Purpose of this Study
People in this study will have tests before they start. These tests include blood work, a heart check called an electrocardiogram, pictures of the heart, a chest x-ray, and answering questions on forms. If they can join, they will be put into one of two groups by chance. One group will get a medicine called XC001, and the other group will get a placebo. Both will be given as shots into the heart muscle during surgery. After surgery, there will be check-up visits at 2 weeks, and then at 1, 3, 6, and 12 months. These visits will include the same tests as before.
Who Can Participate?
Eligibility
- Adults 18-80 years old
- Coronary artery disease needing surgical revascularization
- Increased likelihood of incomplete revascularization due to anatomical factors
- Has not had a heart attack or stroke withing the past 60 days
Age Range
18-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The goal of this study is to find out if a medicine called XC001 works for people who have heart disease and need a surgery called coronary artery bypass. XC001 is made from a virus that has been changed so it can carry something called VEGF to the heart. VEGF helps new blood vessels grow. This can improve blood flow to the heart and help it stay healthy.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization
Principal Investigator
Adam
Williams
Protocol Number
PRO00118712
NCT ID
NCT07118449
Phase
II
Enrollment Status
Pending Open to Enrollment