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Fibroblast
Growth Factor (rFGF-2)
Phase II Clinical
Trial |
rFGF-2: Recombinant FGF-2 is almost identical to FGF, a naturally occurring
protein. FGF-2 is stored primarily in the endothelial basement membrane
and is known to promote angiogenesis by acting as an endothelial cell
mitogen. The stimuli for the synthesis and secretion of fibroblast
growth factors are not well understood, although cellular injury,
as occurs in myocardial ischemia or infarction, is thought to be one
such stimulus.
Primary Objective: To compare
the effect of a single, intracoronary infusion of rFGF-2 vs placebo
on exercise capacity. Secondary objectives include: change in quality
of life and changes from baseline in the size of the ischemic area.
Inclusion Criteria:
| 1. |
Patients with CAD with persistent
myocardial ischemia despite optimal medical management and are
not candidates for standard surgical or catheter-based revascularization
procedures or the patient refuses such therapies. |
| 2. |
Angiography within 6 months revealing
>60% stenosis of a major coronary artery. |
| 3. |
Inducible or Reversible ischemic
defect of moderate or greater size on a rest/stressed thallium/sestamibi
scan. |
| 4. |
EF >30% |
| 5. |
Symptoms of angina or angina
equivalent |
| 6. |
Able to exercise on a treadmill
for at least 3 minutes |
| 7. |
Serum creatinine < 1.5 |
Exclusion Criteria:
| 1. |
Malignancy: History or
suspicion of malignancy within past 10 years |
| 2. |
Renal Conditions: creatinine
> 1.5 or proteinuria |
| 3. |
Ocular Conditions: Proliferative
retinopathy, age-related maculopathy |
| 4. |
Cardiovascular: Severe
AS, USA, Pulmonary HTN, Cardiomyopathy (restrictive or or obstructive)
or any of the following within 6 months: MI, CABG, TIA, or Stroke |
| 5. |
Medical: Pregnant or nursing
females, pathological fibrosis or known vascular malformations
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Screening: (To
be completed by study personnel) Includes: Cancer screening (PSA,
mammography, papsmear, etc.) full H & P, eye exam, chest x-ray,
2 exercise treadmill tests (ETT), & Dipyridamole/Thallium
(DT) sestamibi.
Treatment: rFGF-2 (3 different dosages) or placebo infusion given intracoronary.
Follow-up: Holter monitor for first 48 hrs, 2 ETTs (@ 3 & 6 mos.), 2 DT sestamibis
( @3 & 6 mos.) & eye exam ( @6 mos.)
Patients will not incur any cost for screening,
treatment or follow-up procedures.
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If you have a patient that may be
eligible for this clinical trial please contact, Andrew Michaels,
Co-director of the Cath Lab, 415.514.2104
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Text provided by Andrew Michaels,
M.D., Tony Chou, M.D., and Laura Kee, R.N., Ph.D.,
Division of Cardiology, University of California San Francisco
Copyright © 2001 All Rights Reserved
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