Post Ten Year Follow up Assessment of a Phase I Trial of Angiogenic Gene Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01174095|
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : May 24, 2017
|Condition or disease|
|Coronary Artery Disease Ischemia|
|Study Type :||Observational|
|Actual Enrollment :||31 participants|
|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|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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".
- Canadian Cardiovascular Society Angina Score [ Time Frame: 10 Years ]
The Canadian Cardiovascular Society Angina Score will be graded as:
Grade I Stable angina develops upon strenuous, rapid, and/or prolonged exertion during work or recreation but is not induced by ordinary physical activity..
Stable angina is characterized by a slight limitation of ordinary activity and is induced by:
Walking uphill or climbing stairs rapidly Walking or stair-climbing after meals Walking more than two level blocks or climbing more than one flight of ordinary stairs at a normal pace and in normal conditions Emotional stress During the few hours after waking
Grade III Stable angina is characterized by marked limitation of ordinary physical activity. It is induced by walking one or two level blocks and climbing one flight of stairs in normal conditions and at a normal pace.
Grade IV Stable angina is characterized by an inability to carry on any physical activity without discomfort. Angina syndrome may be present at rest.
- Survival Rate [ Time Frame: 10 Years ]It is the percentage of people in the study that are still alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174095
|United States, New York|
|Weill Cornell Medicine|
|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|