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

University Medicine Greifswald

Status: Withdrawn

Conditions: Ischemic Heart Disease

Treatments: Device: blood pressure cuff + electric muscle stimulator; Device: blood pressure cuff

Study type: Observational

Funder types: Other

Identifiers

NCT01357499

1-reinthaler

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• planned PCI of one of the main coronary artery (artery diameter distal of the stenotic area at least 2,5 mm)
• patient age 18 years or older
• stable angina pectoris symptoms

Exclusion criteria

• presence of collateral vessels
• electrocardiographic bundle branch blocks
• multiple coronary stenosis
• occlusion of a coronary artery
• renal insufficiency (GFR (MDRD) < 50 ml/min/1,73 m2)
• presence of coronary bypass grafts
• history or presence of myocardial infarction.
• echocardiographic signs of left ventricular hypertrophy (septal and/or posterior wall diameter greater than 14 mm)
• some sort of medications (adenosine, morphine and derivates, immunosuppressive agents, oral antibiotics, theophyllin, alpha receptor blockers)
• peripheral arterial disease
• exercise tests performed within 24 h before study start.

Trial design

0 participants in 3 patient groups

control group

Description:

A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg but without inflating the cuff and without stimulating the muscle. Now 25 minutes will have to pass by before beginning the coronary angioplasty.

intervention group 1

Description:

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. There will be no electrical muscle stimulation in this group.

Treatment:

Device: blood pressure cuff

intervention group 2

Description:

A Blood pressure cuff 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

Treatment:

Device: blood pressure cuff + electric muscle stimulator