NCT02283398

Cardioprotective Effect of RIPC in Patients Undergoing TAVI

The CARE-TAVI Study: Cardioprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Transcatheter Aortic Valve Implantation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Effectivity of RIPC in Outcomes of TAVI Procedure

Interventions

Type	Name	Description
OTHER	without RIPC	the cuff will be placed around the left arm without being inflated
PROCEDURE	RIPC	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

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-11-05
• Last updated: 2015-09-28

Locations

3 sites across 1 country: Germany