Clinical trial NCT01357499: Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous Coronary Intervention (PCI)
Official title: Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ischemic Heart Disease
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective PCI fulfilling the inclusion and exclusion criteria.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: ST deviation
timeFrame: 120 seconds after angioplasty
Secondary outcomes:
measure: troponin I
timeFrame: 24 hours after PCI
measure: chest pain (Maximum)
timeFrame: time period 2 minutes
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Ernst Moritz Arndt Universität Greifswald
state: MVP
Study officials:
affiliation: Ernst Moritz Arndt University Greifswald
name: Markus Reinthaler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ernst Moritz Arndt University Greifswald
name: Thorsten Reffelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: