NCT01174095

Post Ten Year Follow up Assessment of a Phase I Trial of Angiogenic Gene Therapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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".

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 Institutional Review Board (IRB) protocol #0794-894 or #0297-693.

Conditions

• Coronary Artery Disease
• Ischemia

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-08-03
• Last updated: 2017-05-24

Locations

2 sites across 1 country: United States