Peripheral Vascular Disease Clinical Trial
Official title:
Randomised Controlled Trial to Evaluate the Reno-protective Benefits of Remote Ischaemic Preconditioning in Patients Undergoing Infrainguinal Peripheral Angioplasty
This study aims to demonstrate if remote ischaemic preconditioning (RIPC) may confer renal protection in patients undergoing peripheral angioplasty. Patients will be randomised to receive RIPC and biomarkers for renal injury will be analysed post procedure to determine if any protective benefit was obtained.
Ischaemic preconditioning is an endogenous mammalian mechanism whereby a brief period of
ischaemia and reperfusion confers resistance to subsequent prolonged ischaemic insults.
First observed in the canine heart, subsequent investigators noted that brief ischaemia in
remote organs e.g. skeletal muscle, induced protection in key central organs e.g. the heart.
This remote ischaemic preconditioning (RIPC) does not require direct interference with the
target organs' blood supply. It can be induced using blood pressure cuffs to produce brief
episodes of upper limb ischaemia and reperfusion and confers protection upon numerous organs
simultaneously. RIPC reduces myocardial injury following aortic aneurysm repair, cardiac
surgery and angioplasty. It also reduces adverse ischaemic events up to six months following
percutaneous coronary intervention, implying some medium-term effect.
To date ischaemic conditioning has been applied primarily to the heart however animal
studies have shown pre conditioning to offer renal protection.
Fikret et al in 2012 in the Renal Protection Trial demonstrated a protective benefit with
RIPC from the development of CIN in high risk patients undergoing elective coronary
angiography.Whittaker and Przyklenk in 2011 explored this concept retrospectively using data
from patients who had undergone emergency angioplasty for ST elevation myocardial
infarction. The original trial was a RCT which examined the protective effect of
postconditioning on myocardial ischemia. The authors retrospectively examined if study
patients treated with multiple coronary balloon inflations had better renal function than
patients not exposed to this remote conditioning. They concluded that patients in the
conditioning group received 25% more contrast volume than the control group and showed no
decline in renal function as demonstrated by examination of glomular filtration rate at day
3 post procedure in comparison to the control group which saw a significant decline in renal
function. The need for contrast-based procedures is rising, with increasing numbers of
patients undergoing endovascular procedures, as is the incidence of postcontrast renal
failure, which has a reported mortality of 34%. The potential use of RIPC therefore to
reduce the risk of kidney damage needs further investigation in a prospective study and the
PAD patient group who are routinely exposed to contrast administration in angiography are an
ideal study group.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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