<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/NCT03010839</url>
  </required_header>
  <id_info>
    <org_study_id>XYFY-2017-001</org_study_id>
    <nct_id>NCT03010839</nct_id>
  </id_info>
  <brief_title>Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery</brief_title>
  <official_title>Cardiopulmonary Protection of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and&#xD;
      the lung.The heart and lung injury is a serious complication ,which increases both mortality&#xD;
      and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper&#xD;
      limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive&#xD;
      strategy.Recent some trials suggested that RIPC could provide myocardial protection by&#xD;
      reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed&#xD;
      to show the protective effects of RIPC with respect to the troponin release and lung injury.&#xD;
&#xD;
      Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase&#xD;
      organ protective effects, whether the modified RIPC protocol induced repeatedly has the&#xD;
      cardiopulmonary protective effect is still uncertain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective&#xD;
      effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia,&#xD;
      a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to&#xD;
      200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2016</start_date>
  <completion_date type="Actual">March 10, 2018</completion_date>
  <primary_completion_date type="Actual">January 10, 2018</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Troponin I serum release over 24 hours after surgery</measure>
    <time_frame>24 hours post surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PaO2/FiO2 ratio over 24 hours after surgery</measure>
    <time_frame>24 hours post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salveolar-arterial oxygen gradient over 24 hours after surgery</measure>
    <time_frame>24 hours post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inotrope score</measure>
    <time_frame>12 hours post surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Myocardial Injury</condition>
  <condition>Remote Ischemic Preconditioning</condition>
  <arm_group>
    <arm_group_label>Modified Remote Ischemic Preconditioning(mRIPC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC. The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group without remote ischemic preconditioning</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Modified Remote Ischemic Preconditioning</intervention_name>
    <description>mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg</description>
    <arm_group_label>Modified Remote Ischemic Preconditioning(mRIPC)</arm_group_label>
    <other_name>mRIPC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Control group witnout remote ischemic preconditioning</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing heart surgery on cardiopulmonary bypass&#xD;
&#xD;
          2. Patients aged 18 years to 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to give informed consent&#xD;
&#xD;
          2. Cardiogenic shock&#xD;
&#xD;
          3. Cardiac arrest on current admission&#xD;
&#xD;
          4. Left ventricular ejection fraction less than 30%&#xD;
&#xD;
          5. Current atrial fibrillation&#xD;
&#xD;
          6. Preoperative use of inotropics or mechanical assist device&#xD;
&#xD;
          7. Patients with significant hepatic dysfunction (Prothrombin&gt;2.0 ratio)&#xD;
&#xD;
          8. Patients with known renal failure with a GFR&lt;30 mL/min/1.73 m2&#xD;
&#xD;
          9. Patients with significant pulmonary disease (FEV1&lt;40% predicted)&#xD;
&#xD;
         10. Recent myocardial infarction (within 7 days)&#xD;
&#xD;
         11. Recent systemic infection or sepsis (within 7 days)&#xD;
&#xD;
         12. Severe stroke (within 2 months)&#xD;
&#xD;
         13. Significant peripheral arterial disease affecting the upper limbs&#xD;
&#xD;
         14. Previous serious psychiatric disorders (e.g. schizophrenia, dementia)&#xD;
&#xD;
         15. Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous&#xD;
             heart surgery,off-pump surgery, emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liu Su, M.D/Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Affiliated Hospital of Xuzhou Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical University</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Domanski MJ, Mahaffey K, Hasselblad V, Brener SJ, Smith PK, Hillis G, Engoren M, Alexander JH, Levy JH, Chaitman BR, Broderick S, Mack MJ, Pieper KS, Farkouh ME. Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery. JAMA. 2011 Feb 9;305(6):585-91. doi: 10.1001/jama.2011.99.</citation>
