Basic Science Research Technology * Clinical Research Program

Basic Science Research Technology

The Vascular Research Laboratory in its current form was established by Dr. Louis Messina in 2006. He has enjoyed continuous extrinisic NIH funding for well over a decade. He also currently serves as the associate editor for The Journal of Vascular Surgery.

Current projects include the study of:

1. Mollecular and cellular mechanisms regulating colleteral artery enlargement.

2. Effect of hypercholesterolemia and diabetes-induced oxidative stress on hematopoietic stem cells: unbalanced lineage differentiation and accelerated aging.

3. Hypercholesterolemia leads to abnormal T-Cell Development and icreased risk of cancer.

4. Diabetes (db/db) abnormal myeloid development and impaired wound healing.

Clinical Research Program

1. Silent myocardial ischemia detected by vector cardiography in the post-operative vascular surgical patient.
Now three years into data accumulation, the protocol using the Hewlett-Packard ST-segment analysis program has completed phase I study. Results have shown efficacy and feasibility of perioperative monitoring in vascular surgical patients with sensitive detection of EKG changes in the first 24-48 hours following surgery. Under the direction of Dr. Bruce Cutler, this data will allow for the development of a treatment/intervention based protocol utilizing the information obtained from the monitoring system to implement clinical treatment strategies to prevent significant perioperative myocardial events. Further funding will be sought from industry to update the equipment and embark on phase II study.
2. WHO-4 Study: Evaluation of Repifermin in Venous Stasis Ulceration
Dr. Michael Rohrer is principal investigator in the UMass-Memorial Venous Clinic site for this clinical protocol studying the efficacy of KGF-2 (Repifermin) in the treatment of venous stasis ulceration. Enrollment is underway with the first several patients recruited. Ongoing recruitment/enrollment will continue in 100 centers for a total of ~700 patients. Itis expected that this project will carry on for the next 1-2 years.
3. Risk factor identification and modulation in patients with peripheral arterial disease
Maria Cote, RN, Clinical Director of the Vascular Health Center, performed and presented (Society of Vascular Nursing) a prospective analysis of management of hypercholesterolemia in vascular surgical patients. Her research showed that only a small percentage of patients planned to undergo peripheral vascular surgery had had their lipid profile adequately evaluated and even fewer were appropriately treated according to the National Cholesterol Education Program Guidelines. In addition, the Vascular Health Center has also incorporated an aggressive smoking cessation program achieving a greater than 30%success rate. Under the direction of Maria, and Dr. James Froehlich, funding from the American Heart Association and the Lifeline Foundation will be sought to design and carry out a prospective analysis of implementation of a rigorous management scheme based on this preliminary data. We hope to have funding and the project underway this year.
4. Randomized, Placebo-Controlled, 12-week Multicenter Study of Remodulin in Patients with Nonreconstructible Critical Limb Ischemia.
Dr. Bruce Cutler is the principal investigator of this collaborative study with United Therapeutics Corporation. The study is designed to assess and compare the safety of continuous and daily subcutaneous injection of treprostinil sodium (Remodulin) in patients with critical limb ischemia not intended for revascularization. Outcomes studied include effects on wound healing, rest pain, treadmill claudication, limb salvage, quality of life, ambulatory living status, and mortality.
5. Multicenter Study of the Effect of Lovastatin and Niacin in Claudication.
This is our newest study planned to start the first of the year and is again headed up by Dr. Cutler. This will be an organized prospective randomized study of the effects combination therapy with lovastatin and niacin in patients with intermittent claudication. Study endpoints will include improvements in treadmill performance and changes in quality of life, as well as, effects on lipid profiling.
6. Reducing Risk Factors in Peripheral Arterial Disease.
This is a multicenter study submitted for NIH consideration. Dr. James Froehlich is the local co-investigator in this collaborative study with Northwestern University in Chicago. Similar to our local endeavors in the Vascular Health Center to evaluate and systematically treat cardiovascular risk factors in patients with peripheral arterial disease, this program looks at a nurse-mediated telephone counseling intervention protocol to improve management of dyslipidemia in PAD patients. If funded, patient accrual with start next Spring.
7. Study of conservative and pharmacologic treatments for intermittent claudication based on anatomical criteria of peripheral vascular disease
Dr. Bruce Cutler has been principal investigator on several studies evaluating the use of risk factor modification and cilostazol pharmacologic intervention showing benefit in patients with intermittent claudication. We plan to submit a proposal for additional industry support to evaluate if the benefit achieved is equivalent for patients presenting anatomically with aortoiliac disease versus femoropopliteal disease. This would first be a post hoc review and subset analysis of the previous study data to determine feasibility, followed by a prospective comparison of treatment algorithms between patients with disease in the two distributions.
8. Study of Carotid Artery Duplex Velocities in the Pediatric Patient Population.
Dr. Michael Singh looks to characterize the normal flow velocity and waveform morphology on duplex ultrasonography of the carotid arteries in the pediatric population. The goal is to define the range of normal values and to compare these to potentially abnormal values achieved in children admitted for trauma or other presenting problems.