Participants undergoing coronary artery bypass graft will receive veins removed from legs treated with gene therapy and a placebo for grafting. Vein segments are treated at random with either gene therapy or a placebo.
This study is investigating a new gene therapy called Ad5.CMVTO.TIMP-3 for people having a heart bypass operation. During this surgery, doctors use sections of a vein from your leg to create new paths for blood flow to your heart. The problem is these vein grafts can sometimes get blocked over time, leading to further heart problems. This new therapy aims to prevent these blockages. We want to see if it's safe and to find the right dose. Participants will have two sections of their leg vein treated – one with the gene therapy and one with a dummy treatment (placebo). This helps us compare the effects directly within the same person. The study will run from late 2024 to late 2027.
At a glance
What is this study about?
When doctors perform a heart bypass operation, they often use sections of a vein taken from your leg to create new routes for blood to flow around blocked arteries in your heart. These new routes, called grafts, help to relieve symptoms like chest pain or breathlessness caused by heart disease.
While these operations are very common and can greatly improve health, the vein grafts from the leg don't always last forever. Over time, they can become narrowed or blocked, which can lead to further heart problems or the return of symptoms. Despite a lot of research, there isn't currently a specific treatment to stop these vein grafts from failing. This is where our study comes in.
We are looking at a new type of treatment called gene therapy. The main goal of this study is to check if this gene therapy, called Ad5.CMVTO.TIMP-3, is safe when used on the vein grafts. We also want to find out the best amount, or 'dose', to use. By taking part, you would be helping us learn more about this potential new way to keep vein grafts working well for longer, which could benefit many people in the future.
Key takeaways
- This study is testing a new gene therapy for heart bypass patients.
- It aims to prevent vein grafts from getting blocked over time.
- Patients will receive both the gene therapy and a placebo on different vein sections.
- The main goal is to check the safety and find the best dose of the treatment.
- Participation involves your planned bypass surgery and follow-up medical checks.
- It's a Phase I study, meaning it's an early look at a new treatment.
Who may be eligible?
This study is for adults who are planned to have heart bypass surgery. To be eligible, your surgery needs to involve one artery graft (usually from your chest) and at least two vein grafts taken from your leg.
There are some reasons why you might not be able to join. For example, if you've been taking medicines that affect your immune system, or certain anti-cancer treatments in the last three months, you wouldn't be able to take part. Also, if you have certain liver conditions.
For safety reasons, women who are pregnant, breastfeeding, or could become pregnant cannot join the study. Men of child-bearing potential must agree to use effective contraception during the study. It's also important that you are willing to follow all the study's instructions and appointments.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you having a planned heart bypass operation?
- Will your surgery involve at least two vein grafts from your leg?
- Are you willing to attend all study appointments and follow instructions?
- Have you avoided medicines that suppress your immune system or certain anti-cancer treatments in the last 3 months?
- Are you not pregnant, breastfeeding, or planning to become pregnant?
What does participation involve?
If you decide to take part, the study will happen during your planned heart bypass surgery. The surgeons will take two sections of vein from your leg, as they normally would. One section will be treated with the new gene therapy, and the other will be treated with a 'dummy' solution (a placebo) that looks the same but contains no active medicine. Both treatments are applied to the vein sections outside your body for about 30 minutes before they are used as grafts.
After your surgery, you'll be monitored closely in hospital, just as any other patient having bypass surgery. You'll also have scheduled follow-up visits with the study team to check on your health and how the grafts are doing. You'll be asked to attend appointments for clinical review. The study is expected to run from November 2024 to December 2027.
Potential risks and benefits
Locations (1)
- Golden Jubilee National HospitalApproximateClydebank, Scotland
Common questions
What is a heart bypass operation?
It's a surgery where doctors use a healthy blood vessel, often from your leg or chest, to create a new path for blood to flow around a blocked artery in your heart.
What is gene therapy?
Gene therapy is a new type of treatment that aims to change specific genes in cells to treat or prevent a disease. In this study, it's applied to the vein outside your body.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real treatment but contains no active medicine. It helps us see if the real treatment has a specific effect.
Will I know if I received the real gene therapy or the placebo?
No, you won't know which section of vein received the gene therapy and which received the placebo. This helps make the study fair and unbiased, but both will be used in your bypass surgery.
Who is paying for this research?
This study is being funded by the Medical Research Council and the British Heart Foundation, both reputable UK organisations that support medical research.
How to find out more
Lisa Jolly
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.