    <PMID>21304084</PMID>
  </results_reference>
  <results_reference>
    <citation>JENNINGS RB, SOMMERS HM, SMYTH GA, FLACK HA, LINN H. Myocardial necrosis induced by temporary occlusion of a coronary artery in the dog. Arch Pathol. 1960 Jul;70:68-78. No abstract available.</citation>
    <PMID>14407094</PMID>
  </results_reference>
  <results_reference>
    <citation>Braunwald E, Kloner RA. Myocardial reperfusion: a double-edged sword? J Clin Invest. 1985 Nov;76(5):1713-9. doi: 10.1172/JCI112160. No abstract available.</citation>
    <PMID>4056048</PMID>
  </results_reference>
  <results_reference>
    <citation>Sullivan PJ, Sweeney KJ, Hirpara KM, Malone CB, Curtin W, Kerin MJ. Cyclical ischaemic preconditioning modulates the adaptive immune response in human limb ischaemia-reperfusion injury. Br J Surg. 2009 Apr;96(4):381-90. doi: 10.1002/bjs.6554.</citation>
    <PMID>19283744</PMID>
  </results_reference>
  <results_reference>
    <citation>Bolli R. The late phase of preconditioning. Circ Res. 2000 Nov 24;87(11):972-83. doi: 10.1161/01.res.87.11.972.</citation>
    <PMID>11090541</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Gho BC, Schoemaker RG, van den Doel MA, Duncker DJ, Verdouw PD. Myocardial protection by brief ischemia in noncardiac tissue. Circulation. 1996 Nov 1;94(9):2193-200. doi: 10.1161/01.cir.94.9.2193.</citation>
    <PMID>8901671</PMID>
  </results_reference>
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    <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>
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    <citation>Li G, Labruto F, Sirsjo A, Chen F, Vaage J, Valen G. Myocardial protection by remote preconditioning: the role of nuclear factor kappa-B p105 and inducible nitric oxide synthase. Eur J Cardiothorac Surg. 2004 Nov;26(5):968-73. doi: 10.1016/j.ejcts.2004.06.015.</citation>
    <PMID>15519191</PMID>
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    <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>
  </results_reference>
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    <citation>Hausenloy 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.</citation>
    <PMID>18456674</PMID>
  </results_reference>
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    <citation>Sivaraman V, Pickard JM, Hausenloy DJ. Remote ischaemic conditioning: cardiac protection from afar. Anaesthesia. 2015 Jun;70(6):732-48. doi: 10.1111/anae.12973. Epub 2015 Feb 26.</citation>
    <PMID>25961420</PMID>
  </results_reference>
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    <citation>Heusch G, Botker HE, Przyklenk K, Redington A, Yellon D. Remote ischemic conditioning. J Am Coll Cardiol. 2015 Jan 20;65(2):177-95. doi: 10.1016/j.jacc.2014.10.031.</citation>
    <PMID>25593060</PMID>
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    <citation>Kerendi F, Kin H, Halkos ME, Jiang R, Zatta AJ, Zhao ZQ, Guyton RA, Vinten-Johansen J. Remote postconditioning. Brief renal ischemia and reperfusion applied before coronary artery reperfusion reduces myocardial infarct size via endogenous activation of adenosine receptors. Basic Res Cardiol. 2005 Sep;100(5):404-12. doi: 10.1007/s00395-005-0539-2. Epub 2005 Jun 17.</citation>
    <PMID>15965583</PMID>
  </results_reference>
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    <citation>Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.</citation>
    <PMID>17707752</PMID>
  </results_reference>
  <results_reference>
    <citation>Venugopal V, Hausenloy DJ, Ludman A, Di Salvo C, Kolvekar S, Yap J, Lawrence D, Bognolo J, Yellon DM. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing cardiac surgery with cold-blood cardioplegia: a randomised controlled trial. Heart. 2009 Oct;95(19):1567-71. doi: 10.1136/hrt.2008.155770. Epub 2009 Jun 8.</citation>
    <PMID>19508973</PMID>
  </results_reference>
  <results_reference>
    <citation>Thielmann M, Kottenberg E, Boengler K, Raffelsieper C, Neuhaeuser M, Peters J, Jakob H, Heusch G. Remote ischemic preconditioning reduces myocardial injury after coronary artery bypass surgery with crystalloid cardioplegic arrest. Basic Res Cardiol. 2010 Sep;105(5):657-64. doi: 10.1007/s00395-010-0104-5. Epub 2010 May 21.</citation>
    <PMID>20495811</PMID>
  </results_reference>
  <results_reference>
    <citation>Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhauser M, Peters J, Jakob H, Heusch G. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet. 2013 Aug 17;382(9892):597-604. doi: 10.1016/S0140-6736(13)61450-6. Erratum In: Lancet. 2013 Sep 14;382(9896):940.</citation>
    <PMID>23953384</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.</citation>
    <PMID>19188504</PMID>
  </results_reference>
  <results_reference>
    <citation>Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.</citation>
