Not provided
Not provided
Not provided
Not provided
administrative issues
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with RIPC | Experimental | RIPC will be induced with three cycles of inflation of a blood-pressure cuff on the left arm to 200 mm Hg for 5 min, followed by 5 min of reperfusion while cuff deflated |
|
| without RIPC | Sham Comparator | the cuff will be placed around the left arm without being inflated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| without RIPC | Other | the cuff will be placed around the left arm without being inflated |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT | Change in cardiac troponine T (cTnT) | 72 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedural myocardial injury | defined by the geometric mean (95% CI) of the area under the curve (AUC) for CK-MB | 72 hours after intervention |
| Post-procedural acute kidney injury | defined according to the VARC 2 criteria |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christoph Naber, PD Dr. med. | Elisabeth-Krankenhaus Essen, Klinik für Kardiologie und Angiologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie | Dortmund | 44137 | Germany | |||
| Evangelisches Klinikum Niederrhein, Kardiologie |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RIPC | Procedure | RIPC will be induced with three cycles of inflation of a blood-pressure cuff on the left arm to 200 mm Hg for 5 min, followed by 5 min of reperfusion while cuff deflated |
|
|
| 72 hours after intervention |
| Post-procedural brain injury | defined by the geometric mean (95% CI) of the area under the curve (AUC) for NSE | 72 hours after intervention |
| composite of major adverse cardiac and cerebrovascular events | including death, postoperative myocardial infarction and cerebrovascular accident or stroke | discharge, at 30 days and at 1 year |
| Duisburg |
| 47169 |
| Germany |
| Klinikum Karlsruhe | Karlsruhe | 76133 | Germany |