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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Markus Reinthaler, University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01357499
First received: May 10, 2011
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Device: blood pressure cuff
Device: blood pressure cuff + electric musclestimulator
Phase 0

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • st deviation [ Time Frame: 120 seconds after angioplastieballoninflation ] [ Designated as safety issue: No ]

    Immediately after the preconditioning Cycle the PCI ballon will be positioned in the coronary artery lesion and inflated for 2 minutes followed by 5 minutes of reperfusion. This cycle will be repeated for 3 times without any interruption. Intracoronary ECGs and 12 lead surface ecgs will be taken immediately before and at the end of each ballon inflation (two minutes after beginning the intracoronary ballon inflation). after taking the ecgs the ballon will be deflated.

    The st-deviations will be analysed.



Secondary Outcome Measures:
  • troponin I [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]
    Troponin levels will be evaluated 24 h after PCI

  • chest pain (Maximum) [ Time Frame: timeperiod 2 minutes ] [ Designated as safety issue: No ]
    the maximal chest pain occuring during each of the Pci balloninflations will be documented as a number out of 10. 0 is determined as no pain and 10 is determined as the heaviest pain which the patient ever experienced. A specific timepoint has not been defined.


Biospecimen Retention:   Samples Without DNA

venous blood samples (10 ml) will be taken from the femoral vein of the preconditioned leg immediately before and after the preconditioning cycles.

Also arterial blood samples (10 ml)will be taken immediately before and after the preconditioning cycle.


Enrollment: 30
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
control group
A Blood pressure cuff and and the musclestimulator pads will be applyed 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 angioplastie.
intervention group 1
A Blood pressure cuff and and the musclestimulator pads will be applyed 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 repeted for 3 times. Therewill be no electrical muscle stimulation in this group.
Device: blood pressure cuff

A Blood pressure cuff and and the musclestimulator pads will be applyed 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 repeted for 3 times.

Device: WelchAllyn, USA; Flexiport Reusable Bloodpressure Cuff 12L

intervention group 2
A Blood pressure cuff and the musclestimulator pads will be applyed 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 repeted for 3 times. In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle
Device: blood pressure cuff + electric musclestimulator

A Blood pressure cuff and and the musclestimulator pads will be applyed 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 repeted for 3 times. In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle.

Device 1: bloodpressure cuff (WelchAllyn, USA; Flexiport Reusable Bloodpressure Cuff 12L) Device 2: musclestimulator (gbo, Germany; HiToP 191)


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 limbischemia 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 angioplastyballooninflation in an intracoronary (derived by PCI wire) and surface ecg.

Also the maximum of chestpain during the 3 inflationcycles and troponinlevels 24 h after PCI will be evaluated.

Evaluation of patientoutcome is not planned.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing elective PCI fulfilling the inclusion and exclusion criteria.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of collateral vessels (according to rentrop criterias)
  • electrocardiographic bundle branch blocks
  • multiple coronory 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, Morphin und Derivates, Immunosuppressive agents, oral antibiotics, Theophyllin, alpha Receptor blockers)
  • peripheral arterial disease
  • exercise tests performed within 24 h before study start.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357499

Locations
Germany
Ernst Moritz Arndt Universität Greifswald
Greifswald, MVP, Germany, 17489
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Principal Investigator: Markus Reinthaler, MD Ernst Moritz Arndt University Greifswald
Principal Investigator: Thorsten Reffelmann, MD Ernst Moritz Arndt University Greifswald
  More Information

No publications provided

Responsible Party: Markus Reinthaler, MD, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT01357499     History of Changes
Other Study ID Numbers: 1-reinthaler
Study First Received: May 10, 2011
Last Updated: June 29, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014