<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01691911</url>
  </required_header>
  <id_info>
    <org_study_id>SAVES-123</org_study_id>
    <nct_id>NCT01691911</nct_id>
  </id_info>
  <brief_title>Preconditioning Shields Against Vascular Events in Surgery</brief_title>
  <acronym>SAVES</acronym>
  <official_title>Preconditioning Shields Against Vascular Events in Surgery. A Multi-Centre Trial of Preconditioning Against Adverse Events in Major Vascular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mid Western Regional Hospital, Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mid Western Regional Hospital, Ireland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Major vascular surgery involves operations to repair swollen blood vessels, clear debris from&#xD;
      blocked arteries or bypass blocked blood vessels. Patients with these problems are a&#xD;
      high-risk surgical group as they have generalized blood vessel disease. These puts them at&#xD;
      risk of major complications around the time of surgery such as heart attacks , strokes and&#xD;
      death. The mortality following repair of a swollen main artery in the abdomen is about 1 in&#xD;
      20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple&#xD;
      and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote&#xD;
      ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to&#xD;
      muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a&#xD;
      further five minutes. This cycle is repeated three more times. The blood supply is&#xD;
      interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated&#xD;
      brief interruption of the muscular blood supply sends signals to critical organs such as the&#xD;
      brain and heart, which are rendered temporarily resistant to damage from reduced blood&#xD;
      supply. Several small randomized clinical trials in patients undergoing different types of&#xD;
      major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial&#xD;
      aims to determine whether RIPC can reduce complications in routine practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The demand for major vascular surgery is increasing [1]. Patients requiring procedures such&#xD;
      as aortic aneurysm repair, carotid endarterectomy, lower limb surgical re-vascularisation and&#xD;
      major lower limb amputation for end-stage vascular disease constitute a high-risk surgical&#xD;
      cohort. Peri-operative complications such as myocardial infarction, cerebrovascular accident,&#xD;
      renal failure and death are common [2,3]. Multiple potential mechanisms may result in these&#xD;
      complications. For example, myocardial injury may result from systemic hypotension leading to&#xD;
      reduced flow across a tight coronary artery stenosis or, alternatively, it may arise due to&#xD;
      acute occlusion when an unstable plaque ruptures. Most strategies aimed at peri-operative&#xD;
      risk reduction target a single potential mechanism. For example, beta-blockade may prevent&#xD;
      myocardial injury due to overwork, but cannot prevent acute coronary occlusion. There is a&#xD;
      requirement for a simple, effective intervention that protects tissues against injury via&#xD;
      multiple different mechanisms. Remote ischemic preconditioning (RIPC) may be suitable.&#xD;
&#xD;
      Ischemic preconditioning is a phenomenon whereby a brief period of non-lethal ischemia in a&#xD;
      tissue renders it resistant to the effects of a subsequent much longer ischaemic insult. It&#xD;
      was first described in the canine heart [4]. Subsequent clinical trials showed that ischemic&#xD;
      preconditioning reduced heart muscle damage following coronary artery bypass grafting [5] and&#xD;
      liver dysfunction following hepatic resection [6]. Following cardiac surgery, it is&#xD;
      associated with a reduction in critical care stay, arrhythmias and inotrope use [7]. However,&#xD;
      ischemic preconditioning requires direct interference with the target tissues' blood supply,&#xD;
      limiting its clinical utility. Further experimental work suggested that brief ischemia in one&#xD;
      tissue, such as the kidneys, could confer protection on distant organs such as the heart [8].&#xD;
      A similar effect was observed after transient skeletal muscle ischemia [9-11]. This effect is&#xD;
      referred to as 'preconditioning at a distance' or 'remote ischemic preconditioning' (RIPC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major Adverse Clinical Events</measure>
    <time_frame>30 day</time_frame>
    <description>The primary endpoint for the trial will be Major Adverse Clinical Events. This is a composite endpoint comprising any of: cardiovascular death, myocardial infarction, new onset arrhythmia requiring treatment, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischaemia requiring intervention or biopsy proven ischaemic colitis, urgent cardiac revascularisation. All participants will undergo a serum troponin levels and 12-lead electrocardiogram on the second post-operative day to screen for silent peri-operative myocardial infarction. Trial ECGs and troponin levels will be interpreted by a blinded trial cardiologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of post-operative hospital stay</measure>
    <time_frame>30 day</time_frame>
    <description>The duration of hospital stay and ITU stay have a major impact on health service resource utilisation, and are factors which can be influenced by surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of intensive care unit stay</measure>
    <time_frame>30 day</time_frame>
    <description>The duration of hospital stay and ITU stay have a major impact on health service resource utilisation, and are factors which can be influenced by surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned critical care unit admission</measure>
    <time_frame>30 day</time_frame>
    <description>The duration of hospital stay and ITU stay have a major impact on health service resource utilisation, and are factors which can be influenced by surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury score in first three peri-operative days</measure>
    <time_frame>3 days</time_frame>
    <description>The Acute Kidney Injury Score will be calculated over the first three peri-operative days. Creatinine will be measured daily as part of routine care. Urine volumes will be calculated from the fluid balance charts maintained as part of usual care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-operative myocardial injury</measure>
    <time_frame>from operation to 72 hours postoperatively</time_frame>
    <description>Peri-operative myocardial injury will be assessed by measurement of serum troponin levels. This will be achieved by comparing area under the curve (AUC) for serum troponin concentration over the first three post-operative days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <condition>Carotid Atherosclerosis</condition>
  <condition>Critical Lower Limb Ischaemia</condition>
  <arm_group>
    <arm_group_label>Remote preconditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preconditioning will be performed in the same manner as several previous trials. Immediately after induction of anaesthesia, a standard, CE-approved blood pressure cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure &gt;185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles. In all other respects, the procedure and peri-operative care will follow the routine practices of the surgeons and anaesthetists involved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote preconditioning control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomised to this group will receive routine pre-operative, peri-operative and post operative care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote preconditioning</intervention_name>
    <description>Immediately after induction of anaesthesia, a standard, CE-approved tourniquet cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure &gt;185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles. In all other respects, the procedure and peri-operative care will follow the routine practices of the surgeons and anaesthetists involved.</description>
    <arm_group_label>Remote preconditioning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years&#xD;
&#xD;
          -  patient willing to give full informed consent for participation&#xD;
&#xD;
          -  Patients undergoing elective carotid endarterectomy or&#xD;
&#xD;
          -  Patients undergoing open abdominal aortic aneurysm repair or&#xD;
&#xD;
          -  Patients undergoing endovascular abdominal aneurysm repair or&#xD;
&#xD;
          -  Patients undergoing surgical lower limb revascularisation (suprainguinal or&#xD;
             infrainguinal)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years of age&#xD;
&#xD;
          -  Patients who are unable or unwilling to give full informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Significant upper limb peripheral arterial disease&#xD;
&#xD;
          -  Patients on glibenclamide or nicorandil (these medications may interfere with remote&#xD;
             ischaemic preconditioning)&#xD;
&#xD;
          -  Patients with an estimated pre-operative glomerular filtration rate &lt; 30mls/min/1.73m2&#xD;
&#xD;
          -  Patients with a history of myocarditis, pericarditis or amyloidosis&#xD;
&#xD;
          -  Patients undergoing Fenestrated or branched EVAR.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stewart R Walsh, MCh FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mid Western Regional Hospital and University of Limerick</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MidWestern Regional Hospital</name>
      <address>
        <city>Limerick</city>
        <zip>000</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <reference>
    <citation>Anderson PL, Gelijns A, Moskowitz A, Arons R, Gupta L, Weinberg A, Faries PL, Nowygrod R, Kent KC. Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000. J Vasc Surg. 2004 Jun;39(6):1200-8. doi: 10.1016/j.jvs.2004.02.039.</citation>
    <PMID>15192558</PMID>
  </reference>
  <reference>
    <citation>Chambers BR, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001923. doi: 10.1002/14651858.CD001923.pub2.</citation>
    <PMID>16235289</PMID>
  </reference>
  <reference>
    <citation>Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.</citation>
    <PMID>15351191</PMID>
  </reference>
  <reference>
    <citation>Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.</citation>
    <PMID>3769170</PMID>
  </reference>
  <reference>
    <citation>Jenkins DP, Pugsley WB, Alkhulaifi AM, Kemp M, Hooper J, Yellon DM. Ischaemic preconditioning reduces troponin T release in patients undergoing coronary artery bypass surgery. Heart. 1997 Apr;77(4):314-8. doi: 10.1136/hrt.77.4.314.</citation>
    <PMID>9155608</PMID>
  </reference>
  <reference>
