<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/NCT03015155</url>
  </required_header>
  <id_info>
    <org_study_id>LS-81570363</org_study_id>
    <nct_id>NCT03015155</nct_id>
  </id_info>
  <brief_title>Therapeutic Effect of Local Hypothermia in Treatment of Acute Myocardial Infarction</brief_title>
  <official_title>Effect of Local Myocardial Hypothermia on Outcomes in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent clinical studies have shown that systemic therapeutic hypothermia improving the&#xD;
      outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary&#xD;
      percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have&#xD;
      described the methods, mechanism and rationale of therapeutic hypothermia, including local&#xD;
      myocardial hypothermia. However, little is known of the local myocardial hypothermia having&#xD;
      impact on prognosis of the patients with acute myocardial infarction. The aim of this study&#xD;
      is to ascertain whether local myocardial hypothermia is effective in treatment of&#xD;
      ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ethics and organization The study was designed in agreement with the Declaration of Nanjing,&#xD;
      and the study protocol was approved by the local ethics committees. A written informed&#xD;
      consent will be completed before inclusion. The trial was coordinated and monitored by the&#xD;
      First Affiliated Hospital with Nanjing Medical University. An independent data and safety&#xD;
      monitoring board, including of physicians independent of the trial sponsor and operational&#xD;
      leadership, monitored the safety of the study.&#xD;
&#xD;
      Study population From March 2017 to March 2019, 300 patients from department of cardiology&#xD;
      (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China) will be&#xD;
      enrolled in this prospective, randomized, end point-blinded study to evaluate the local&#xD;
      hypothermia as an adjunct therapy in patients with acute myocardial infarction (AMI) eligible&#xD;
      for primary percutaneous intervention (PPCI). Men and women ages 40 and 80 years presenting&#xD;
      with anterior or non-anterior AMIs with ST-segment elevation&gt;0.2 mV in 2 contiguous leads and&#xD;
      a duration of symptoms&lt;12h will be included. We will collect a second electrocardiogram in&#xD;
      the catheterization laboratory before randomization to ensure persistent ST-segment&#xD;
      elevation. We conduct the exclusive criterion, including patients with previous AMIs,&#xD;
      previous PCI or coronary artery bypass grafting, congestive heart failure, end-stage kidney&#xD;
      disease or hepatic failure, recent stroke, coagulopathy, pregnancy, cardiac arrest, or Killip&#xD;
      class II to IV at presentation.&#xD;
&#xD;
      Protocol. The AMI patients will be randomized 1:1 to hypothermia or standard of care before&#xD;
      coronary angiography. Using varying block sizes and stratification, we generate the&#xD;
      randomization list by computer. A standard working guide-wire, Runthrough NS (Terumo&#xD;
      Corporation, Japan), is advanced into the distal part of the target coronary artery after&#xD;
      determining of the criminal vessel by using angiography. Compared to the standard PPCI after&#xD;
      the balloon expansion, the aspirated catheter (Diver C.E. MAX, Invatec S.p.A, Italy) is&#xD;
      firstly placed at the location of the distal occlusion lesion to achieve local myocardial&#xD;
      hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated&#xD;
      catheter, following the balloon expansion and the drug eluting stent implanting.&#xD;
      Subsequently, the infusion catheter is tautologically placed at the location of the opened&#xD;
      occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline&#xD;
      (4℃, 2.5ml/min, 15min). Loading doses of 300 mg of aspirin, 180 mg ticagrelor and heparin&#xD;
      (100u/kg) will be given to all patients before cardiac catheterization. Glycoprotein IIb/IIIa&#xD;
      inhibitors, bivalirudin and sodium nitroprusside will be administered at the discretion of&#xD;
      the treating physician.&#xD;
&#xD;
      Measurements To analyze the ventricular dimensions, myocardium at risk (MaR) and infarct&#xD;
      size, using postprocessing software, patients will be allocated to undergo cardiac magnetic&#xD;
      resonance examinations at the core laboratory (the First Affiliated Hospital with Nanjing&#xD;
      Medical University, Nanjing, China).&#xD;
&#xD;
      Troponin T/I, myoglobin, and creatine kinase-MB will be sampled before randomization and at&#xD;
      12 and 24 h after catheterization. We define the peak values as the highest measured values&#xD;
      within 24 h by calculating under area of the curve from the measurements. N-terminal&#xD;
      pro-brain natriuretic peptide will be sampled and dynamic electrocardiogram be performed at&#xD;
      48h after admission.&#xD;
&#xD;
      Clinical endpoints. Clinical events will be collected using a clinical report form during the&#xD;
      index hospital stay, at 30±10 days, and at 12 months. Furthermore, adverse event and serious&#xD;
      adverse event reporting will be collected as clinical endpoints. The independent monitors&#xD;
      supervise hospital charts for all patients. All primary events (death, re-infarction, target&#xD;
