The Venous Study
Research type
Research Study
Full title
Safety and efficacy of coronary venous arterialisation in patients with refractory angina: a prospective, protocol based case series - The Venous Study
IRAS ID
249827
Contact name
Gianni Angelini
Contact email
Sponsor organisation
UH Bristol NHS Foundation Trust
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Angina is a heart condition. It occurs when the blood vessels (arteries) that supply blood to the heart become hardened and narrowed, restricting blood flow to the heart. Angina is usually treated with medications, angioplasty or surgery. Angioplasty involves opening the narrowed artery using a metal tube called a stent. Coronary artery bypass surgery (CABG) involves bypassing the narrowed artery(s) with healthy blood vessel segments taken from other parts of the body. A small proportion of patients are not suitable for angioplasty or CABG because their arteries are too diseased or small. These patients have few treatment options and poor quality of life.\nWe propose a novel surgery to try and restore blood flow to the heart. Instead of connecting the graft to an artery as in CABG, we will connect it to a vein. This is called coronary arterial venous grafting (CAVG). The veins run parallel to the arteries but blood normally flows through them in the opposite direction. Therefore blood through the vein needs to be reversed. Another method of restoring blood flow using veins is to attach the bypass graft to the large blood vessel behind the heart that is formed by a collection of veins (the coronary sinus), known as coronary sinus grafting (CSG).\nWe will conduct a case series, in which a group of patients will be given CAVG or CSG and followed up for one year. The surgeries will be video-recorded to document the development of the surgical procedures. We will determine whether: the procedures are safe, the grafts remain viable, blood flow to the heart increases, angina symptoms improve, and patients experience improved quality of life. We will conduct a sub-study involving interviews and audio-recording of consultations between healthcare professionals and patients to understand how information about the study is communicated to patients.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0163
Date of REC Opinion
13 Aug 2018
REC opinion
Unfavourable Opinion