<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/NCT03018873</url>
  </required_header>
  <id_info>
    <org_study_id>XuanwuH-RIPC1</org_study_id>
    <nct_id>NCT03018873</nct_id>
  </id_info>
  <brief_title>Long-term Remote Ischemic Preconditioning Improve the Prognosis of Myocardial Infarction Patients With Emergency Reperfusion Therapy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with acute myocardial infarction (AMI) are in critical condition. When primary&#xD;
      percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart&#xD;
      failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic&#xD;
      preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will&#xD;
      investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients&#xD;
      short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were&#xD;
      randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once&#xD;
      RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group (without&#xD;
      RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine,&#xD;
      vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1),&#xD;
      echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after&#xD;
      PCI. Patients will be followed up by telephone at the end of one year. The major adverse&#xD;
      cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction,&#xD;
      unplanned revascularization and stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">July 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>major adverse cardiovascular events</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Myocardial Infarction, Acute</condition>
  <arm_group>
    <arm_group_label>long-term RIPC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>routine treatment + interventions interventions: once preoperative RIPC and once RIPC/day after PCI for one year. Once preoperative remote ischemic preconditioning （RIPC） : Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg before primary percutaneous coronary intervention(PCI).&#xD;
Once RIPC/day after PCI for one year:Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preoperative RIPC group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>routine treatment + Once preoperative remote ischemic preconditioning （RIPC） : Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg before primary percutaneous coronary intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine treatment, no RIPC</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>remote ischemic preconditioning （RIPC）</intervention_name>
    <description>once RIPC: three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.</description>
    <arm_group_label>long-term RIPC group</arm_group_label>
    <arm_group_label>preoperative RIPC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-80 years;&#xD;
&#xD;
          -  ST segment elevation myocardial infarction (STEMI);&#xD;
&#xD;
          -  Plan to primary percutaneous coronary intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age more than 80;&#xD;
&#xD;
          -  renal failure with creatinine &gt;2 mg/dl;&#xD;
&#xD;
          -  reject taking part in the study.&#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_contact>
    <last_name>Liu zhi, doctor</last_name>
    <phone>13911517967</phone>
    <email>xwyy168@sina.com</email>
  </overall_contact>
  <reference>
    <citation>Tobis J. Is no-no-reflow following PCI in AMI due to distal embolization of plaque and thrombus? Catheter Cardiovasc Interv. 2013 Aug 1;82(2):210-1. doi: 10.1002/ccd.25078. No abstract available.</citation>
    <PMID>23878032</PMID>
  </reference>
  <reference>
    <citation>Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011.</citation>
    <PMID>24156966</PMID>
  </reference>
  <reference>
    <citation>Schmidt MR, Sloth AD, Johnsen J, Botker HE. Remote ischemic conditioning: the cardiologist's perspective. J Cardiovasc Med (Hagerstown). 2012 Nov;13(11):667-74. doi: 10.2459/JCM.0b013e328357bff2.</citation>
    <PMID>23114270</PMID>
  </reference>
  <reference>
    <citation>Szijarto A, Czigany Z, Turoczi Z, Harsanyi L. Remote ischemic perconditioning--a simple, low-risk method to decrease ischemic reperfusion injury: models, protocols and mechanistic background. A review. J Surg Res. 2012 Dec;178(2):797-806. doi: 10.1016/j.jss.2012.06.067. Epub 2012 Jul 28.</citation>
    <PMID>22868050</PMID>
  </reference>
  <reference>
    <citation>Ghaemian A, Nouraei SM, Abdollahian F, Naghshvar F, Giussani DA, Nouraei SA. Remote ischemic preconditioning in percutaneous coronary revascularization: a double-blind randomized controlled clinical trial. Asian Cardiovasc Thorac Ann. 2012 Oct;20(5):548-54. doi: 10.1177/0218492312439999.</citation>
    <PMID>23087298</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <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>
  </reference>
  <reference>
    <citation>Shimizu M, Saxena P, Konstantinov IE, Cherepanov V, Cheung MM, Wearden P, Zhangdong H, Schmidt M, Downey GP, Redington AN. Remote ischemic preconditioning decreases adhesion and selectively modifies functional responses of human neutrophils. J Surg Res. 2010 Jan;158(1):155-61. doi: 10.1016/j.jss.2008.08.010.</citation>
    <PMID>19540519</PMID>
  </reference>
  <reference>
    <citation>Hu S, Dong HL, Li YZ, Luo ZJ, Sun L, Yang QZ, Yang LF, Xiong L. Effects of remote ischemic preconditioning on biochemical markers and neurologic outcomes in patients undergoing elective cervical decompression surgery: a prospective randomized controlled trial. J Neurosurg Anesthesiol. 2010 Jan;22(1):46-52. doi: 10.1097/ANA.0b013e3181c572bd. Erratum In: J Neurosurg Anesthesiol. 2010 Apr;22(2):157.</citation>
    <PMID>19996767</PMID>
  </reference>
  <reference>
    <citation>Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.</citation>
    <PMID>23035060</PMID>
  </reference>
  <reference>
    <citation>D'Ascenzo F, Moretti C, Omede P, Cerrato E, Cavallero E, Er F, Presutti DG, Colombo F, Crimi G, Conrotto F, Dinicolantonio JJ, Chen S, Prasad A, Biondi Zoccai G, Gaita F. Cardiac remote ischaemic preconditioning reduces periprocedural myocardial infarction for patients undergoing percutaneous coronary interventions: a meta-analysis of randomised clinical trials. EuroIntervention. 2014;9(12):1463-71. doi: 10.4244/EIJV9I12A244.</citation>
    <PMID>24755386</PMID>
  </reference>
  <reference>
    <citation>Liu Z, Wang YL, Hua Q, Chu YY, Ji XM. Late remote ischemic preconditioning provides benefit to patients undergoing elective percutaneous coronary intervention. Cell Biochem Biophys. 2014 Sep;70(1):437-42. doi: 10.1007/s12013-014-9936-1.</citation>
    <PMID>25015066</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>remote ischemic preconditioning</keyword>
  <keyword>acute myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03018873
org study id: XuanwuH-RIPC1
nct id: NCT03018873
lead sponsor: 
has dmc: No
Patients with acute myocardial infarction (AMI) are in critical condition. When primary
      percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart
      failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic
      preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will
      investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients
      short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were
      randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once
      RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group (without
      RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine,
      vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1),
      echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after
      PCI. Patients will be followed up by telephone at the end of one year. The major adverse
      cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction,
      unplanned revascularization and stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: major adverse cardiovascular events
time frame: one year
arm group label: long-term RIPC group
arm group type: Experimental
description: routine treatment + interventions interventions: once preoperative RIPC and once RIPC/day after PCI for one year. Once preoperative remote ischemic preconditioning （RIPC） : Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg before primary percutaneous coronary intervention(PCI).
