Cardioprotective Effect of RIPC in Patients Undergoing TAVI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation

NCT02080299

Aortic Valve Stenosis

UNKNOWN PHASE2

Remote Ischemic Preconditioning in Aortic Valve Surgery

NCT01390129

Aortic Valve Stenosis

COMPLETED NA

Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

NCT04437303

Aortic Valve Disease Aortic Valve Stenosis Stroke +4 more

COMPLETED PHASE4

Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI

NCT03001960

Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Intracranial Embolism

UNKNOWN PHASE3

Acute STROke Complicating TAVI - Management and Outcomes

NCT05241821

Stroke Aortic Valve Stenosis Periprocedural Complication

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Effectivity of RIPC in Outcomes of TAVI Procedure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

RIPC

Intervention Type 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

without RIPC

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

Group Type SHAM_COMPARATOR

without RIPC

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

without RIPC

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

Intervention Type OTHER

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

no remote ischemic preconditioning remote ischemic preconditioning

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No