Ischemic Heart Disease Clinical Trial
Official title:
Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
The purpose of this study is to investigate if remote ischemic preconditioning by combining limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better results in preconditioning the human heart than limb ischaemia alone does.
It has been demonstrated that protection from ischemia reperfusion can be achieved by brief
periods of ischemia applied at a remote site during an injurious ischemic event (remote
postconditioning). The purpose of this study is to investigate if the combination of brief
periods of limb ischemia in combination with electric muscle stimulation at the same site
could exceed the preconditioning effect of limb ischemia alone.
Therefore the investigators thought to perform 2 different forms of remote ischaemic
preconditioning in patients undergoing elective coronary angioplasty.
In the first patient group a blood pressure cuff will be applied at the lower leg. Ischemia
will be induced by inflating the cuff to a pressure of 200 mmHg for 5 minutes. Afterwards
reperfusion will be allowed for further 5 minutes. This cycle will be repeated 3 times.
In a second patient group electric muscle stimulation at the same site (HiToP 191) will be
performed additionally throughout the whole preconditioning cycle.
After preconditioning, the percutaneous coronary intervention (PCI) will be performed by 3
PCI-ballon inflations, each lasting for 2 minutes. Between the inflations coronary
reperfusion will be allowed for 5 minutes.
The Effects of preconditioning will be evaluated by analysing the ST-deviation, caused by
angioplasty in an intracoronary (derived by PCI wire) and surface ecg.
Also the maximum of chest pain during the 3 inflation cycles and troponin levels 24 h after
PCI will be evaluated.
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Observational Model: Case Control, Time Perspective: Prospective
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