Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous Coronary Intervention (PCI) (REMOTE)
Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Contacten en locaties
Studie Locaties
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MVP
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Greifswald, MVP, Duitsland, 17489
- Ernst Moritz Arndt Universität Greifswald
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
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|
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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.
|
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
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
ST deviation
Tijdsspanne: 120 seconds after angioplasty
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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troponin I
Tijdsspanne: 24 hours after PCI
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Troponin levels will be evaluated 24 h after PCI
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24 hours after PCI
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chest pain (Maximum)
Tijdsspanne: time period 2 minutes
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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.
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time period 2 minutes
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Markus Reinthaler, MD, Ernst Moritz Arndt University Greifswald
- Hoofdonderzoeker: Thorsten Reffelmann, MD, Ernst Moritz Arndt University Greifswald
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1-reinthaler
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