Carotid StenosisRIP-CEANCT02808754
Remote Ischemic Preconditioning for Carotid Endarterectomy
A study testing Remote Ischemic Preconditioning in people with Carotid Stenosis and Endarterectomy, Carotid, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA) for carotid artery stenosis (CAS). The outcomes of interest include neurocognitive function, cardiac complications, and biomarkers of brain ischemia. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Carotid Stenosis, Endarterectomy, Carotid
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jan 2019
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing carotid endarterectomy
- Indication for surgery must be symptomatic disease with >50% stenosis by duplex ultrasound or asymptomatic disease with >60% stenosis by duplex ultrasound
Who cannot join
- Lack of radial pulse on either arm
- Known Deep venous thrombosis (DVT) in arm
- Arteriovenous fistula or graft in both arms
- Diagnosed hypercoagulable state
- Pre-existing lymphedema or axillary node dissection both arms
- Diagnosis of dementia, intellectual disability, or mental illness including depression, anxiety, or schizophrenia
- Simultaneous coronary artery bypass grafting
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA) for carotid artery stenosis (CAS). The outcomes of interest include neurocognitive function, cardiac complications, and biomarkers of brain ischemia.
Read the detailed description
Multiple large, high quality randomized trials have shown carotid endarterectomy (CEA) is effective in decreasing future risk of stroke in patients with carotid artery stenosis. Outcomes after carotid endarterectomy have improved over time. The major risks including stroke and myocardial infarction (MI) are rare (<3% stroke and 4% for MI. However, subtle degrees of cerebral ischemia and myocardial injury are more common. Research is now focused finding ways to reduce these subclinical adverse effects of CEA.
Due to its high metabolic activity, the brain is especially vulnerable to periods of ischemia during carotid cross clamping. Ischemic tolerance has been demonstrated after direct ischemic conditioning in the brain. However, direct conditioning is difficult and potentially dangerous when is comes to carotid interventions making remote ischemic preconditioning an attractive alternative. In animal models, remote ischemic preconditioning (RIPC) has been shown to produce an equivalent response to direct neuronal conditioning at the cellular level.
The precise mechanisms underlying the phenomenon of RIPC have yet to be fully elucidated. However, It is likely that both neural and humoral mechanisms are at play. Multiple studies have shown decreased levels of inflammatory markers in brains of animal models undergoing RIPC and then middle cerebral artery occlusion.
There has only been one study of RIPC in carotid endarterectomy so far. Patients were randomized to 10 min ischemia on each leg prior to clamping the carotid. Primary outcome was significant postoperative deterioration in saccadic latency determined by quantitative oculometry (time taken to respond and fix on a visual stimulus that appears suddenly). Additionally, troponins were drawn up to 48 hours post operatively. There was deterioration in quantitative oculometry in 8/25 RIPC and 16/30 control (p=0.11) and no difference in troponins. However this was a small number of patients.
Major clinical events such as stroke or MI are uncommon following CEA. This hampers the assessment of new, novel interventions as any trial would require several thousand patients to detect a useful clinical effect. The only alternative is to use surrogate end points to obtain "proof of concept" justifying larger trials. Several serum markers of neuronal damage such as S100-beta and neuron-specific enolase have been identified but are not reliable or specific enough to be used clinically. Another surrogate that is directly related to the concept of subtle degrees of neuronal ischemia occurring during CEA is neurocognitive function.
20-25% of patients have been shown to experience significant cognitive decline following CEA. This has been correlated with findings of ischemia on diffusion weighted MRI in patients after CEA indicating that local ischemia and microemboli are responsible for this decline. Thus, neurocognitive testing before and after carotid revascularization may be an ideal surrogate end point to study in remote ischemic preconditioning and it's potential to mediate the subtle degree of neuronal ischemia produced during carotid revascularization. However, neurocognitive function is also an endpoint with clinical relevance to patients.
This study will be a double armed randomized trial. The treatment arm will be Remote ischemic preconditioning and the Control arm will be Usual care. Intervention allocation ratio will be 1:1 RIPC:usual care. Randomization strategy will be a using a 1:1 fixed block of 4 randomization stratified by symptom status and age. Those randomized to RIPC will undergo a standard protocol of 4 cycles of 5 minutes of forearm ischemia with 5 minutes of reperfusion requiring 35 minutes for an application. Forearm ischemia will be induced by a blood pressure cuff inflated to 200 millimeters of mercury (mmHg) or at least 15mmHg higher than the systolic pressure if systolic > 185mmHg or until the radial pulse is obliterated. This can occur during anesthesia induction and incision/dissection prior to manipulation or clamping of the carotid.