Once RIPC/day after PCI for one year:Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
arm group label: preoperative RIPC group
arm group type: Active Comparator
description: routine treatment + Once preoperative remote ischemic preconditioning （RIPC） : Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg before primary percutaneous coronary intervention.
arm group label: control group
arm group type: No Intervention
description: routine treatment, no RIPC
intervention type: Other
intervention name: remote ischemic preconditioning （RIPC）
description: once RIPC: three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
arm group label: long-term RIPC group
arm group label: preoperative RIPC group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Liu zhi, doctor
phone: 13911517967
email: xwyy168@sina.com
citation: Tobis J. Is no-no-reflow following PCI in AMI due to distal embolization of plaque and thrombus? Catheter Cardiovasc Interv. 2013 Aug 1;82(2):210-1. doi: 10.1002/ccd.25078. No abstract available.
PMID: 23878032
citation: Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011.
PMID: 24156966
citation: Schmidt MR, Sloth AD, Johnsen J, Botker HE. Remote ischemic conditioning: the cardiologist's perspective. J Cardiovasc Med (Hagerstown). 2012 Nov;13(11):667-74. doi: 10.2459/JCM.0b013e328357bff2.
PMID: 23114270
citation: Szijarto A, Czigany Z, Turoczi Z, Harsanyi L. Remote ischemic perconditioning--a simple, low-risk method to decrease ischemic reperfusion injury: models, protocols and mechanistic background. A review. J Surg Res. 2012 Dec;178(2):797-806. doi: 10.1016/j.jss.2012.06.067. Epub 2012 Jul 28.
PMID: 22868050
citation: Ghaemian A, Nouraei SM, Abdollahian F, Naghshvar F, Giussani DA, Nouraei SA. Remote ischemic preconditioning in percutaneous coronary revascularization: a double-blind randomized controlled clinical trial. Asian Cardiovasc Thorac Ann. 2012 Oct;20(5):548-54. doi: 10.1177/0218492312439999.
PMID: 23087298
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.
PMID: 20189026
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.
PMID: 17707752
citation: Shimizu M, Saxena P, Konstantinov IE, Cherepanov V, Cheung MM, Wearden P, Zhangdong H, Schmidt M, Downey GP, Redington AN. Remote ischemic preconditioning decreases adhesion and selectively modifies functional responses of human neutrophils. J Surg Res. 2010 Jan;158(1):155-61. doi: 10.1016/j.jss.2008.08.010.
PMID: 19540519
citation: Hu S, Dong HL, Li YZ, Luo ZJ, Sun L, Yang QZ, Yang LF, Xiong L. Effects of remote ischemic preconditioning on biochemical markers and neurologic outcomes in patients undergoing elective cervical decompression surgery: a prospective randomized controlled trial. J Neurosurg Anesthesiol. 2010 Jan;22(1):46-52. doi: 10.1097/ANA.0b013e3181c572bd. Erratum In: J Neurosurg Anesthesiol. 2010 Apr;22(2):157.
PMID: 19996767
citation: Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
PMID: 23035060
citation: D'Ascenzo F, Moretti C, Omede P, Cerrato E, Cavallero E, Er F, Presutti DG, Colombo F, Crimi G, Conrotto F, Dinicolantonio JJ, Chen S, Prasad A, Biondi Zoccai G, Gaita F. Cardiac remote ischaemic preconditioning reduces periprocedural myocardial infarction for patients undergoing percutaneous coronary interventions: a meta-analysis of randomised clinical trials. EuroIntervention. 2014;9(12):1463-71. doi: 10.4244/EIJV9I12A244.
PMID: 24755386
citation: Liu Z, Wang YL, Hua Q, Chu YY, Ji XM. Late remote ischemic preconditioning provides benefit to patients undergoing elective percutaneous coronary intervention. Cell Biochem Biophys. 2014 Sep;70(1):437-42. doi: 10.1007/s12013-014-9936-1.
PMID: 25015066
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No