CLINICAL TRIALS NEWS

Study of the SafeSeal Hemostasis Patch Flowing Percutaneous Coronary Artery and Peripheral Vascular Interventions is a phase IV, randomized, open-label, active control, parallel assignment study to determine the safety and efficacy of using the SafeSeal hemostasis patch in an effort to reduce the time to hemostasis and time to ambulation, compared with standard manual compression after arterial sheath removal following these vascular interventions. The study is currently recruiting patients of either gender aged 18 years or older who are undergoing coronary or peripheral vascular intervention using a 6 French arterial sheath, with overnight hospitalization following the procedure. Exclusion criteria include hematoma or persistent bleeding around the vascular sheath, previous arteriovenous fistula or pseudoaneurysm in the ipsilateral femoral artery, and a history of bleeding diathesis or coagulopathy. Patients will be randomized to sheath removal using manual compression alone or manual compression using the hemostasis patch. The primary outcome measures are time to achieve hemostasis of femoral artery after the arterial sheath is removed and vascular access-related bleeding complications prior to discharge. The study, which is sponsored by the University of Rochester (N.Y.) and Possis Medical, began in May 2007, and has a total expected enrollment of 150 patients, with an expected completion in December 2007. The ClinicalTrials.gov identifier is NCT00481741.

Effect of Steroids, Controlling Blood Sugar Levels, and Avoidance of Deep Anesthesia on Patient Outcomes After Major Vascular Surgery is a randomized, double-blind, placebo-controlled, parallel-assignment study to determine the safety and efficacy of using corticosteroids, intensive control of blood sugar levels, and avoidance of deep anesthesia on major vascular surgery. The study is currently recruiting patients of either gender aged 50 years or older who are scheduled for major peripheral vascular surgery or open abdominal aortic aneurysm surgery. Exclusion criteria include recent steroid therapy (within 30 days), isolated carotid endarterectomy, and American Society of Anesthesiologists physical status less than 4. The treatment arms will compare intensive vs. conventional glucose management and lighter vs. deeper anesthetic, as well as dexamethasone vs. placebo. The primary outcome measure is the incidence and rate of major perioperative morbidity. Secondary outcomes include reduction of circulating concentrations of the inflammatory marker CRP, incidence and rate of minor surgical complications, time to discharge, postoperative quality of life, and all-cause 1-year mortality. The study, sponsored by the Cleveland Clinic and Aspect Medical Systems, began February 2007 with an expected enrollment of 984 patients. The ClinicalTrials.gov identifier is NCT00433251.

The Effect of Diet on Vascular Disease: A Study of Pre-Menopausal African American and Caucasian Wom is a prospective study to determine if the adverse effects of triglyceride levels occur at a lower level in African Americans than in Caucasians. As a population, African Americans are more insulin resistant and have a higher rate of vascular disease than Caucasians, but also have lower triglyceride levels. Patients will be broken into two groups (24 African American, 24 Caucasian) and studied to determine if there are differences in the effect of a meal on triglyceride levels and vascular function. Vascular function will be determined via blood pressure and blood flow measurements with ultrasound. Inclusion criteria include female patients between 18 and 49 years who have a normal complete blood count, glucose, BUN creatinine, liver and thyroid panels and are either African Americans or Caucasians born in the United States, with both parents of the same race and born in the United States. Exclusion criteria include hysterectomy, pregnancy, current smokers, oral contraceptives, and refusal to use barrier contraception or abstinence. The study, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, began June 2007 and is currently recruiting. It has an expected enrollment of 48 patients. The ClinicalTrials.gov identifier is NCT00484861.