- Conditions
- Carotid Stenosis, Endarterectomy, Carotid
- Being tested
- Remote Ischemic Preconditioning
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
Those randomized to RIPC will undergo a standard protocol of 4 cycles of 5 minutes of forearm ischemia with 5 minutes of reperfusion requiring 35 minutes for an application. Forearm ischemia will be induced by a blood pressure cuff inflated to 200mmHg or at least 15mmHg higher than the systolic pressure if systolic > 185mmHg or until the radial pulse is obliterated. This can occur during anesthesia induction and incision/dissection prior to manipulation or clamping of the carotid.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients in the usual care arm will undergo CEA without RIPC. |
| Remote Ischemic Preconditioning | Experimental | Patients in the RIPC arm will undergo CEA with RIPC. Receives: Procedure: Remote Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in Neurocognitive function
Montreal cognitive assessment
Measured: 1 month before surgery and post operative day 1
Longterm change in Neurocognitive function
Montreal cognitive assessment
Measured: 1 month before surgery and 1 month post operatively
Secondary outcomes (6)
S100-beta biomarker
serum level of S100-beta
Measured: Post operative day one
Troponin
serum troponin level
Measured: post operative day one
Stroke
Stroke diagnosed by MRI findings of new stroke (obtained if symptomatic)
Measured: within 30 days post operative
Neuron specific enolase (NSE) biomarker
Serum level of NSE
Measured: Post operative day one
Adverse cardiac events
Any new myocardial infarction, new arrhythmia, or new onset heart failure
Measured: 30 days postoperative
Severity of stroke
National Institute of Health Stroke Scale
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Domenick Sridharan, University of Pittsburgh
- Investigators
- Natalie Sridharan, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808754
- Sponsor's protocol ID
- PRO16030479
- Other IDs
- UL1TR001857
- Acronym
- RIP-CEA
- Status last verified
- Feb 2019
- First submitted
- 16 Jun 2016
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists' Collaboration. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet. 2003 Jan 11;361(9352):107-16. doi: 10.1016/s0140-6736(03)12228-3.
PubMed 12531577LaMuraglia GM, Brewster DC, Moncure AC, Dorer DJ, Stoner MC, Trehan SK, Drummond EC, Abbott WM, Cambria RP. Carotid endarterectomy at the millennium: what interventional therapy must match. Ann Surg. 2004 Sep;240(3):535-44; discussion 544-6. doi: 10.1097/01.sla.0000137142.26925.3c.
PubMed 15319725Kragsterman B, Parsson H, Lindback J, Bergqvist D, Bjorck M; Swedish Vascular Registry (Swedvasc). Outcomes of carotid endarterectomy for asymptomatic stenosis in Sweden are improving: Results from a population-based registry. J Vasc Surg. 2006 Jul;44(1):79-85. doi: 10.1016/j.jvs.2006.03.003. Epub 2006 May 6.
PubMed 16682166Dellagrammaticas D, Lewis S, Colam B, Rothwell PM, Warlow CP, Gough MJ; GALA trial collaborators. Carotid endarterectomy in the UK: acceptable risks but unacceptable delays. Clin Med (Lond). 2007 Dec;7(6):589-92. doi: 10.7861/clinmedicine.7-6-589.
PubMed 18193707Inoue T, Ohwaki K, Tamura A, Tsutsumi K, Saito I, Saito N. Subclinical ischemia verified by somatosensory evoked potential amplitude reduction during carotid endarterectomy: negative effects on cognitive performance. J Neurosurg. 2013 May;118(5):1023-9. doi: 10.3171/2013.1.JNS121668. Epub 2013 Mar 1.
PubMed 23451902Faries PL, DeRubertis B, Trocciola S, Karwowski J, Kent KC, Chaer RA. Ischemic preconditioning during the use of the PercuSurge occlusion balloon for carotid angioplasty and stenting. Vascular. 2008 Jan-Feb;16(1):1-9. doi: 10.2310/6670.2008.00012.