      lesion revascularization, major bleeding and heart failure) will be assessed independently by&#xD;
      a blinded clinical events committee.&#xD;
&#xD;
      Statistical analysis. Calculations and statistics will be performed by using the GraphPad&#xD;
      Prism 5.0 software (GraphPad Software Inc, La Jolla, Calif). The Fisher exact test will be&#xD;
      performed on categorical variables. Continuous variables will be tested using Mann-Whitney&#xD;
      Utest with exact inference. Statistical significance will be conducted at P&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infarct Size</measure>
    <time_frame>The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Hypothermia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infusion of Cold Saline into Local Infarction Myocardium. A standard working guide-wire, Runthrough NS (Terumo, Japan), is advanced into the distal part of the target coronary artery by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Italy) is firstly placed at the location of the distal occlusion lesion to achieve local myocardial hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated catheter, following the balloon expansion and the drug eluting stent implanting. Subsequently, the infusion catheter is tautologically placed at the location of the opened occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline (4℃, 2.5ml/min, 15min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>We place a standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), crossover the criminal lesion of to the distal of the target coronary artery after angiography. Then the pre-dilated balloon is placed at the occluded lesion site to expand the criminal vessel without hypothermia intervention. The operation will be completed when the flow of target coronary artery achieves TIMI class 3 after the drug eluting stent implanting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Infusion of Cold Saline into Local Infarction Myocardium.</intervention_name>
    <description>Infusion of Cold Saline into the Area of Ischemic Myocardium by Using Aspirated Catheter Before the Ischemia/reperfusion.</description>
    <arm_group_label>Hypothermia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who present with an anterior or inferior STEMI with ST-segment elevation of 0.2 mV&#xD;
        in &gt;2 or more anatomically contiguous leads and a duration of symptoms of &lt;6 hours are&#xD;
        included.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants with cardiac arrest, previous AMI, previous PCI or CABG, known congestive&#xD;
        heart failure, end-stage kidney disease or hepatic failure, coagulopathy, pregnancy, or&#xD;
        Killip class II through IV at presentation are excluded in this study.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lian-Sheng Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lian-Sheng Wang, MD, PhD</last_name>
    <phone>0086-25-83724440</phone>
    <email>drlswang@njmu.edu.cn</email>
  </overall_contact>
  <reference>
    <citation>Erlinge D, Gotberg M, Noc M, Lang I, Holzer M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Koul S, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Klos B, Harnek J, Olivecrona GK. Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials. Ther Hypothermia Temp Manag. 2015 Jun;5(2):77-84. doi: 10.1089/ther.2015.0009. Epub 2015 May 18.</citation>
    <PMID>25985169</PMID>
  </reference>
  <reference>
    <citation>Villablanca PA, Rao G, Briceno DF, Lombardo M, Ramakrishna H, Bortnick A, Garcia M, Menegus M, Sims D, Makkiya M, Mookadam F. Therapeutic hypothermia in ST elevation myocardial infarction: a systematic review and meta-analysis of randomised control trials. Heart. 2016 May;102(9):712-9. doi: 10.1136/heartjnl-2015-308559. Epub 2016 Feb 10.</citation>
    <PMID>26864673</PMID>
  </reference>
  <reference>
    <citation>Kohlhauer M, Berdeaux A, Ghaleh B, Tissier R. Therapeutic hypothermia to protect the heart against acute myocardial infarction. Arch Cardiovasc Dis. 2016 Dec;109(12):716-722. doi: 10.1016/j.acvd.2016.05.005. Epub 2016 Sep 28.</citation>
    <PMID>27692660</PMID>
  </reference>
  <results_reference>
    <citation>Kim H, Lee J, Song W, Shin J, Oh D, Harrison K, Jakkula M, Wong SC, Hong MK. Feasibility and safety of regional myocardial hypothermia during myocardial ischemia and infarction in pigs. Coron Artery Dis. 2005 Mar;16(2):125-9. doi: 10.1097/00019501-200503000-00008.</citation>
    <PMID>15735406</PMID>
  </results_reference>
  <results_reference>
    <citation>Otake H, Shite J, Paredes OL, Shinke T, Yoshikawa R, Tanino Y, Watanabe S, Ozawa T, Matsumoto D, Ogasawara D, Yokoyama M. Catheter-based transcoronary myocardial hypothermia attenuates arrhythmia and myocardial necrosis in pigs with acute myocardial infarction. J Am Coll Cardiol. 2007 Jan 16;49(2):250-60. doi: 10.1016/j.jacc.2006.06.080. Epub 2006 Dec 29.</citation>
    <PMID>17222738</PMID>
  </results_reference>
  <results_reference>
    <citation>Otterspoor LC, Van't Veer M, van Nunen LX, Wijnbergen I, Tonino PA, Pijls NH. Safety and feasibility of local myocardial hypothermia. Catheter Cardiovasc Interv. 2016 Apr;87(5):877-83. doi: 10.1002/ccd.26139. Epub 2015 Aug 13.</citation>
    <PMID>26269225</PMID>
  </results_reference>
  <results_reference>
    <citation>Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.</citation>
    <PMID>24509284</PMID>
