Post Ten Year Follow up Assessment of a Phase I Trial of Angiogenic Gene Therapy
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 60 - 85 |
| Updated: | 5/25/2017 |
| Start Date: | May 2009 |
| End Date: | May 2012 |
A Post Ten Year Follow up Assessment of a Phase I Trial of Angiogenic Gene Therapy for the Treatment of Coronary Artery Disease Using Direct Intramyocardial Administration of an Adenovirus Vector Expressing the VEGF121 cDNA
The primary aim of the study is to assess and follow-up subjects that received
AdGVVEGF121cDNA in IRB protocol #0794-894 entitled "Phase I Study of Direct Administration
of a Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to
the Ischemic Myocardium of Individuals with Diffuse Coronary Artery Disease" and IRB
protocol #0297-693 entitled "Phase I Study of Direct Administration of a Replication
Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the Ischemic
Myocardium of Individuals with Diffuse Coronary Artery Disease Via Minimally Invasive
Surgery".
AdGVVEGF121cDNA in IRB protocol #0794-894 entitled "Phase I Study of Direct Administration
of a Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to
the Ischemic Myocardium of Individuals with Diffuse Coronary Artery Disease" and IRB
protocol #0297-693 entitled "Phase I Study of Direct Administration of a Replication
Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the Ischemic
Myocardium of Individuals with Diffuse Coronary Artery Disease Via Minimally Invasive
Surgery".
A research coordinator from Weill Cornell Medical College will survey the medical records of
all 31 subjects, and obtain contact information for all living subjects. Living subjects
will be called by the research coordinator at Stony Brook University Medical Center and
invited to participate in the current follow-up study, which will entail a full medical
chart review. If the potential subject is interested, he/she will be invited to Stony Brook
University Medical Center where Dr. Rosengart or a designated co-investigator conducts the
informed consent process. However, subjects who are unable to travel to Stony Brook
University Medical Center will be mailed the consent form. Those who consent to participate
will compile their medical records and send them to Stony Brook University Medical Center.
The research coordinator at Stony Brook will conduct a chart review in order to collect
information regarding the subject's medication, evaluation and surgical history over the
past 10 years. This information will include cardiac health evaluations such as
99mTc-sestamibi SPECT, treadmill exercise tolerance test and cardiac specific blood tests.
These parameters will be compared to evaluations done at baseline and evaluations done at
the subject's last visit as a participant of either Institutional Review Board (IRB)
protocol #0794-894 or #0297-693.
all 31 subjects, and obtain contact information for all living subjects. Living subjects
will be called by the research coordinator at Stony Brook University Medical Center and
invited to participate in the current follow-up study, which will entail a full medical
chart review. If the potential subject is interested, he/she will be invited to Stony Brook
University Medical Center where Dr. Rosengart or a designated co-investigator conducts the
informed consent process. However, subjects who are unable to travel to Stony Brook
University Medical Center will be mailed the consent form. Those who consent to participate
will compile their medical records and send them to Stony Brook University Medical Center.
The research coordinator at Stony Brook will conduct a chart review in order to collect
information regarding the subject's medication, evaluation and surgical history over the
past 10 years. This information will include cardiac health evaluations such as
99mTc-sestamibi SPECT, treadmill exercise tolerance test and cardiac specific blood tests.
These parameters will be compared to evaluations done at baseline and evaluations done at
the subject's last visit as a participant of either Institutional Review Board (IRB)
protocol #0794-894 or #0297-693.
Inclusion Criteria:
- Subjects for this study will be recruited from the population of subjects who
participated in 2 previous Weill Cornell Medical College IRB gene transfer studies
using AdGVVEGF121.10:
1. IRB protocol #0794-894 entitled "Phase I Study of Direct Administration of a
Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121
cDNA to the Ischemic Myocardium of Individuals with Diffuse Coronary Artery
Disease" and
2. IRB protocol #0297-693 entitled "Phase I Study of Direct Administration of a
Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121
cDNA to the Ischemic Myocardium of Individuals with Diffuse Coronary Artery
Disease Via Minimally Invasive Surgery."
Exclusion Criteria:
- Subjects for this study will be recruited from the population of subjects who
participated in 2 previous Weill Cornell Medical College IRB gene transfer studies
using AdGVVEGF121.10:
1. IRB protocol #0794-894 entitled "Phase I Study of Direct Administration of a
Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121
cDNA to the Ischemic Myocardium of Individuals with Diffuse Coronary Artery
Disease" and
2. IRB protocol #0297-693 entitled "Phase I Study of Direct Administration of a
Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121
cDNA to the Ischemic Myocardium of Individuals with Diffuse Coronary Artery
Disease Via Minimally Invasive Surgery."
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