PubMed 18258156Steiger HJ, Hanggi D. Ischaemic preconditioning of the brain, mechanisms and applications. Acta Neurochir (Wien). 2007 Jan;149(1):1-10. doi: 10.1007/s00701-006-1057-1. Epub 2006 Dec 14.
PubMed 17151832Vlasov TD, Korzhevskii DE, Polyakova EA. Ischemic preconditioning of the rat brain as a method of endothelial protection from ischemic/repercussion injury. Neurosci Behav Physiol. 2005 Jul;35(6):567-72. doi: 10.1007/s11055-005-0095-0.
PubMed 16342612Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
PubMed 18456674Gonzalez NR, Connolly M, Dusick JR, Bhakta H, Vespa P. Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage. Neurosurgery. 2014 Nov;75(5):590-8; discussion 598. doi: 10.1227/NEU.0000000000000514.
PubMed 25072112Walsh SR, Tang TY, Kullar P, Jenkins DP, Dutka DP, Gaunt ME. Ischaemic preconditioning during cardiac surgery: systematic review and meta-analysis of perioperative outcomes in randomised clinical trials. Eur J Cardiothorac Surg. 2008 Nov;34(5):985-94. doi: 10.1016/j.ejcts.2008.07.062. Epub 2008 Sep 9.
PubMed 18783958Healy DA, Clarke Moloney M, McHugh SM, Grace PA, Walsh SR. Remote ischaemic preconditioning as a method for perioperative cardioprotection: concepts, applications and future directions. Int J Surg. 2014 Oct;12(10):1093-9. doi: 10.1016/j.ijsu.2014.08.352. Epub 2014 Aug 21.
PubMed 25152442Le Page S, Bejan-Angoulvant T, Angoulvant D, Prunier F. Remote ischemic conditioning and cardioprotection: a systematic review and meta-analysis of randomized clinical trials. Basic Res Cardiol. 2015 Mar;110(2):11. doi: 10.1007/s00395-015-0467-8. Epub 2015 Feb 5.
PubMed 25653117Walsh SR, Nouraei SA, Tang TY, Sadat U, Carpenter RH, Gaunt ME. Remote ischemic preconditioning for cerebral and cardiac protection during carotid endarterectomy: results from a pilot randomized clinical trial. Vasc Endovascular Surg. 2010 Aug;44(6):434-9. doi: 10.1177/1538574410369709. Epub 2010 May 18.
PubMed 20484064Sahlein DH, Heyer EJ, Rampersad A, Winfree CJ, Solomon RA, Benvenisty AI, Quest DO, Du E, Connolly ES. Failure of intraoperative jugular bulb S-100B and neuron-specific enolase sampling to predict cognitive injury after carotid endarterectomy. Neurosurgery. 2003 Dec;53(6):1243-9 discussion 1249-50. doi: 10.1227/01.neu.0000093493.16850.11.
PubMed 14633290
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning for Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT02808754
- Acronym / sponsor ID
- RIP-CEA / PRO16030479
- Conditions
- Carotid Stenosis, Endarterectomy, Carotid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Jun 2016 (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.
This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA) for carotid artery stenosis (CAS). The outcomes of interest include neurocognitive function, cardiac complications, and biomarkers of brain ischemia.
Detailed description
Multiple large, high quality randomized trials have shown carotid endarterectomy (CEA) is effective in decreasing future risk of stroke in patients with carotid artery stenosis. Outcomes after carotid endarterectomy have improved over time. The major risks including stroke and myocardial infarction (MI) are rare (<3% stroke and 4% for MI. However, subtle degrees of cerebral ischemia and myocardial injury are more common. Research is now focused finding ways to reduce these subclinical adverse effects of CEA.
Due to its high metabolic activity, the brain is especially vulnerable to periods of ischemia during carotid cross clamping. Ischemic tolerance has been demonstrated after direct ischemic conditioning in the brain. However, direct conditioning is difficult and potentially dangerous when is comes to carotid interventions making remote ischemic preconditioning an attractive alternative. In animal models, remote ischemic preconditioning (RIPC) has been shown to produce an equivalent response to direct neuronal conditioning at the cellular level.
