STEMI-Cool Randomised Controlled Trial
Research type
Research Study
Full title
Trans-coronary cooling and dilution to reduce reperfusion injury during revascularisation for ST-Elevation Myocardial Infarction.
IRAS ID
315559
Contact name
Miles Dalby
Contact email
Sponsor organisation
Guys & St Thomas NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A heart attack occurs when a coronary artery supplying blood to the heart suddenly blocks causing muscle damage. Large heart attacks can cause breathlessness, fluid retention and death. Patients presenting to hospital with a heart attack usually undergo an immediate angiogram, passing a fine plastic tube (catheter) through the wrist to take x-ray pictures and identify the blockage. Blockages can usually be opened by passing a stent (a thin metal mesh tube) over a fine wire and expanding it into position. This procedure known as primary angioplasty restores blood flow to the heart and reduces heart muscle damage.
Although primary angioplasty is very successful, sudden restoration of blood flow can cause damage to the heart muscle when the artery is opened. Cooling the entire body has been shown to reduce this problem, but is uncomfortable, expensive and can cause treatment delays.
We are conducting a series of studies to find out if cooling the heart muscle directly with fluid through the catheter being used for primary angioplasty treatment may be effective in reducing heart attack damage. We have already published an initial series of ten cases in which this treatment appeared to be feasible without causing significant clinical problems.
The present study will randomise 60 patients with 30 allocated to this new treatment and 30 to usual care. It will assess primarily the rate of patient recruitment, feasibility and safety of this new treatment while also exploring some detailed outcomes measuring the restoration of blood flow in the coronary artery at the end of the procedure. Ultimately if the present pilot study is successful, we plan to go on to undertake a much larger randomised outcome study to determine definitively whether this treatment can help reduce heart attack size and therefore benefit patients.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
23/YH/0035
Date of REC Opinion
27 Feb 2023
REC opinion
Favourable Opinion