Status:
WITHDRAWN
Cardioprotective Effect of RIPC in Patients Undergoing TAVI
Lead Sponsor:
Institut für Pharmakologie und Präventive Medizin
Conditions:
Effectivity of RIPC in Outcomes of TAVI Procedure
Eligibility:
All Genders
Phase:
NA
Brief Summary
We aim to investigate whether RIPC (remote ischemic preconditioning) is effective in the TAVI setting to reduce post-procedural myocardial damage and improve patient outcome. Accordingly, we aim to in...
Detailed Description
Transcatheter aortic valve implantation (TAVI) is associated to myocardial injury, defined as post-procedural cardiac troponin (cTn) elevation. Earlier experiences have shown that myocardial damage ca...
Eligibility Criteria
Inclusion
- Indication for elective TAVI following Heart Team discussion
- Stable hemodynamic conditions without circulatory support or catecholamines
Exclusion
- Myocardial infarction at least 3 months before enrollment
- Stroke/TIA at least 3 months before enrollment
- Severe chronic kidney disease (defined as a baseline serum creatinine of \> 1.5 mg/dl or an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m2 )
- PCI at least 3 months before enrollment
- Abnormal (\>99th percentile of laboratory cut-off) baseline values of biomarkers of myocardial ischemia (i.e. TnT, CK-MB)
- Abnormal NSE values at baseline (local laboratory cut-off values)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02283398
Start Date
November 1 2014
End Date
April 1 2016
Last Update
September 28 2015
Active Locations (3)
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1
Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie
Dortmund, Germany, 44137
2
Evangelisches Klinikum Niederrhein, Kardiologie
Duisburg, Germany, 47169
3
Klinikum Karlsruhe
Karlsruhe, Germany, 76133