  </results_reference>
  <results_reference>
    <citation>Dixon SR, Whitbourn RJ, Dae MW, Grube E, Sherman W, Schaer GL, Jenkins JS, Baim DS, Gibbons RJ, Kuntz RE, Popma JJ, Nguyen TT, O'Neill WW. Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction. J Am Coll Cardiol. 2002 Dec 4;40(11):1928-34. doi: 10.1016/s0735-1097(02)02567-6.</citation>
    <PMID>12475451</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Hypothermia</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/NCT03015155
org study id: LS-81570363
nct id: NCT03015155
lead sponsor: 
has dmc: Yes
Recent clinical studies have shown that systemic therapeutic hypothermia improving the
      outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary
      percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have
      described the methods, mechanism and rationale of therapeutic hypothermia, including local
      myocardial hypothermia. However, little is known of the local myocardial hypothermia having
      impact on prognosis of the patients with acute myocardial infarction. The aim of this study
      is to ascertain whether local myocardial hypothermia is effective in treatment of
      ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.
Ethics and organization The study was designed in agreement with the Declaration of Nanjing,
      and the study protocol was approved by the local ethics committees. A written informed
      consent will be completed before inclusion. The trial was coordinated and monitored by the
      First Affiliated Hospital with Nanjing Medical University. An independent data and safety
      monitoring board, including of physicians independent of the trial sponsor and operational
      leadership, monitored the safety of the study.

      Study population From March 2017 to March 2019, 300 patients from department of cardiology
      (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China) will be
      enrolled in this prospective, randomized, end point-blinded study to evaluate the local
      hypothermia as an adjunct therapy in patients with acute myocardial infarction (AMI) eligible
      for primary percutaneous intervention (PPCI). Men and women ages 40 and 80 years presenting
      with anterior or non-anterior AMIs with ST-segment elevation>0.2 mV in 2 contiguous leads and
      a duration of symptoms<12h will be included. We will collect a second electrocardiogram in
      the catheterization laboratory before randomization to ensure persistent ST-segment
      elevation. We conduct the exclusive criterion, including patients with previous AMIs,
      previous PCI or coronary artery bypass grafting, congestive heart failure, end-stage kidney
      disease or hepatic failure, recent stroke, coagulopathy, pregnancy, cardiac arrest, or Killip
      class II to IV at presentation.

      Protocol. The AMI patients will be randomized 1:1 to hypothermia or standard of care before
      coronary angiography. Using varying block sizes and stratification, we generate the
      randomization list by computer. A standard working guide-wire, Runthrough NS (Terumo
      Corporation, Japan), is advanced into the distal part of the target coronary artery after
      determining of the criminal vessel by using angiography. Compared to the standard PPCI after
      the balloon expansion, the aspirated catheter (Diver C.E. MAX, Invatec S.p.A, Italy) is
      firstly placed at the location of the distal occlusion lesion to achieve local myocardial
      hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated
      catheter, following the balloon expansion and the drug eluting stent implanting.
      Subsequently, the infusion catheter is tautologically placed at the location of the opened
      occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline
      (4℃, 2.5ml/min, 15min). Loading doses of 300 mg of aspirin, 180 mg ticagrelor and heparin
      (100u/kg) will be given to all patients before cardiac catheterization. Glycoprotein IIb/IIIa
      inhibitors, bivalirudin and sodium nitroprusside will be administered at the discretion of
      the treating physician.

      Measurements To analyze the ventricular dimensions, myocardium at risk (MaR) and infarct
      size, using postprocessing software, patients will be allocated to undergo cardiac magnetic
      resonance examinations at the core laboratory (the First Affiliated Hospital with Nanjing
      Medical University, Nanjing, China).

      Troponin T/I, myoglobin, and creatine kinase-MB will be sampled before randomization and at
      12 and 24 h after catheterization. We define the peak values as the highest measured values
      within 24 h by calculating under area of the curve from the measurements. N-terminal
      pro-brain natriuretic peptide will be sampled and dynamic electrocardiogram be performed at
      48h after admission.

      Clinical endpoints. Clinical events will be collected using a clinical report form during the
      index hospital stay, at 30±10 days, and at 12 months. Furthermore, adverse event and serious
      adverse event reporting will be collected as clinical endpoints. The independent monitors
      supervise hospital charts for all patients. All primary events (death, re-infarction, target
      lesion revascularization, major bleeding and heart failure) will be assessed independently by
      a blinded clinical events committee.

