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

15 november 2016 uppdaterad av: Marcus Doerr, University Medicine Greifswald

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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Tyskland
    • MVP
      • Greifswald, MVP, Tyskland, 17489
        • Ernst Moritz Arndt Universität Greifswald

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Patients undergoing elective PCI fulfilling the inclusion and exclusion criteria.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
control group
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
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.
Enhet: 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.
intervention group 2
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
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ST deviation
Tidsram: 120 seconds after angioplasty

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.
120 seconds after angioplasty

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
troponin I
Tidsram: 24 hours after PCI
Troponin levels will be evaluated 24 h after PCI
24 hours after PCI
chest pain (Maximum)
Tidsram: time period 2 minutes
the maximal chest pain occuring during each of the Pci balloon inflations 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.
time period 2 minutes

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Medicine Greifswald

Utredare

  • Huvudutredare: Markus Reinthaler, MD, Ernst Moritz Arndt University Greifswald
  • Huvudutredare: Thorsten Reffelmann, MD, Ernst Moritz Arndt University Greifswald

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2010

Primärt slutförande (Faktisk)

1 december 2013

Avslutad studie (Faktisk)

1 december 2013

Studieregistreringsdatum

Först inskickad

10 maj 2011

Först inskickad som uppfyllde QC-kriterierna

19 maj 2011

Första postat (Uppskatta)

20 maj 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 november 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 november 2016

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1-reinthaler

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