    <PMID>20189026</PMID>
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    <citation>Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Boning A, Niemann B, Roesner J, Kletzin F, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schon J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Hasenclever D, Zacharowski K; RIPHeart Study Collaborators. A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. N Engl J Med. 2015 Oct 8;373(15):1397-407. doi: 10.1056/NEJMoa1413579. Epub 2015 Oct 5.</citation>
    <PMID>26436208</PMID>
  </results_reference>
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    <citation>Hausenloy DJ, Candilio L, Evans R, Ariti C, Jenkins DP, Kolvekar S, Knight R, Kunst G, Laing C, Nicholas J, Pepper J, Robertson S, Xenou M, Clayton T, Yellon DM; ERICCA Trial Investigators. Remote Ischemic Preconditioning and Outcomes of Cardiac Surgery. N Engl J Med. 2015 Oct 8;373(15):1408-17. doi: 10.1056/NEJMoa1413534. Epub 2015 Oct 5.</citation>
    <PMID>26436207</PMID>
  </results_reference>
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    <citation>Remote Preconditioning Trialists' Group; Healy DA, Khan WA, Wong CS, Moloney MC, Grace PA, Coffey JC, Dunne C, Walsh SR, Sadat U, Gaunt ME, Chen S, Tehrani S, Hausenloy DJ, Yellon DM, Kramer RS, Zimmerman RF, Lomivorotov VV, Shmyrev VA, Ponomarev DN, Rahman IA, Mascaro JG, Bonser RS, Jeon Y, Hong DM, Wagner R, Thielmann M, Heusch G, Zacharowski K, Meybohm P, Bein B, Tang TY. Remote preconditioning and major clinical complications following adult cardiovascular surgery: systematic review and meta-analysis. Int J Cardiol. 2014 Sep;176(1):20-31. doi: 10.1016/j.ijcard.2014.06.018. Epub 2014 Jun 27.</citation>
    <PMID>25022819</PMID>
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    <citation>Lucchinetti E, Bestmann L, Feng J, Freidank H, Clanachan AS, Finegan BA, Zaugg M. Remote ischemic preconditioning applied during isoflurane inhalation provides no benefit to the myocardium of patients undergoing on-pump coronary artery bypass graft surgery: lack of synergy or evidence of antagonism in cardioprotection? Anesthesiology. 2012 Feb;116(2):296-310. doi: 10.1097/ALN.0b013e318242349a.</citation>
    <PMID>22222469</PMID>
  </results_reference>
  <results_reference>
    <citation>Hong DM, Lee EH, Kim HJ, Min JJ, Chin JH, Choi DK, Bahk JH, Sim JY, Choi IC, Jeon Y. Does remote ischaemic preconditioning with postconditioning improve clinical outcomes of patients undergoing cardiac surgery? Remote Ischaemic Preconditioning with Postconditioning Outcome Trial. Eur Heart J. 2014 Jan;35(3):176-83. doi: 10.1093/eurheartj/eht346. Epub 2013 Sep 7.</citation>
    <PMID>24014392</PMID>
  </results_reference>
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    <citation>Johnsen J, Pryds K, Salman R, Lofgren B, Kristiansen SB, Botker HE. The remote ischemic preconditioning algorithm: effect of number of cycles, cycle duration and effector organ mass on efficacy of protection. Basic Res Cardiol. 2016 Mar;111(2):10. doi: 10.1007/s00395-016-0529-6. Epub 2016 Jan 14.</citation>
    <PMID>26768477</PMID>
  </results_reference>
  <results_reference>
    <citation>Yamaguchi T, Izumi Y, Nakamura Y, Yamazaki T, Shiota M, Sano S, Tanaka M, Osada-Oka M, Shimada K, Miura K, Yoshiyama M, Iwao H. Repeated remote ischemic conditioning attenuates left ventricular remodeling via exosome-mediated intercellular communication on chronic heart failure after myocardial infarction. Int J Cardiol. 2015 Jan 15;178:239-46. doi: 10.1016/j.ijcard.2014.10.144. Epub 2014 Oct 30.</citation>
    <PMID>25464262</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 15, 2018</last_update_submitted>
  <last_update_submitted_qc>March 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xuzhou Medical University</investigator_affiliation>
    <investigator_full_name>Su Liu</investigator_full_name>
    <investigator_title>M.D/Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will be available when this trial is finished and the article have been published.</ipd_description>
  </patient_data>
  <!-- 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/NCT03010839
org study id: XYFY-2017-001
nct id: NCT03010839
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and
      the lung.The heart and lung injury is a serious complication ,which increases both mortality
      and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper
      limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive
      strategy.Recent some trials suggested that RIPC could provide myocardial protection by
      reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed
      to show the protective effects of RIPC with respect to the troponin release and lung injury.

      Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase
      organ protective effects, whether the modified RIPC protocol induced repeatedly has the
      cardiopulmonary protective effect is still uncertain.
modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective
      effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia,
      a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to
      200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Troponin I serum release over 24 hours after surgery
time frame: 24 hours post surgery
measure: PaO2/FiO2 ratio over 24 hours after surgery
time frame: 24 hours post surgery
measure: salveolar-arterial oxygen gradient over 24 hours after surgery
time frame: 24 hours post surgery
measure: Inotrope score
time frame: 12 hours post surgery
arm group label: Modified Remote Ischemic Preconditioning(mRIPC)
arm group type: Active Comparator
description: modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC. The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.
arm group label: Control
arm group type: Placebo Comparator
description: Control group without remote ischemic preconditioning
intervention type: Procedure
intervention name: Modified Remote Ischemic Preconditioning
description: mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
arm group label: Modified Remote Ischemic Preconditioning(mRIPC)
other name: mRIPC
intervention type: Procedure
intervention name: Control
description: Control group witnout remote ischemic preconditioning
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Liu Su, M.D/Ph.D
role: Principal Investigator
affiliation: The Affiliated Hospital of Xuzhou Medical University
facility: 
country: China
citation: Domanski MJ, Mahaffey K, Hasselblad V, Brener SJ, Smith PK, Hillis G, Engoren M, Alexander JH, Levy JH, Chaitman BR, Broderick S, Mack MJ, Pieper KS, Farkouh ME. Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery. JAMA. 2011 Feb 9;305(6):585-91. doi: 10.1001/jama.2011.99.
PMID: 21304084
citation: JENNINGS RB, SOMMERS HM, SMYTH GA, FLACK HA, LINN H. Myocardial necrosis induced by temporary occlusion of a coronary artery in the dog. Arch Pathol. 1960 Jul;70:68-78. No abstract available.
PMID: 14407094
citation: Braunwald E, Kloner RA. Myocardial reperfusion: a double-edged sword? J Clin Invest. 1985 Nov;76(5):1713-9. doi: 10.1172/JCI112160. No abstract available.
PMID: 4056048
citation: Sullivan PJ, Sweeney KJ, Hirpara KM, Malone CB, Curtin W, Kerin MJ. Cyclical ischaemic preconditioning modulates the adaptive immune response in human limb ischaemia-reperfusion injury. Br J Surg. 2009 Apr;96(4):381-90. doi: 10.1002/bjs.6554.
PMID: 19283744
citation: Bolli R. The late phase of preconditioning. Circ Res. 2000 Nov 24;87(11):972-83. doi: 10.1161/01.res.87.11.972.
PMID: 11090541
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
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responsible party type: Principal Investigator
investigator affiliation: Xuzhou Medical University
investigator full name: Su Liu
investigator title: M.D/Ph.D
mesh term: Ischemia
sharing ipd: No
ipd description: IPD will be available when this trial is finished and the article have been published.