    <citation>Clavien PA, Selzner M, Rudiger HA, Graf R, Kadry Z, Rousson V, Jochum W. A prospective randomized study in 100 consecutive patients undergoing major liver resection with versus without ischemic preconditioning. Ann Surg. 2003 Dec;238(6):843-50; discussion 851-2. doi: 10.1097/01.sla.0000098620.27623.7d.</citation>
    <PMID>14631221</PMID>
  </reference>
  <reference>
    <citation>Walsh 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.</citation>
    <PMID>18783958</PMID>
  </reference>
  <reference>
    <citation>Przyklenk K, Bauer B, Ovize M, Kloner RA, Whittaker P. Regional ischemic 'preconditioning' protects remote virgin myocardium from subsequent sustained coronary occlusion. Circulation. 1993 Mar;87(3):893-9. doi: 10.1161/01.cir.87.3.893.</citation>
    <PMID>7680290</PMID>
  </reference>
  <reference>
    <citation>Birnbaum Y, Hale SL, Kloner RA. Ischemic preconditioning at a distance: reduction of myocardial infarct size by partial reduction of blood supply combined with rapid stimulation of the gastrocnemius muscle in the rabbit. Circulation. 1997 Sep 2;96(5):1641-6. doi: 10.1161/01.cir.96.5.1641.</citation>
    <PMID>9315559</PMID>
  </reference>
  <reference>
    <citation>Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.</citation>
    <PMID>12460865</PMID>
  </reference>
  <reference>
    <citation>Oxman T, Arad M, Klein R, Avazov N, Rabinowitz B. Limb ischemia preconditions the heart against reperfusion tachyarrhythmia. Am J Physiol. 1997 Oct;273(4):H1707-12. doi: 10.1152/ajpheart.1997.273.4.H1707.</citation>
    <PMID>9362234</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>June 2, 2015</last_update_submitted>
  <last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mid Western Regional Hospital, Ireland</investigator_affiliation>
    <investigator_full_name>Professor Stewart Walsh</investigator_full_name>
    <investigator_title>Professor Stewart Walsh</investigator_title>
  </responsible_party>
  <keyword>Vascular disease</keyword>
  <keyword>Open aortic aneurysm repair</keyword>
  <keyword>Endovascular aneurysm repair</keyword>
  <keyword>Carotid endartrectomy</keyword>
  <keyword>Lower limb surgical revascularisation</keyword>
  <keyword>Major lower limb amputation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01691911
org study id: SAVES-123
nct id: NCT01691911
lead sponsor: 
has dmc: Yes
Major vascular surgery involves operations to repair swollen blood vessels, clear debris from
      blocked arteries or bypass blocked blood vessels. Patients with these problems are a
      high-risk surgical group as they have generalized blood vessel disease. These puts them at
      risk of major complications around the time of surgery such as heart attacks , strokes and
      death. The mortality following repair of a swollen main artery in the abdomen is about 1 in
      20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple
      and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote
      ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to
      muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a
      further five minutes. This cycle is repeated three more times. The blood supply is
      interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated
      brief interruption of the muscular blood supply sends signals to critical organs such as the
      brain and heart, which are rendered temporarily resistant to damage from reduced blood
      supply. Several small randomized clinical trials in patients undergoing different types of
      major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial
      aims to determine whether RIPC can reduce complications in routine practice.
The demand for major vascular surgery is increasing [1]. Patients requiring procedures such
      as aortic aneurysm repair, carotid endarterectomy, lower limb surgical re-vascularisation and
      major lower limb amputation for end-stage vascular disease constitute a high-risk surgical
      cohort. Peri-operative complications such as myocardial infarction, cerebrovascular accident,
      renal failure and death are common [2,3]. Multiple potential mechanisms may result in these
      complications. For example, myocardial injury may result from systemic hypotension leading to
      reduced flow across a tight coronary artery stenosis or, alternatively, it may arise due to
      acute occlusion when an unstable plaque ruptures. Most strategies aimed at peri-operative
      risk reduction target a single potential mechanism. For example, beta-blockade may prevent
      myocardial injury due to overwork, but cannot prevent acute coronary occlusion. There is a
      requirement for a simple, effective intervention that protects tissues against injury via
      multiple different mechanisms. Remote ischemic preconditioning (RIPC) may be suitable.

      Ischemic preconditioning is a phenomenon whereby a brief period of non-lethal ischemia in a
      tissue renders it resistant to the effects of a subsequent much longer ischaemic insult. It
      was first described in the canine heart [4]. Subsequent clinical trials showed that ischemic
      preconditioning reduced heart muscle damage following coronary artery bypass grafting [5] and
      liver dysfunction following hepatic resection [6]. Following cardiac surgery, it is
      associated with a reduction in critical care stay, arrhythmias and inotrope use [7]. However,
      ischemic preconditioning requires direct interference with the target tissues' blood supply,
      limiting its clinical utility. Further experimental work suggested that brief ischemia in one
      tissue, such as the kidneys, could confer protection on distant organs such as the heart [8].
