Clinical trial NCT02283398: Cardioprotective Effect of RIPC in Patients Undergoing TAVI
Official title: The CARE-TAVI Study: Cardioprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Effectivity of RIPC in Outcomes of TAVI Procedure
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2014-11-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 investigate whether RIPC can be introduced as an integral part of the TAVI procedure, in order to reduce post-procedural myocardial damage and potentially improve patient outcome.

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 can be encountered in a percentage of patients that varies from 1.5% to 17%, depending on the access route (transfemoral and transapical, respectively). The degree of rise in cTn after TAVI emerged as an independent predictor of mortality.

Remote ischaemic preconditioning (RIPC) consists of brief episodes of ischaemia applied to remote organs or tissues and has shown to result in a significant reduction in postoperative troponin levels in cardiac and non-cardiac surgery patients. Lately, growing evidence suggests that post-procedural troponin decreases due to RIPC application protocols protocols and is associated with improved outcome.

The patients will be divided into two Groups. In Group 1, RIPS will be induced with three cycles of Inflation of a blood-pressure cuff on the left arm to 200 mmHg for 5 min., followed by 5 min. of reperfusion while the cuff is deflated. In controls (Group 2), the cuff will be placed around the left arm without being inflated.

Eligibility criteria: Inclusion Criteria:

* Indication for elective TAVI following Heart Team discussion
* Stable hemodynamic conditions without circulatory support or catecholamines

Exclusion Criteria:

* 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)

Primary outcomes:
measure: post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT
timeFrame: 72 hours after intervention
Secondary outcomes:
measure: Post-procedural myocardial injury
timeFrame: 72 hours after intervention
measure: Post-procedural acute kidney injury
timeFrame: 72 hours after intervention
measure: Post-procedural brain injury
timeFrame: 72 hours after intervention
measure: composite of major adverse cardiac and cerebrovascular events
timeFrame: discharge, at 30 days and at 1 year
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie
city: Duisburg
country: Germany
facility: Evangelisches Klinikum Niederrhein, Kardiologie
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe
Study officials:
affiliation: Elisabeth-Krankenhaus Essen, Klinik für Kardiologie und Angiologie
name: Christoph Naber, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: