PMID- 23944648
OWN - NLM
STAT- MEDLINE
DCOM- 20140325
LR  - 20161125
IS  - 1946-6544 (Electronic)
IS  - 1946-6536 (Linking)
VI  - 24
IP  - 5
DP  - 2013 Oct
TI  - High doses of vascular endothelial growth factor 165 safely, but transiently, 
      improve myocardial perfusion in no-option ischemic disease.
PG  - 298-306
LID - 10.1089/hgtb.2012.221 [doi]
AB  - 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 mug 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 (p<0.05). 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; p<0.01) and at the sixth month under rest (pre-op 
      13.23 +/- 7.98 vs. 6 months: 16.92 +/- 7.27; p<0.01). One year after, there were 
      improvements in treadmill test steps (pre-op 2.46 +/- 2.07 vs.12 months 4.15 +/- 
      2.23; p<0.01) and oxygen consumption (pre-op 7.66 +/- 4.47 vs.12 months 10.89 +/- 
      4.65; p<0.05), QOL (pre-op 48.23 +/- 18.35 vs.12 months 28.31 +/- 18.14; p<0.01) 
      scores, and CCS (pre-op 3 [3-3.5] vs.12 months 2 [1-2.5]; p<0.01) and NYHA 
      (pre-op 3 [3-3] vs. 2 [2-2] vs. 12 months 2 [1-2]; p<0.01) 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. 
      CLINICAL TRIAL REGISTRATION: NCT00744315 http://clinicaltrials.gov/
FAU - Giusti, Imarilde I
AU  - Giusti II
AD  - 1 Instituto de Cardiologia, Fundacao Universitaria de Cardiologia , Porto Alegre, 
      90620-000 Brazil .
FAU - Rodrigues, Clarissa G
AU  - Rodrigues CG
FAU - Salles, Felipe B
AU  - Salles FB
FAU - Sant'Anna, Roberto T
AU  - Sant'Anna RT
FAU - Eibel, Bruna
AU  - Eibel B
FAU - Han, Sang W
AU  - Han SW
FAU - Ludwig, Eduardo
AU  - Ludwig E
FAU - Grossman, Gabriel
AU  - Grossman G
FAU - Prates, Paulo Roberto L
AU  - Prates PR
FAU - Sant'Anna, Joao Ricardo M
AU  - Sant'Anna JR
FAU - Filho, Guaracy F Teixeira
AU  - Filho GF
FAU - Markoski, Melissa M
AU  - Markoski MM
FAU - Nesralla, Ivo A
AU  - Nesralla IA
FAU - Nardi, Nance B
AU  - Nardi NB
FAU - Kalil, Renato A K
AU  - Kalil RA
LA  - eng
SI  - ClinicalTrials.gov/NCT00744315
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hum Gene Ther Methods
JT  - Human gene therapy methods
JID - 101573202
RN  - 0 (VEGFA protein, human)
RN  - 0 (Vascular Endothelial Growth Factor A)
SB  - IM
MH  - Aged
MH  - Angina Pectoris/diagnostic imaging/*therapy
MH  - Exercise Test
MH  - Female
MH  - *Genetic Therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Perfusion Imaging
MH  - Prospective Studies
MH  - Tomography, Emission-Computed, Single-Photon
MH  - Treatment Outcome
MH  - Vascular Endothelial Growth Factor A/*genetics/metabolism
EDAT- 2013/08/16 06:00
MHDA- 2014/03/26 06:00
CRDT- 2013/08/16 06:00
PHST- 2013/08/16 06:00 [entrez]
PHST- 2013/08/16 06:00 [pubmed]
PHST- 2014/03/26 06:00 [medline]
AID - 10.1089/hgtb.2012.221 [doi]
PST - ppublish
SO  - Hum Gene Ther Methods. 2013 Oct;24(5):298-306. doi: 10.1089/hgtb.2012.221.