Cardioprotective Effect of RIPC in Patients Undergoing TAVI (CARE-TAVI)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Effectivity of RIPC in Outcomes of TAVI Procedure
• Intervention / Treatment: Procedure: RIPC; Other: without RIPC

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dortmund, Germany, 44137
    • Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie
  • Duisburg, Germany, 47169
    • Evangelisches Klinikum Niederrhein, Kardiologie
  • Karlsruhe, Germany, 76133
    • Klinikum Karlsruhe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with 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	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; Other Names: remote ischemic preconditioning
Sham Comparator: without RIPC; the cuff will be placed around the left arm without being inflated	Other: without RIPC; the cuff will be placed around the left arm without being inflated; Other Names: no remote ischemic preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Principal Investigator: Christoph Naber, PD Dr. med., Elisabeth-Krankenhaus Essen, Klinik für Kardiologie und Angiologie

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CARE-TAVI