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

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".

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Ischemia Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medicine, New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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."

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:

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."

Treatment and study plan

Primary outcomes

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..

Grade II

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.

Secondary outcomes

Survival Rate

Time frame: 10 Years

It is the percentage of people in the study that are still alive.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Stony Brook University

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Aug 3, 2010
Registry last updated: May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed