- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00481806
Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery
Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Arizona
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Tucson, Arizona, Vereinigte Staaten, 85724
- Rekrutierung
- University of Arizona College of Medicine
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Hauptermittler:
- Robert S. Poston, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Nur Fall
- Zeitperspektiven: Interessent
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation
Zeitfenster: Measured at 5 years
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Measured at 5 years
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Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG
Zeitfenster: Measured at 5 years
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Measured at 5 years
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Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications
Zeitfenster: Measured at 5 years
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Measured at 5 years
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Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts
Zeitfenster: Measured at 5 years
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Measured at 5 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Robert S. Poston, MD, University of Arizona, Tucson
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 479
- R01HL084080-01A1 (US NIH Stipendium/Vertrag)
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