- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00481806
Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery
Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
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Arizona
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Tucson, Arizona, Forente stater, 85724
- Rekruttering
- University of Arizona College of Medicine
-
Hovedetterforsker:
- Robert S. Poston, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-dermatologic allergy to intravenous (IV) radiographic contrast
- Creatinine levels greater than 2.0 mg/dL
- Pregnant
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation
Tidsramme: Measured at 5 years
|
Measured at 5 years
|
Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG
Tidsramme: Measured at 5 years
|
Measured at 5 years
|
Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications
Tidsramme: Measured at 5 years
|
Measured at 5 years
|
Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts
Tidsramme: Measured at 5 years
|
Measured at 5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Robert S. Poston, MD, University of Arizona, Tucson
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Poston 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 479
- R01HL084080-01A1 (U.S. NIH-stipend/kontrakt)
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