      Statistical analysis. Calculations and statistics will be performed by using the GraphPad
      Prism 5.0 software (GraphPad Software Inc, La Jolla, Calif). The Fisher exact test will be
      performed on categorical variables. Continuous variables will be tested using Mann-Whitney
      Utest with exact inference. Statistical significance will be conducted at P<0.05.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Infarct Size
time frame: The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.
arm group label: Hypothermia
arm group type: Experimental
description: Infusion of Cold Saline into Local Infarction Myocardium. A standard working guide-wire, Runthrough NS (Terumo, Japan), is advanced into the distal part of the target coronary artery by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Italy) is firstly placed at the location of the distal occlusion lesion to achieve local myocardial hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated catheter, following the balloon expansion and the drug eluting stent implanting. Subsequently, the infusion catheter is tautologically placed at the location of the opened occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline (4℃, 2.5ml/min, 15min).
arm group label: Standard treatment
arm group type: No Intervention
description: We place a standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), crossover the criminal lesion of to the distal of the target coronary artery after angiography. Then the pre-dilated balloon is placed at the occluded lesion site to expand the criminal vessel without hypothermia intervention. The operation will be completed when the flow of target coronary artery achieves TIMI class 3 after the drug eluting stent implanting.
intervention type: Procedure
intervention name: Infusion of Cold Saline into Local Infarction Myocardium.
description: Infusion of Cold Saline into the Area of Ischemic Myocardium by Using Aspirated Catheter Before the Ischemia/reperfusion.
arm group label: Hypothermia
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lian-Sheng Wang, MD, PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Lian-Sheng Wang, MD, PhD
phone: 0086-25-83724440
email: drlswang@njmu.edu.cn
citation: Erlinge D, Gotberg M, Noc M, Lang I, Holzer M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Koul S, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Klos B, Harnek J, Olivecrona GK. Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials. Ther Hypothermia Temp Manag. 2015 Jun;5(2):77-84. doi: 10.1089/ther.2015.0009. Epub 2015 May 18.
PMID: 25985169
citation: Villablanca PA, Rao G, Briceno DF, Lombardo M, Ramakrishna H, Bortnick A, Garcia M, Menegus M, Sims D, Makkiya M, Mookadam F. Therapeutic hypothermia in ST elevation myocardial infarction: a systematic review and meta-analysis of randomised control trials. Heart. 2016 May;102(9):712-9. doi: 10.1136/heartjnl-2015-308559. Epub 2016 Feb 10.
PMID: 26864673
citation: Kohlhauer M, Berdeaux A, Ghaleh B, Tissier R. Therapeutic hypothermia to protect the heart against acute myocardial infarction. Arch Cardiovasc Dis. 2016 Dec;109(12):716-722. doi: 10.1016/j.acvd.2016.05.005. Epub 2016 Sep 28.
PMID: 27692660
citation: Kim H, Lee J, Song W, Shin J, Oh D, Harrison K, Jakkula M, Wong SC, Hong MK. Feasibility and safety of regional myocardial hypothermia during myocardial ischemia and infarction in pigs. Coron Artery Dis. 2005 Mar;16(2):125-9. doi: 10.1097/00019501-200503000-00008.
PMID: 15735406
citation: Otake H, Shite J, Paredes OL, Shinke T, Yoshikawa R, Tanino Y, Watanabe S, Ozawa T, Matsumoto D, Ogasawara D, Yokoyama M. Catheter-based transcoronary myocardial hypothermia attenuates arrhythmia and myocardial necrosis in pigs with acute myocardial infarction. J Am Coll Cardiol. 2007 Jan 16;49(2):250-60. doi: 10.1016/j.jacc.2006.06.080. Epub 2006 Dec 29.
PMID: 17222738
citation: Otterspoor LC, Van't Veer M, van Nunen LX, Wijnbergen I, Tonino PA, Pijls NH. Safety and feasibility of local myocardial hypothermia. Catheter Cardiovasc Interv. 2016 Apr;87(5):877-83. doi: 10.1002/ccd.26139. Epub 2015 Aug 13.
PMID: 26269225
citation: Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.
PMID: 24509284
citation: Dixon SR, Whitbourn RJ, Dae MW, Grube E, Sherman W, Schaer GL, Jenkins JS, Baim DS, Gibbons RJ, Kuntz RE, Popma JJ, Nguyen TT, O'Neill WW. Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction. J Am Coll Cardiol. 2002 Dec 4;40(11):1928-34. doi: 10.1016/s0735-1097(02)02567-6.
PMID: 12475451
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Hypothermia
sharing ipd: No