The precise mechanisms underlying the phenomenon of RIPC have yet to be fully elucidated. However, It is likely that both neural and humoral mechanisms are at play. Multiple studies have shown decreased levels of inflammatory markers in brains of animal models undergoing RIPC and then middle cerebral artery occlusion.
There has only been one study of RIPC in carotid endarterectomy so far. Patients were randomized to 10 min ischemia on each leg prior to clamping the carotid. Primary outcome was significant postoperative deterioration in saccadic latency determined by quantitative oculometry (time taken to respond and fix on a visual stimulus that appears suddenly). Additionally, troponins were drawn up to 48 hours post operatively. There was deterioration in quantitative oculometry in 8/25 RIPC and 16/30 control (p=0.11) and no difference in troponins. However this was a small number of patients.
Major clinical events such as stroke or MI are uncommon following CEA. This hampers the assessment of new, novel interventions as any trial would require several thousand patients to detect a useful clinical effect. The only alternative is to use surrogate end points to obtain "proof of concept" justifying larger trials. Several serum markers of neuronal damage such as S100-beta and neuron-specific enolase have been identified but are not reliable or specific enough to be used clinically. Another surrogate that is directly related to the concept of subtle degrees of neuronal ischemia occurring during CEA is neurocognitive function.
20-25% of patients have been shown to experience significant cognitive decline following CEA. This has been correlated with findings of ischemia on diffusion weighted MRI in patients after CEA indicating that local ischemia and microemboli are responsible for this decline. Thus, neurocognitive testing before and after carotid revascularization may be an ideal surrogate end point to study in remote ischemic preconditioning and it's potential to mediate the subtle degree of neuronal ischemia produced during carotid revascularization. However, neurocognitive function is also an endpoint with clinical relevance to patients.
This study will be a double armed randomized trial. The treatment arm will be Remote ischemic preconditioning and the Control arm will be Usual care. Intervention allocation ratio will be 1:1 RIPC:usual care. Randomization strategy will be a using a 1:1 fixed block of 4 randomization stratified by symptom status and age. Those randomized to RIPC will undergo a standard protocol of 4 cycles of 5 minutes of forearm ischemia with 5 minutes of reperfusion requiring 35 minutes for an application. Forearm ischemia will be induced by a blood pressure cuff inflated to 200 millimeters of mercury (mmHg) or at least 15mmHg higher than the systolic pressure if systolic > 185mmHg or until the radial pulse is obliterated. This can occur during anesthesia induction and incision/dissection prior to manipulation or clamping of the carotid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients in the usual care arm will undergo CEA without RIPC. |
| Remote Ischemic Preconditioning | Experimental | Procedure: Remote Ischemic PreconditioningPatients in the RIPC arm will undergo CEA with RIPC. |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing carotid endarterectomy
- Indication for surgery must be symptomatic disease with >50% stenosis by duplex ultrasound or asymptomatic disease with >60% stenosis by duplex ultrasound
Key exclusion criteria (7 listed)
- Lack of radial pulse on either arm
- Known Deep venous thrombosis (DVT) in arm
- Arteriovenous fistula or graft in both arms
- Diagnosed hypercoagulable state
- Pre-existing lymphedema or axillary node dissection both arms
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 |
|---|---|---|
| Remote Ischemic PreconditioningThose randomized to RIPC will undergo a standard protocol of 4 cycles of 5 minutes of forearm ischemia with 5 minutes of reperfusion requiring 35 minutes for an application. Forearm ischemia will be induced by a blood pressure cuff inflated to 200mmHg or at least 15mmHg higher than the systolic pressure if systolic > 185mmHg or until the radial pulse is obliterated. This can occur during anesthesia induction and incision/dissection prior to manipulation or clamping of the carotid. | Procedure or surgery | Remote Ischemic Preconditioning |
Primary outcome
Immediate change in Neurocognitive function
Time frame: 1 month before surgery and post operative day 1
Montreal cognitive assessment
Longterm change in Neurocognitive function
Time frame: 1 month before surgery and 1 month post operatively
Montreal cognitive assessment
6 secondary outcomes
S100-beta biomarker
Time frame: Post operative day one
Troponin
Time frame: post operative day one
Stroke
Time frame: within 30 days post operative
Neuron specific enolase (NSE) biomarker
Time frame: Post operative day one
Adverse cardiac events
Time frame: 30 days postoperative
Severity of stroke
Time frame: 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Background: PubMed 12531577Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists' Collaboration. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet. 2003 Jan 11;361(9352):107-16. doi: 10.1016/s0140-6736(03)12228-3.
