| 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. |
