG procedure.
Read the detailed description
The saphenous vein, which runs from the ankle to the groin along the inside of the leg, is commonly used as a graft for people undergoing a CABG surgery. The vein is removed from the leg and reattached to the heart to create a detour around the blocked part of a coronary artery. Following this procedure, many people are prescribed aspirin as a way to increase the chance that the graft procedure will be successful. However, saphenous vein graft failure may still occur in some people, indicating a need to understand why this happens and who might be at risk for graft failure. Thrombin, a protein involved in the blood clotting process, is somehow related to aspirin resistance, abnormalities in blood flow, and cell disruption within the saphenous vein, all factors thought to increase the risk of graft failure. The purpose of this study is to evaluate the likelihood that a burst in thrombin contributes to graft failure in people who have recently undergone a CABG procedure using the saphenous vein.
This study will enroll individuals undergoing CABG surgery at the University of Maryland. Prior to and immediately following surgery, an incision will be made in the skin and the time required for the blood to form a clot will be determined. During surgery, participants' blood vessels will be examined using imaging and cell analysis techniques. Blood collection will occur before surgery, immediately after surgery, and on Days 1, 3, and 30 following surgery. A portion of blood will be frozen for future analysis. An x-ray of the saphenous vein will be performed on Day 5 and again at a follow-up visit 6 to 12 months following surgery. Kidney function will be measured at both of these visits prior to the x-ray procedure. At the second visit, health and mental status questionnaires will be completed.
- Conditions
- Coronary Artery Bypass, Thrombosis
- Keywords
- Virchow's Triad, Thrombin, Graft Failure
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation
Measured: Measured at 5 years
Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG
Measured: Measured at 5 years
Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications
Measured: Measured at 5 years
Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts
Measured: Measured at 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 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore County
- Responsible party
- Principal investigator, Robert Poston, University of Arizona
- Investigators
- Robert S. Poston, MD, Principal investigator, University of Arizona, Tucson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481806
- Sponsor's protocol ID
- 479
- Other IDs
- R01HL084080-01A1
- Status last verified
- May 2013
- First submitted
- 31 May 2007
- Last updated
- 10 May 2013
- Results posted
- No
Publications
Desai P, Kiani S, Thiruvanthan N, Henkin S, Kurian D, Ziu P, Brown A, Patel N, Poston R. Impact of the learning curve for endoscopic vein harvest on conduit quality and early graft patency. Ann Thorac Surg. 2011 May;91(5):1385-91; discussion 1391-2. doi: 10.1016/j.athoracsur.2011.01.079.
PubMed 21524447Poston RS, Tran R, Collins M, Reynolds M, Connerney I, Reicher B, Zimrin D, Griffith BP, Bartlett ST. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008 Oct;248(4):638-46. doi: 10.1097/SLA.0b013e31818a15b5.
PubMed 18936577
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
- ClinicalTrials.gov ID
- NCT00481806
- Acronym / sponsor ID
- 479
- Conditions
- Coronary Artery Bypass, Thrombosis
- Keywords
- Virchow's Triad, Thrombin, Graft Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore County
- Study start
- Feb 2007
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Jun 2007 (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.
Heart bypass surgery, also known as coronary artery bypass graft (CABG) surgery, creates a detour around the blocked part of a heart artery to restore blood supply to the heart muscle. The saphenous vein, located along the inside of the leg, is commonly used to create the bypass in a CABG surgery. An abnormal increase in the blood clotting protein thrombin may cause the saphenous vein graft to close up and eventually fail. This study will evaluate the relationship between thrombin levels and saphenous vein graft failures in people undergoing a CABG procedure.
Detailed description
The saphenous vein, which runs from the ankle to the groin along the inside of the leg, is commonly used as a graft for people undergoing a CABG surgery. The vein is removed from the leg and reattached to the heart to create a detour around the blocked part of a coronary artery. Following this procedure, many people are prescribed aspirin as a way to increase the chance that the graft procedure will be successful. However, saphenous vein graft failure may still occur in some people, indicating a need to understand why this happens and who might be at risk for graft failure. Thrombin, a protein involved in the blood clotting process, is somehow related to aspirin resistance, abnormalities in blood flow, and cell disruption within the saphenous vein, all factors thought to increase the risk of graft failure. The purpose of this study is to evaluate the likelihood that a burst in thrombin contributes to graft failure in people who have recently undergone a CABG procedure using the saphenous vein.
This study will enroll individuals undergoing CABG surgery at the University of Maryland. Prior to and immediately following surgery, an incision will be made in the skin and the time required for the blood to form a clot will be determined. During surgery, participants' blood vessels will be examined using imaging and cell analysis techniques. Blood collection will occur before surgery, immediately after surgery, and on Days 1, 3, and 30 following surgery. A portion of blood will be frozen for future analysis. An x-ray of the saphenous vein will be performed on Day 5 and again at a follow-up visit 6 to 12 months following surgery. Kidney function will be measured at both of these visits prior to the x-ray procedure. At the second visit, health and mental status questionnaires will be completed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients between the the age of 18-90 years belonging to all races will be enrolled in the study
Key inclusion criteria (2 listed)
- Scheduled for CABG surgery at University of Arizona University Medical Center (UMC)
- For females, willing to use a reliable form of birth control for the duration of the study
Key exclusion criteria (3 listed)
- Non-dermatologic allergy to intravenous (IV) radiographic contrast
- Creatinine levels greater than 2.0 mg/dL
- Pregnant
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
Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation
Time frame: Measured at 5 years
Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG
Time frame: Measured at 5 years
Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications
Time frame: Measured at 5 years
Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts
Time frame: Measured at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Derived from this study: PubMed 21524447Desai P, Kiani S, Thiruvanthan N, Henkin S, Kurian D, Ziu P, Brown A, Patel N, Poston R. Impact of the learning curve for endoscopic vein harvest on conduit quality and early graft patency. Ann Thorac Surg. 2011 May;91(5):1385-91; discussion 1391-2. doi: 10.1016/j.athoracsur.2011.01.079.
- Derived from this study: PubMed 18936577Poston RS, Tran R, Collins M, Reynolds M, Connerney I, Reicher B, Zimrin D, Griffith BP, Bartlett ST. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008 Oct;248(4):638-46. doi: 10.1097/SLA.0b013e31818a15b5.
Related trials for Coronary Artery Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
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Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
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.
Robert S. Poston, MD principal investigator
University of Arizona, Tucson
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 Coronary Artery Bypass and Thrombosis, run by University of Arizona 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert S. Poston, MD (520-626-7951, rposton@surgery.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation (time frame: Measured at 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481806, which also lists 2 linked publications.
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 10 May 2013.