Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
NCT ID: NCT02080299
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2013-09-30
2017-08-31
Brief Summary
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Detailed Description
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* After induction of conscious sedation or general anaesthesia, RIPC is accomplished by 3 cycles of 5 min inflation/5 min deflation of a blood pressure cuff around the left arm to 200 mm Hg. In the placebo group, the blood pressure cuff remains uninflated for 30 min.
* Blind: study coordinators, outcome assessors, operators and treating physicians except for the attending anaesthetist.
* Drugs used for conscious sedation: midazolam, remifentanil.
* Drugs used for general anaesthesia: sufentanil, etomidate, rocuronium, isoflurane.
* TAVI is performed by standard techniques using the balloon-expandable Sapien XT (Edwards Lifesciences Inc., Irvine, California, USA) and the next-generation Sapien 3 stent-valve bioprosthesis which replaces the Sapien XT prosthesis, when CE-approved.
* Arterial blood samples are obtained prior to and after RIPC-maneuver/Placebo, after aortic valve implantation and after access site closure, for biochemical analyses focussing on ligands that have been previously implicated in conditioning protocols at various organs. A bioassay system, consisting of a Langendorff-perfused isolated heart with ischemia and reperfusion will be used. This bioassay system will be exposed to the obtained arterial plasma of the patients.
* Venous blood samples are drawn before TAVI and at 1, 6, 12, 24, 48 and 72 hours after the procedure.
* Cardiac and cerebral MRI is performed in selected patients at baseline and within the first week after TAVI.
* On-site follow-up at 3±3 months, 12±3 months and yearly thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Remote ischemic preconditioning (RIPC)
RIPC-protocol before TAVI: after induction of conscious sedation/anesthesia, but prior to TAVI procedure, remote ischemic preconditioning (RIPC) protocol is performed, consisting of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion, followed by a time interval between the end of the last deflation and local groin anaesthesia with subsequent skin puncture of 30 min.
Remote ischemic preconditioning (RIPC)
3 circles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion, preceding TAVI procedure.
Placebo
Placebo protocol before TAVI: After induction of conscious sedation/anesthesia and before TAVI, the cuff is left uninflated for 30 min, followed by a further time interval of 30 min until local groin anaesthesia with subsequent skin puncture.
Placebo
Prior to TAVI-procedure, the blood pressure cuff remains uninflated for 30 min.
Interventions
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Remote ischemic preconditioning (RIPC)
3 circles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion, preceding TAVI procedure.
Placebo
Prior to TAVI-procedure, the blood pressure cuff remains uninflated for 30 min.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Patients who are unlikely to gain improvement in their quality of life by TAVI procedure
* Unfavorable anatomy for TAVI (e.g. inadequate annulus size)
* Left-ventricular thrombus
* Active endocarditis
* Active infection
* Acute ST-segment elevation myocardial infarction
* Hemodynamic instability
* Preoperative troponin I concentration above the upper normal limit of 0.1 ng/ml
* Stroke within the last 6 weeks
* Acute or chronic hemodialysis
18 Years
ALL
No
Sponsors
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Koblenz University of Applied Science
OTHER
University Hospital, Essen
OTHER
Responsible Party
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Philipp Kahlert
MD
Principal Investigators
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Philipp Kahlert, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen
Matthias Thielmann, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen
Petra Kleinbongard, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Pathophysiology, University Duisburg-Essen
Eva Kottenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for Anesthesiology and Intensive Care Medicine, University Duisburg-Essen
Jürgen Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for Anesthesiology and Intensive Care Medicine, University Duisburg-Essen
Heinz Jakob, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen
Raimund Erbel, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen
Gerd Heusch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Pathophysiology, University Duisburg-Essen
Locations
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Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen
Essen, , Germany
Countries
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References
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Thielmann M, Kottenberg E, Boengler K, Raffelsieper C, Neuhaeuser M, Peters J, Jakob H, Heusch G. Remote ischemic preconditioning reduces myocardial injury after coronary artery bypass surgery with crystalloid cardioplegic arrest. Basic Res Cardiol. 2010 Sep;105(5):657-64. doi: 10.1007/s00395-010-0104-5. Epub 2010 May 21.
Kottenberg E, Thielmann M, Bergmann L, Heine T, Jakob H, Heusch G, Peters J. Protection by remote ischemic preconditioning during coronary artery bypass graft surgery with isoflurane but not propofol - a clinical trial. Acta Anaesthesiol Scand. 2012 Jan;56(1):30-8. doi: 10.1111/j.1399-6576.2011.02585.x. Epub 2011 Nov 21.
Heusch G, Musiolik J, Kottenberg E, Peters J, Jakob H, Thielmann M. STAT5 activation and cardioprotection by remote ischemic preconditioning in humans: short communication. Circ Res. 2012 Jan 6;110(1):111-5. doi: 10.1161/CIRCRESAHA.111.259556. Epub 2011 Nov 23.
Kottenberg E, Musiolik J, Thielmann M, Jakob H, Peters J, Heusch G. Interference of propofol with signal transducer and activator of transcription 5 activation and cardioprotection by remote ischemic preconditioning during coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2014 Jan;147(1):376-82. doi: 10.1016/j.jtcvs.2013.01.005. Epub 2013 Mar 1.
Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhauser M, Peters J, Jakob H, Heusch G. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet. 2013 Aug 17;382(9892):597-604. doi: 10.1016/S0140-6736(13)61450-6.
Kleinbongard P, Thielmann M, Jakob H, Peters J, Heusch G, Kottenberg E. Nitroglycerin does not interfere with protection by remote ischemic preconditioning in patients with surgical coronary revascularization under isoflurane anesthesia. Cardiovasc Drugs Ther. 2013 Aug;27(4):359-61. doi: 10.1007/s10557-013-6451-3. No abstract available.
Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, Johansson U, Wendt D, Jakob HG, Forsting M, Sack S, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010 Feb 23;121(7):870-8. doi: 10.1161/CIRCULATIONAHA.109.855866.
Kahlert P, Hildebrandt HA, Patsalis PC, Al-Rashid F, Janosi RA, Nensa F, Schlosser TW, Schlamann M, Wendt D, Thielmann M, Kottenberg E, Frey U, Neuhauser M, Forsting M, Jakob HG, Rassaf T, Peters J, Heusch G, Kleinbongard P. No protection of heart, kidneys and brain by remote ischemic preconditioning before transfemoral transcatheter aortic valve implantation: Interim-analysis of a randomized single-blinded, placebo-controlled, single-center trial. Int J Cardiol. 2017 Mar 15;231:248-254. doi: 10.1016/j.ijcard.2016.12.005. Epub 2016 Dec 6.
Other Identifiers
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135355-BO
Identifier Type: -
Identifier Source: org_study_id