<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/NCT01711099</url>
  </required_header>
  <id_info>
    <org_study_id>ANGEL_v01</org_study_id>
    <nct_id>NCT01711099</nct_id>
  </id_info>
  <brief_title>Efficacy of Extracorporeal Shockwave Myocardial Revascularization</brief_title>
  <acronym>ANGEL</acronym>
  <official_title>Hungarian Study on the Efficacy of Extracorporeal Shockwave Myocardial Revascularization in Patients With Therapy-refracter Angina Pectoris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salus Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Salus Ltd.</source>
  <brief_summary>
    <textblock>
      Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial&#xD;
      Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial&#xD;
      ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina&#xD;
      pectoris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in myocardial ischaemia profile during dobutamine induced stress echocardiography</measure>
    <time_frame>baseline and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in the angina pectoris CCS Stage</measure>
    <time_frame>baseline and 3, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in angina status using Seattle Angina Questionnaire</measure>
    <time_frame>baseline and 3, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in walking time using the modified Bruce exercise test</measure>
    <time_frame>baseline and 3, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in basal transthoracal echocardiographic parameters</measure>
    <time_frame>baseline and 3, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The decrease in nitrate use during the unchanged everyday activity reported by the patients in the &quot;Nitrate Usage Log&quot;</measure>
    <time_frame>baseline and 3, 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Refractory Angina Pectoris</condition>
  <arm_group>
    <arm_group_label>ESMR treated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy</intervention_name>
    <arm_group_label>ESMR treated</arm_group_label>
    <other_name>Cardiospec system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a signed Informed Consent Form.&#xD;
&#xD;
          -  Patient's current and past medical condition and status be assessed using previous&#xD;
             medical history, complete physical examination and the physicians (principle&#xD;
             investigator's) medical opinion.&#xD;
&#xD;
          -  Patient is diagnosed with chronic angina pectoris for at least 6 weeks. Diagnosis is&#xD;
             based on medical history, complete physical examination, and core labs.&#xD;
&#xD;
          -  Patients who no longer receive benefit from additional revascularization procedures&#xD;
             (i.e. CABG or Angioplasty). Certification will be made by Heart Team.&#xD;
&#xD;
          -  Patient demonstrates Exercise Tolerance Time (ETT) duration &lt; 10 minutes on Modified&#xD;
             Bruce protocol.&#xD;
&#xD;
          -  Patient had at least one documented myocardial segment with reversible ischemia.&#xD;
&#xD;
          -  Patient is under optimum medical therapy for angina for at least 6 weeks. The optimal&#xD;
             treatment plan is tailored to a person's age, the presence of other medical&#xD;
             conditions, lifestyle, medication side effects, etc. Medical therapies for stable&#xD;
             angina include ACE-inhibitors, Nitrates, Beta Blockers and Calcium Channel Blockers,&#xD;
             trimetazidine, ivabradin. Combination of any of 3 above mentioned drugs will be&#xD;
             considered as optimum medical therapy.&#xD;
&#xD;
          -  Patient has an echocardiographic acoustic window to the target area in the myocardium&#xD;
             utilizing one of the following views: apical 2 chamber view (2CH), apical 4 chamber&#xD;
             view (4CH), modified parasternal long axis view (LAX) and parasternal short axis view&#xD;
             (SAX).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who will substantially benefit from additional revascularization procedures&#xD;
             such as additional CABG or angioplasty therapies. This determination will be made and&#xD;
             certified by the Heart Team.&#xD;
&#xD;
          -  Patient has active endocarditis, myocarditis or pericarditis.&#xD;
&#xD;
          -  Patient with moderately severe or severe valvular disease.&#xD;
&#xD;
          -  Patient with known intraventricular thrombus.&#xD;
&#xD;
          -  Patients who have active or non-active implantables, such as pacemakers,&#xD;
             defibrillators, abandoned leads, or electrodes.&#xD;
&#xD;
          -  Patient for who shock waves applied over any implanted device that releases substances&#xD;
             or medications to the periphery (such as insulin pumps).&#xD;
&#xD;
          -  Patient is pregnant.&#xD;
&#xD;
          -  Patient with severe chronic lung disease (emphysema, pulmonary fibrosis) with&#xD;
             difficult access to ultrasonic acoustic window.&#xD;
&#xD;
          -  Patients for who shock waves applied over the area of healing fracture.&#xD;
&#xD;
          -  Patients for who shock waves applied over the area of bone growth.&#xD;
&#xD;
          -  Patients for who shock waves applied to the area of malignancy.&#xD;
&#xD;
          -  Prior invasive malignancy, except non-melanomatous skin cancer or other malignancies&#xD;
             with a documented disease-free survival for a minimum of 5 years.&#xD;
&#xD;
          -  By the physician decision there is underlying concomitant disease or circumstance what&#xD;
             may negatively influence the management of the patient.&#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>Béla Merkely, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmelweis University Heart Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Béla Merkely, Prof.</last_name>
    <phone>+36 1 4586840</phone>
    <email>titkarsag@kardio.sote.hu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kelen Hospital</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Imre Lukács, MD</last_name>
      <phone>+36 20 914 7300</phone>
      <email>luxi6@freemail.hu</email>
    </contact>
    <investigator>
      <last_name>Imre Lukács, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Semmelweis University Heart Center</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Béla Merkely, Prof</last_name>
      <phone>+36 1 4586840</phone>
      <email>titkarsag@kardio.sote.hu</email>
    </contact>
    <investigator>
      <last_name>Zoltán Jambrik, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>October 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2012</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>Angina Pectoris</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/NCT01711099
org study id: ANGEL_v01
nct id: NCT01711099
lead sponsor: 
Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial
      Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial
      ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina
      pectoris.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in myocardial ischaemia profile during dobutamine induced stress echocardiography
time frame: baseline and 6 months
measure: Improvement in the angina pectoris CCS Stage
time frame: baseline and 3, 6 months
measure: Improvement in angina status using Seattle Angina Questionnaire
time frame: baseline and 3, 6 months
measure: The change in walking time using the modified Bruce exercise test
time frame: baseline and 3, 6 months
measure: The change in basal transthoracal echocardiographic parameters
time frame: baseline and 3, 6 months
measure: The decrease in nitrate use during the unchanged everyday activity reported by the patients in the "Nitrate Usage Log"
time frame: baseline and 3, 6 months
arm group label: ESMR treated
arm group type: Experimental
intervention type: Device
intervention name: device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy
arm group label: ESMR treated
other name: Cardiospec system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Béla Merkely, Prof
role: Principal Investigator
affiliation: Semmelweis University Heart Center
last name: Béla Merkely, Prof.
phone: +36 1 4586840
email: titkarsag@kardio.sote.hu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Hungary
responsible party type: Sponsor
mesh term: Angina Pectoris