Trial Information

Summary: Inflammation and Insulin Resistance in PAD

Inflammation and Insulin Resistance in Vein Bypass Surgery

Peripheral arterial disease (PAD) is caused by atherosclerosis (hardening and narrowing) of the arteries to the leg. It is a highly prevalent disease affecting 8-10 million Americans. Patients with PAD are at an increased risk for cardiovascular (heart/blood vessels) events, including myocardial infarction (MI) (heart attack), stroke, and death. In addition, patients can also suffer from symptoms of claudication (pain in the legs while walking/exercising) and ulcerations on their lower extremities. One method of treatment is bypass surgery using vein from the arm or leg. Bypass grafts are quite successful overall, but they can become blocked off over time. Graft stenosis (blockage) or failure occurs in as many as 50% of individuals over a five to ten year span. At that time, the patient may require another intervention such as surgery or angioplasty.

The objective of our research study is to see if inflammation is associated with the incidence and progression of vein graft disease and PAD. Subjects will get a sample of blood drawn pre-operatively and post-operatively (at 3 months follow-up) for analysis of a panel of inflammatory markers (i.e. high-sensitivity C-reactive protein, fibrinogen, etc.). For some patients, the inflammatory markers will be correlated with ultrasound and MRA imaging of the bypass graft for one year after the procedure. These images will be examined to determine if there is a relationship between inflammatory marker levels and graft lumen diameter and wall thickness.

The primary endpoint of the study is the occurrence of vein graft failure (i.e. blockage of the graft, major amputation of the index limb, etc.) at one year. Secondary study endpoints include all cause mortality (death), surgical and long term (5-year) cardiovascular complications (i.e. stroke, heart attack, etc), and the need for vascular intervention or amputation of the contralateral (other side) limb.

Study recruitment will continue until August 2008. Our recruitment goal is 360 patients. This study will be performed at three centers – Brigham and Women’s Hospital, West Roxbury VA, and Beth Israel Deaconess Medical Center (Boston, MA).

For more information, please contact Dr. Michael Conte (Principal Investigator) at 617-732-6816 or Diana Kim (Research Manager) at 617-732-4778.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.