- Background: PubMed 15319725LaMuraglia GM, Brewster DC, Moncure AC, Dorer DJ, Stoner MC, Trehan SK, Drummond EC, Abbott WM, Cambria RP. Carotid endarterectomy at the millennium: what interventional therapy must match. Ann Surg. 2004 Sep;240(3):535-44; discussion 544-6. doi: 10.1097/01.sla.0000137142.26925.3c.
- Background: PubMed 16682166Kragsterman B, Parsson H, Lindback J, Bergqvist D, Bjorck M; Swedish Vascular Registry (Swedvasc). Outcomes of carotid endarterectomy for asymptomatic stenosis in Sweden are improving: Results from a population-based registry. J Vasc Surg. 2006 Jul;44(1):79-85. doi: 10.1016/j.jvs.2006.03.003. Epub 2006 May 6.
- Background: PubMed 18193707Dellagrammaticas D, Lewis S, Colam B, Rothwell PM, Warlow CP, Gough MJ; GALA trial collaborators. Carotid endarterectomy in the UK: acceptable risks but unacceptable delays. Clin Med (Lond). 2007 Dec;7(6):589-92. doi: 10.7861/clinmedicine.7-6-589.
- Background: PubMed 23451902Inoue T, Ohwaki K, Tamura A, Tsutsumi K, Saito I, Saito N. Subclinical ischemia verified by somatosensory evoked potential amplitude reduction during carotid endarterectomy: negative effects on cognitive performance. J Neurosurg. 2013 May;118(5):1023-9. doi: 10.3171/2013.1.JNS121668. Epub 2013 Mar 1.
- Background: PubMed 18258156Faries PL, DeRubertis B, Trocciola S, Karwowski J, Kent KC, Chaer RA. Ischemic preconditioning during the use of the PercuSurge occlusion balloon for carotid angioplasty and stenting. Vascular. 2008 Jan-Feb;16(1):1-9. doi: 10.2310/6670.2008.00012.
- Background: PubMed 17151832Steiger HJ, Hanggi D. Ischaemic preconditioning of the brain, mechanisms and applications. Acta Neurochir (Wien). 2007 Jan;149(1):1-10. doi: 10.1007/s00701-006-1057-1. Epub 2006 Dec 14.
- Background: PubMed 16342612Vlasov TD, Korzhevskii DE, Polyakova EA. Ischemic preconditioning of the rat brain as a method of endothelial protection from ischemic/repercussion injury. Neurosci Behav Physiol. 2005 Jul;35(6):567-72. doi: 10.1007/s11055-005-0095-0.
- Background: PubMed 18456674Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
- Background: PubMed 25072112Gonzalez NR, Connolly M, Dusick JR, Bhakta H, Vespa P. Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage. Neurosurgery. 2014 Nov;75(5):590-8; discussion 598. doi: 10.1227/NEU.0000000000000514.
- Background: PubMed 18783958Walsh SR, Tang TY, Kullar P, Jenkins DP, Dutka DP, Gaunt ME. Ischaemic preconditioning during cardiac surgery: systematic review and meta-analysis of perioperative outcomes in randomised clinical trials. Eur J Cardiothorac Surg. 2008 Nov;34(5):985-94. doi: 10.1016/j.ejcts.2008.07.062. Epub 2008 Sep 9.
- Background: PubMed 25152442Healy DA, Clarke Moloney M, McHugh SM, Grace PA, Walsh SR. Remote ischaemic preconditioning as a method for perioperative cardioprotection: concepts, applications and future directions. Int J Surg. 2014 Oct;12(10):1093-9. doi: 10.1016/j.ijsu.2014.08.352. Epub 2014 Aug 21.
- Individual participant dataSharing planned: No
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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.
Natalie Sridharan, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning in people with Carotid Stenosis and Endarterectomy, Carotid, run by University of Pittsburgh at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immediate change in Neurocognitive function (time frame: 1 month before surgery and post operative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02808754, which also lists 26 linked publications.
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 8 Feb 2019.