Post Ten Year Follow up Assessment of a Phase I Trial of Angiogenic Gene Therapy
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Purpose
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".
| Condition |
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Coronary Artery Disease Ischemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | 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 |
| Enrollment: | 31 |
| Study Start Date: | May 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Follow-up Group
The primary aim of the study is to assess and follow-up surviving subjects who received AdGVVEGF121cDNA in either 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" or 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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Detailed Description:
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 IRB protocol #0794-894 or #0297-693.
Eligibility| Ages Eligible for Study: | 60 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
These subjects have clinically significant coronary artery disease (CAD) and have received direct myocardial injection of AdGVVEGF121.10 expressing the human vascular endothelial growth factor (VEGF) 121 cDNA to induce therapeutic angiogenesis.
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:
- 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."
Contacts and Locations| United States, New York | |
| Department of Genetic Medicine, Weill Cornell Medical College | |
| New York, New York, United States, 10021 | |
| Stony Brook University Medical Center | |
| Stony Brook, New York, United States, 11794 | |
| Principal Investigator: | Ronald G Crystal, MD | Weill Medical College of Cornell University |
More Information
No publications provided
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT01174095 History of Changes |
| Other Study ID Numbers: | 0905010396 |
| Study First Received: | July 30, 2010 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
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Diffuse Coronary Artery Disease Ischemic Myocardium Ischemia |
Additional relevant MeSH terms:
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013