Cardioprotective Effect of RIPC in Patients Undergoing TAVI

NCT02283398 | Withdrawn

• 1 other identifier: CARE-TAVI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Effectivity of RIPC in Outcomes of TAVI Procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Post-procedural myocardial injury

  72 hours after intervention

• Post-procedural acute kidney injury

  72 hours after intervention

• Post-procedural brain injury

  72 hours after intervention

• composite of major adverse cardiac and cerebrovascular events

  discharge, at 30 days and at 1 year

Study Arms (2)

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

Procedure: RIPC

without RIPC

SHAM COMPARATOR

the cuff will be placed around the left arm without being inflated

Other: without RIPC

Interventions

without RIPC OTHER

the cuff will be placed around the left arm without being inflated

Also known as: no remote ischemic preconditioning

without RIPC

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

Also known as: remote ischemic preconditioning

with RIPC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (3)

Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie

Dortmund, 44137, Germany

Location

Evangelisches Klinikum Niederrhein, Kardiologie

Duisburg, 47169, Germany

Location

Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Study Officials

• Christoph Naber, PD Dr. med.

  Elisabeth-Krankenhaus Essen, Klinik für Kardiologie und Angiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

DE (3)