      A similar effect was observed after transient skeletal muscle ischemia [9-11]. This effect is
      referred to as 'preconditioning at a distance' or 'remote ischemic preconditioning' (RIPC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Major Adverse Clinical Events
time frame: 30 day
description: The primary endpoint for the trial will be Major Adverse Clinical Events. This is a composite endpoint comprising any of: cardiovascular death, myocardial infarction, new onset arrhythmia requiring treatment, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischaemia requiring intervention or biopsy proven ischaemic colitis, urgent cardiac revascularisation. All participants will undergo a serum troponin levels and 12-lead electrocardiogram on the second post-operative day to screen for silent peri-operative myocardial infarction. Trial ECGs and troponin levels will be interpreted by a blinded trial cardiologist.
measure: Duration of post-operative hospital stay
time frame: 30 day
description: The duration of hospital stay and ITU stay have a major impact on health service resource utilisation, and are factors which can be influenced by surgery.
measure: Duration of intensive care unit stay
time frame: 30 day
description: The duration of hospital stay and ITU stay have a major impact on health service resource utilisation, and are factors which can be influenced by surgery.
measure: Unplanned critical care unit admission
time frame: 30 day
description: The duration of hospital stay and ITU stay have a major impact on health service resource utilisation, and are factors which can be influenced by surgery.
measure: Acute kidney injury score in first three peri-operative days
time frame: 3 days
description: The Acute Kidney Injury Score will be calculated over the first three peri-operative days. Creatinine will be measured daily as part of routine care. Urine volumes will be calculated from the fluid balance charts maintained as part of usual care.
measure: Peri-operative myocardial injury
time frame: from operation to 72 hours postoperatively
description: Peri-operative myocardial injury will be assessed by measurement of serum troponin levels. This will be achieved by comparing area under the curve (AUC) for serum troponin concentration over the first three post-operative days.
arm group label: Remote preconditioning
arm group type: Experimental
description: Preconditioning will be performed in the same manner as several previous trials. Immediately after induction of anaesthesia, a standard, CE-approved blood pressure cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure >185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles. In all other respects, the procedure and peri-operative care will follow the routine practices of the surgeons and anaesthetists involved.
arm group label: Remote preconditioning control
arm group type: No Intervention
description: Patients randomised to this group will receive routine pre-operative, peri-operative and post operative care.
intervention type: Procedure
intervention name: Remote preconditioning
description: Immediately after induction of anaesthesia, a standard, CE-approved tourniquet cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure >185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles. In all other respects, the procedure and peri-operative care will follow the routine practices of the surgeons and anaesthetists involved.
arm group label: Remote preconditioning
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stewart R Walsh, MCh FRCS
role: Principal Investigator
affiliation: Mid Western Regional Hospital and University of Limerick
facility: 
country: Ireland
citation: Anderson PL, Gelijns A, Moskowitz A, Arons R, Gupta L, Weinberg A, Faries PL, Nowygrod R, Kent KC. Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000. J Vasc Surg. 2004 Jun;39(6):1200-8. doi: 10.1016/j.jvs.2004.02.039.
PMID: 15192558
citation: Chambers BR, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001923. doi: 10.1002/14651858.CD001923.pub2.
PMID: 16235289
citation: Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.
PMID: 15351191
citation: Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.
PMID: 3769170
citation: Jenkins DP, Pugsley WB, Alkhulaifi AM, Kemp M, Hooper J, Yellon DM. Ischaemic preconditioning reduces troponin T release in patients undergoing coronary artery bypass surgery. Heart. 1997 Apr;77(4):314-8. doi: 10.1136/hrt.77.4.314.
PMID: 9155608
citation: Clavien PA, Selzner M, Rudiger HA, Graf R, Kadry Z, Rousson V, Jochum W. A prospective randomized study in 100 consecutive patients undergoing major liver resection with versus without ischemic preconditioning. Ann Surg. 2003 Dec;238(6):843-50; discussion 851-2. doi: 10.1097/01.sla.0000098620.27623.7d.
PMID: 14631221
citation: Walsh 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.
PMID: 18783958
citation: Przyklenk K, Bauer B, Ovize M, Kloner RA, Whittaker P. Regional ischemic 'preconditioning' protects remote virgin myocardium from subsequent sustained coronary occlusion. Circulation. 1993 Mar;87(3):893-9. doi: 10.1161/01.cir.87.3.893.
PMID: 7680290
citation: Birnbaum Y, Hale SL, Kloner RA. Ischemic preconditioning at a distance: reduction of myocardial infarct size by partial reduction of blood supply combined with rapid stimulation of the gastrocnemius muscle in the rabbit. Circulation. 1997 Sep 2;96(5):1641-6. doi: 10.1161/01.cir.96.5.1641.
PMID: 9315559
citation: Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.
PMID: 12460865
citation: Oxman T, Arad M, Klein R, Avazov N, Rabinowitz B. Limb ischemia preconditions the heart against reperfusion tachyarrhythmia. Am J Physiol. 1997 Oct;273(4):H1707-12. doi: 10.1152/ajpheart.1997.273.4.H1707.
PMID: 9362234
responsible party type: Principal Investigator
investigator affiliation: Mid Western Regional Hospital, Ireland
investigator full name: Professor Stewart Walsh
investigator title: Professor Stewart Walsh
mesh term: Carotid Artery Diseases
mesh term: Aneurysm
mesh term: Atherosclerosis
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Ischemia