NCT01357499

Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous Coronary Intervention (PCI)

Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	blood pressure cuff	A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times.
DEVICE	blood pressure cuff + electric muscle stimulator	A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times. In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle.

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-05-20
• Last updated: 2016-11-16

Locations

1 site across 1 country: Germany