Cardioprotective Effect of RIPC in Patients Undergoing TAVI

Effectivity of RIPC in Outcomes of TAVI Procedure Clinical Trial

— CARE-TAVI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02283398
• Other study ID #: CARE-TAVI
• Status: Withdrawn
• Phase: N/A
• First received: November 3, 2014
• Last updated: September 24, 2015
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Effectivity of RIPC in Outcomes of TAVI Procedure

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie	Dortmund
Germany	Evangelisches Klinikum Niederrhein, Kardiologie	Duisburg
Germany	Klinikum Karlsruhe	Karlsruhe

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Post-procedural acute kidney injury	defined according to the VARC 2 criteria	72 hours after intervention	No
Secondary	Post-procedural brain injury	defined by the geometric mean (95% CI) of the area under the curve (AUC) for NSE	72 hours after intervention	No
Secondary	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	No