Effectivity of RIPC in Outcomes of TAVI ProcedureCARE-TAVINCT02283398
Cardioprotective Effect of RIPC in Patients Undergoing TAVI
A study testing without RIPC and RIPC in people with Effectivity of RIPC in Outcomes of TAVI Procedure, run by Institut für Pharmakologie und Präventive Medizin at 3 sites in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Effectivity of RIPC in Outcomes of TAVI Procedure
- What is being tested?
- without RIPC and RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indication for elective TAVI following Heart Team discussion
- Stable hemodynamic conditions without circulatory support or catecholamines
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinikum Dortmund, Medizinische Klinik Mitte - Kardiologie
Dortmund, 44137
Evangelisches Klinikum Niederrhein, Kardiologie
Duisburg, 47169
Klinikum Karlsruhe
Karlsruhe, 76133
About this study
Official title: 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.
Read the 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.
- Being tested
- without RIPC, RIPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without RIPCOther
Also called no remote ischemic preconditioning
the cuff will be placed around the left arm without being inflated
RIPCProcedure or surgery
Also called remote ischemic preconditioning
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: RIPC |
| without RIPC | Sham comparator | the cuff will be placed around the left arm without being inflated Receives: Other: without RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 72 hours after intervention
Secondary outcomes (4)
Post-procedural myocardial injury
defined by the geometric mean (95% CI) of the area under the curve (AUC) for CK-MB
Measured: 72 hours after intervention
Post-procedural acute kidney injury
defined according to the VARC 2 criteria
Measured: 72 hours after intervention
Post-procedural brain injury
defined by the geometric mean (95% CI) of the area under the curve (AUC) for NSE
Measured: 72 hours after intervention
composite of major adverse cardiac and cerebrovascular events
including death, postoperative myocardial infarction and cerebrovascular accident or stroke
Measured: discharge, at 30 days and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: administrative issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectivity of RIPC in Outcomes of TAVI ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Christoph Naber, PD Dr. med., Principal investigator, Elisabeth-Krankenhaus Essen, Klinik für Kardiologie und Angiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283398
- Sponsor's protocol ID
- CARE-TAVI
- Acronym
- CARE-TAVI
- Status last verified
- Sep 2015
- First submitted
- 3 Nov 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CARE-TAVI Study: Cardioprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT02283398
- Acronym / sponsor ID
- CARE-TAVI / CARE-TAVI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: administrative issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with RIPC | Experimental | Procedure: RIPCRIPC 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 | Sham comparator | Other: without RIPCthe cuff will be placed around the left arm without being inflated |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for elective TAVI following Heart Team discussion
- Stable hemodynamic conditions without circulatory support or catecholamines
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| without RIPCAlso: no remote ischemic preconditioningthe cuff will be placed around the left arm without being inflated | Other | without RIPC |
| RIPCAlso: remote ischemic preconditioningRIPC 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 or surgery | with RIPC |
Primary outcome
post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT
Time frame: 72 hours after intervention
Change in cardiac troponine T (cTnT)
4 secondary outcomes
Post-procedural myocardial injury
Time frame: 72 hours after intervention
Post-procedural acute kidney injury
Time frame: 72 hours after intervention
Post-procedural brain injury
Time frame: 72 hours after intervention
composite of major adverse cardiac and cerebrovascular events
Time frame: discharge, at 30 days and at 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Naber, PD Dr. med. principal investigator
Elisabeth-Krankenhaus Essen, Klinik für Kardiologie und Angiologie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing without RIPC and RIPC in people with Effectivity of RIPC in Outcomes of TAVI Procedure, run by Institut für Pharmakologie und Präventive Medizin at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-procedural myocardial injury, defined by the geometric mean (95% CI) of the area under the curve (AUC) for cTnT (time frame: 72 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.