PROTECT

• Research type

  Research Study

• Full title

  A randomised Placebo-contROlled Trial of Ad5.CMVTO.TIMP-3 to prEvent Coronary artery bypass grafT failure

• IRAS ID

  1010338

• Contact name

  Colin Berry

• Contact email

  Colin.Berry@glasgow.ac.uk

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• ISRCTN Number

  ISRCTN43650325

• Research summary

  Coronary artery bypass graft (CABG) is recommended in clinical guidelines for the treatment of multivessel and/or left main obstructive coronary atherosclerosis (fatty plaque). Typically, the CABG operation involves three ‘bypass grafts’. The surgeon will harvest a saphenous vein from the leg, and divide the vein into two or three segments for use as grafts. The surgeon will also dissect the internal mammary artery to use as an additional graft. During the surgery, the saphenous veins are connected to the aorta and the coronary arteries to ‘bypass’ blockages in the right coronary artery and the left obtuse marginal coronary artery. The mammary artery is grafted to the left anterior descending artery which is the main branch of the left coronary artery.
  The CABG operation is routinely undertaken in cardiothoracic centres worldwide. In the West of Scotland, the cardiac surgery services are provided by the NHS Golden Jubilee National Hospital as part of a regional model of integrated care. Patients with ischaemic symptoms, such as angina and myocardial infarction, are referred by cardiologists to the multidisciplinary team meeting where a consensus-based care plan is established for individual patients.
  Patients who undergo CABG surgery have an appreciable likelihood of developing recurrent angina and experiencing a heart attack in the longer term. Although the artery graft works well life-long, on exposure to arterial levels of blood pressure, the vein grafts undergo maladaptive remodelling in the longer term. The mechanism involves neointima formation, wall thickening, lumen loss and progressive occlusion limiting the flow of blood from the aorta to the heart. Despite intensive biomedical research and clinical trials during the past three decades, there are no preventive treatments for vein graft disease, and vein graft failure post-CABG presents an unmet therapeutic need.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0395

• Date of REC Opinion

  6 Feb 2025

• REC opinion

  Further Information Favourable Opinion