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

This study has been completed.
Sponsor:
Collaborator:
Stony Brook University
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01174095
First received: July 30, 2010
Last updated: December 20, 2012
Last verified: December 2012
  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
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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
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."

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
Study Population

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.

Criteria

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."
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174095

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
Sponsors and Collaborators
Weill Medical College of Cornell University
Stony Brook University
Investigators
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:
Diffuse Coronary Artery Disease
Ischemic Myocardium
Ischemia

Additional relevant MeSH terms:
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 April 23, 2014