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VEGF-2:
Physican Information
Principal
Investigator:
Tim Henry, M.D.
Co-Investigators:
Joseph Van Camp, M.D., R. Michael King, M.D., Brad Bart, M.D., Charles
Herzog, M.D., Richard Manka, M.D.
Coordinators:
Charlene Boisjolie, R.N., Maria Pyle, L.P.N.
Study
Drug: Gene for Vascular Endothelial Growth Factor 2 (VEGF-2)
Study
Population: Coronary artery disease with stable class 3 or 4 angina,
and areas of viable but underperfused myocardium who are not ideal candidates
for revascularization procedures.
Study
Design: Multi-center, Phase 2a, open-label, dose-escalating, safety
and effectiveness study in 30 patients.
Entry
Criteria:
Inclusion:
- Age >
21
- Stable
Class 3 or 4 angina
- Areas
of viable but underperfused myocardium
- Multivessel
occlusive CAD and/or occlusion of one or more CABG
- No contraindications
to general anesthesia or minithoracotomy
- Agree
to participate in a 9-month follow-up study
Exclusion:
- Ocular
conditions: diabetic retinopathies, age-related macular degeneration
- Previous
involvement with an investigational drug within 1 month prior to VEGF-2
- Previous
involvement with investigational angiogenic growth factor
- CABG or
angioplasty within last 3 months
- Severe
concurrent illness
- Unable
to undergo cardiac catheterization or nuclear testing
Drug
Therapy: Intramyocardial injection: Patients will undergo a minithoracotomy
during which the gene for VEGF-2 will be injected into the ischemic zone
of the myocardium at 4 separate injection sites.
Concomitant
Therapies: Patients will be treated by their personal physicians with
routine medications as needed. No restriction of medication will be stipulated.
Other
Study Requirements:
Pre-treatment:
- Coronary
angiography
- Adenosine
sestamibi scan
- Exercise
tolerance test
- 12-lead
ECG, CXR, echocardiogram
- Opthalmoscope
examination for diabetics
- Mammography
within one year for female patients, PSA for males
Post-treatment:
- Coronary
angiography
- Adenosine
sestamibi scan
- Exercise
tolerance test
- 12-lead
ECG, CXR, echocardiogram
- Opthalmoscope
examination for diabetics
- 12-month
follow up includes periodic stress tests and physical exams
Contact
Phone Numbers:
HCMC Cardiology Office: (612) 347-2875
Study Coordinators:
Charlene
Boisjolie, R.N. (612) 347-3704
Maria
Pyle, L.P.N. (612) 347-7636
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