High doses of vascular endothelial growth factor 165 safely, but transiently, improve myocardial perfusion in no-option ischemic disease
| Autor: | Eduardo Ludwig, Renato A. K. Kalil, Roberto T. Sant'Anna, Clarissa Garcia Rodrigues, Bruna Eibel, Paulo R. Prates, Imarilde I. Giusti, João Ricardo M. Sant'Anna, Felipe Borsu de Salles, Sang Won Han, Melissa Medeiros Markoski, Gabriel Grossman, Nance Beyer Nardi, Ivo A. Nesralla, Guaracy F Teixeira Filho |
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| Rok vydání: | 2013 |
| Předmět: |
Male
Vascular Endothelial Growth Factor A medicine.medical_specialty Angiogenesis Ischemia Biology Applied Microbiology and Biotechnology Angina Pectoris Angina Myocardial perfusion imaging Internal medicine Genetics medicine Humans Prospective Studies Prospective cohort study Genetics (clinical) Aged Pharmacology Tomography Emission-Computed Single-Photon medicine.diagnostic_test Myocardial Perfusion Imaging Canadian Cardiovascular Society Genetic Therapy Middle Aged medicine.disease Clinical trial Treatment Outcome Cardiology Exercise Test Molecular Medicine Female Perfusion |
| Zdroj: | Human gene therapy methods. 24(5) |
| ISSN: | 1946-6544 |
| Popis: | Gene therapy can induce angiogenesis in ischemic tissues. The aim of this study was to assess safety, feasibility, and results, both clinical and on myocardial perfusion, of gene therapy in refractory angina. This was a phase I/II, prospective, temporal-controlled series, clinical trial. Thirteen patients were maintained for minimum 6 months under optimized clinical management, and then received intramyocardial injections of 2000 μg plasmid vascular endothelial growth factor 165 and were followed by single-photon emission computed tomography (SPECT), treadmill tests, Minnesota quality of life questionnaire (QOL), and New York Heart Association (NYHA) functional plus Canadian Cardiovascular Society (CCS) angina classifications. There were no deaths, early or late. During the optimized clinical treatment, we observed worsening of rest ischemia scores on SPECT (p0.05). After treatment, there was a transitory increase in myocardial perfusion at the third-month SPECT under stress (pre-operative [pre-op] 18.38 ± 7.51 vs. 3 months 15.31 ± 7.30; p0.01) and at the sixth month under rest (pre-op 13.23 ± 7.98 vs. 6 months: 16.92 ± 7.27; p0.01). One year after, there were improvements in treadmill test steps (pre-op 2.46 ± 2.07 vs.12 months 4.15 ± 2.23; p0.01) and oxygen consumption (pre-op 7.66 ± 4.47 vs.12 months 10.89 ± 4.65; p0.05), QOL (pre-op 48.23 ± 18.35 vs.12 months 28.31 ± 18.14; p0.01) scores, and CCS (pre-op 3 [3-3.5] vs.12 months 2 [1-2.5]; p0.01) and NYHA (pre-op 3 [3-3] vs. 2 [2-2] vs. 12 months 2 [1-2]; p0.01) classes. Gene therapy demonstrated to be feasible and safe in this advanced ischemic cardiomyopathy patient sample. There were improvements in clinical evaluation parameters, and a transitory increase in myocardial perfusion detectable by SPECT scintigraphy.NCT00744315 http://clinicaltrials.gov/ |
| Databáze: | OpenAIRE |
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