The DOI matches its Crossref record; 12 of the 12 references it cites were found in a registry or an index.
Randomized, Single-Blind, Placebo-Controlled Pilot Study of Catheter-Based Myocardial Gene Transfer for Therapeutic Angiogenesis Using Left Ventricular Electromechanical Mapping in Patients With Chronic Myocardial Ischemia
Open accessAbstract
Background —Catheter-based myocardial gene transfer (GTx) has not been previously tested in human subjects. Accordingly, we performed a pilot study to investigate the feasibility and safety of catheter-based myocardial GTx of naked plasmid DNA encoding vascular endothelial growth factor-2 (phVEGF-2) in patients with chronic myocardial ischemia. Methods and Results —A steerable, deflectable 8F catheter incorporating a 27-guage needle was advanced percutaneously to the left ventricular myocardium of 6 patients with chronic myocardial ischemia. Patients were randomized (1:1) to receive phVEGF-2 (total dose, 200 μg), which was administered as 6 injections into ischemic myocardium (total, 6.0 mL), or placebo (mock procedure). Injections were guided by NOGA left ventricular electromechanical mapping. Patients initially randomized to placebo became eligible for phVEGF-2 GTx if they had no clinical improvement 90 days after their initial procedure. Catheter injections (n=36) caused no changes in heart rate or blood pressure. No sustained ventricular arrhythmias, ECG evidence of infarction, or ventricular perforations were observed. phVEGF-2–transfected patients experienced reduced angina (before versus after GTx, 36.2±2.3 versus 3.5±1.2 episodes/week) and reduced nitroglycerin consumption (33.8±2.3 versus 4.1±1.5 tablets/week) for up to 360 days after GTx; reduced ischemia by electromechanical mapping (mean area of ischemia, 10.2±3.5 versus 2.8±1.6 cm 2 , P =0.04); and improved myocardial perfusion by SPECT-sestamibi scanning for up to 90 days after GTx when compared with images obtained after control procedure. Conclusions —This randomized trial of catheter-based phVEGF-2 myocardial GTx provides preliminary indications regarding the feasibility, safety, and potential efficacy of percutaneous myocardial GTx to human left ventricular myocardium.
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Cites
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Nonfluoroscopic, in vivo navigation and mapping technology
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Cited by
Vascular Endothelial Growth Factor and Angiogenesis
Hoeben, A., Landuyt, B., Highley, M. S., Wildiers, H., Van Oosterom, A. T., & De Bruijn, E. A. (2004) · Pharmacological Reviews · doi:10.1124/pr.56.4.3 · Cited by 1,824
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Vascular Endothelial Growth Factors
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Self-citationKusano, K. F., Pola, R., Murayama, T., Curry, C., Kawamoto, A., Iwakura, A., Shintani, S., Ii, M., Asai, J., Tkebuchava, T., et al. (2005) · Nature Medicine · doi:10.1038/nm1313 · Cited by 304
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Metadata
- Authors
- Vale, P. R., Losordo, D. W., Milliken, C. E., McDonald, M. C., Gravelin, L. M., Curry, C. M., Esakof, D. D., Maysky, M., Symes, J. F., & Isner, J. M.
- Venue
- Circulation
- Published
- 2001-05
- Volume
- 103
- Issue
- 17
- Pages
- 2138-2143
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W1993966328
- Cited by
- 307
- References
- 12
- FWCI
- 32.29
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Vale, P. R., Losordo, D. W., Milliken, C. E., McDonald, M. C., Gravelin, L. M., Curry, C. M., Esakof, D. D., Maysky, M., Symes, J. F., & Isner, J. M. (2001). Randomized, Single-Blind, Placebo-Controlled Pilot Study of Catheter-Based Myocardial Gene Transfer for Therapeutic Angiogenesis Using Left Ventricular Electromechanical Mapping in Patients With Chronic Myocardial Ischemia. Circulation. https://doi.org/10.1161/01.cir.103.17.2138
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