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| Name | Class |
|---|---|
| Koblenz University of Applied Science | OTHER |
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Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical practice, but concerns have been raised regarding periprocedural complications like e.g. myocardial injury, stroke or acute kidney injury. Remote ischemic preconditioning (RIPC) with upper limb ischemia/reperfusion provides perioperative myocardial protection in patients undergoing elective coronary artery bypass surgery. The present study assesses protection of heart, brain and kidney by RIPC in patients undergoing TAVI. The study also addresses safety and clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic preconditioning (RIPC) | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning (RIPC) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of periinterventional myocardial injury as reflected by the geometric mean of the area under the curve (AUC) for troponin I serum concentrations | 72 hours postinterventionally after TAVI |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural myocardial infarction according to current Valve Academic Research Consortium (VARC-2) criteria | 72 hours postinterventionally after TAVI | |
| Incidence of new wall abnormalities and deterioration of overall left ventricular function as assessed by postinterventional transthoracic echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Kahlert, MD | Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen | Principal Investigator |
| Matthias Thielmann, MD | Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen | Principal Investigator |
| Petra Kleinbongard, PhD | Institute of Pathophysiology, University Duisburg-Essen | Principal Investigator |
| Eva Kottenberg, MD | Clinic for Anesthesiology and Intensive Care Medicine, University Duisburg-Essen | Principal Investigator |
| Jürgen Peters, MD | Clinic for Anesthesiology and Intensive Care Medicine, University Duisburg-Essen | Principal Investigator |
| Heinz Jakob, MD | Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen | Principal Investigator |
| Raimund Erbel, MD | Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen | Principal Investigator |
| Gerd Heusch, MD, PhD | Institute of Pathophysiology, University Duisburg-Essen |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen | Essen | 45122 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20495811 | Background | 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. | |
| 22103808 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Procedure | Prior to TAVI-procedure, the blood pressure cuff remains uninflated for 30 min. |
|
| Within the first week after TAVI |
| Incidence of new-onset cardiac arrhythmias including the necessity of defibrillation or transient/permanent pacemaker implantation as assessed by continuous ECG-monitoring | Within the first week after TAVI |
| Prevalence and volume of delayed gadolinium enhancement | Cardiac MRI will be performed in selected patients. | Within the first week after TAVI |
| Maximum elevation of serum creatinine concentration | Until 72 hours after TAVI |
| Maximum decrease of estimated glomerular filtration rate | Until 72 hours after TAVI |
| Incidence of VARC-2 defined acute kidney injury | Until 72 hours after TAVI and until discharge |
| Total and median per patient number as well as total and median per patient volume of new foci of restricted diffusion | Cerebral MRI will be performed in selected patients. | Within the first week after TAVI |
| Cardioprotective factor release into circulating blood | Blood samples will be collected at 4 time points: prior to and after RIPC-maneuver/Placebo, after aortic valve implantation and after access site closure. Time frame: approximately 2,5 hours. | Day of intervention |
| All cause mortality and major adverse cardiac and cerebrovascular events (MACCE) at 30 days | Within the first 30 days after TAVI |
| All cause mortality and major adverse cardiac and cerebrovascular events (MACCE) at 1 year | Within the first year after TAVI |
| All cause mortality and major adverse cardiac and cerebrovascular events (MACCE) after 3 months | Until 3 months after TAVI |
| VARC-2 defined combined early TAVI safety endpoint at 30 days | Until 30 days after TAVI |
| 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. |
| 22116817 | Background | 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. |
| 23465551 | Background | 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. |
| 23953384 | Background | 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. |
| 23440355 | Background | 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. |
| 20177005 | Background | 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. |
| 27940009 | Derived | 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. |
| D014694 |
| Ventricular Outflow Obstruction |