xml: <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/NCT06025994</url>
    </required_header>
    <id_info>
      <org_study_id>488/2023/Sper/AOUFe</org_study_id>
      <nct_id>NCT06025994</nct_id>
    </id_info>
    <brief_title>Standardizing the Management of Patients With Coronary Microvascular Dysfunction</brief_title>
    <acronym>SAMCRO</acronym>
    <official_title>Standardizing the Management of Patients With Coronary Microvascular Dysfunction: the SAMCRO Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Consorzio Futuro in Ricerca</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Università degli Studi di Ferrara</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Abbott Medical Devices</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Consorzio Futuro in Ricerca</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>
        The SAMCRO is an all comers, prospective, randomized, multicenter, open-label study with&#xD;
        blinded adjudicated evaluation of outcomes (PROBE). The diagnosis of angina in non&#xD;
        obstructive coronary artery disease (ANOCA) will be confirmed with coronary artery&#xD;
        angiography and with the invasive assessment of coronary microvascular dysfunction (CMD) and&#xD;
        coronary vasomotion. At least 120 ANOCA patients with invasively confirmed CMD will be&#xD;
        randomized to i) multi-domain lifestyle intervention (experimental arm) vs. ii) standard of&#xD;
        care (control arm). All patients will undergo follow-up visits at 6, 12, 24, 36, 48 and 60&#xD;
        months. The study endpoints will be the improvement of angina status and quality of life as&#xD;
        assessed by validated questionnaires at one year. All participants in the multi-domain&#xD;
        lifestyle group will receive five different kinds of intervention: i) dietary counselling,&#xD;
        ii) strict management of cardiovascular (CV) and metabolic risk factors, iii) tailoring of&#xD;
        medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iv)&#xD;
        exercise training and v) psychological intervention. Patients randomized to the control group&#xD;
        will be managed according to current guidelines. The angina status will be assessed by the&#xD;
        Seattle Angina Questionnaire (SAQ). Quality of life will be assessed using the EuroQoL&#xD;
        (EQ5D-5L). Anxiety and depression will be assessed using the Beck Depression Inventory (BDI).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the SAMCRO trial is to determine whether a multidomain lifestyle intervention&#xD;
        improves angina status and quality of life in ANOCA patients as compared to current standard&#xD;
        of care.&#xD;
  &#xD;
        Patients will be randomized to:&#xD;
  &#xD;
        EXPERIMENTAL ARM: MULTI-DOMAIN LIFESTILE INTERVENTION&#xD;
  &#xD;
        Patients will receive five different kinds of intervention:&#xD;
  &#xD;
        i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on&#xD;
        the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary&#xD;
        counselling, iv) exercise training v) psychological counselling CONTROL ARM: STANDARD OF CARE&#xD;
        Patients randomized to the control group will be managed according to current guidelines&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>
      <intervention_model_description>The &quot; Standardizing the Management of patients with Coronary Microvascular Dysfunction (SAMCRO) &quot; trial is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of endpoints (PROBE).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The investigators in charge of follow-up visits and questionnaire collections will be different from investigators in charge of recruitment, baseline questionnaires collection and randomization procedure. The investigators in charge of follow-up procedures will be completely blinded to the randomization, as well as patient identifying information. Regarding clinical outcomes, an independent Clinical Event Committee (CEC) will adjudicate all endpoints. The CEC members and the CEC management team will be completely blinded to the randomization, as well as patient identifying information. Other measures to avoid or minimize bias introduced by the open-label design will include intent-to-treat principles of analysis and use of objective measures for endpoint classification.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Seattle Angina Questionnaire</measure>
      <time_frame>1-year</time_frame>
      <description>The primary efficacy endpoint is the value of Seattle Angina Questionnaire (SAQ) summary score. The SAQ-SS ranges from 0 to 100 and higher values indicate better outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>EQ visual analogue scale</measure>
      <time_frame>1-year</time_frame>
      <description>The continuous value of EQ visual analogue scale (EQ-VAS). The EQ-VAS scale ranges from 0 to 100 and higher values indicate better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Beck Depression Inventory (BDI)</measure>
      <time_frame>1-year</time_frame>
      <description>The continuous value of Beck Depression Inventory (BDI). BDI score ranges from 0 to 63. Higher scores indicate greater depressive severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical adverse events</measure>
      <time_frame>1-year</time_frame>
      <description>Cumulative occurrence of death, and hospital admission for any cause</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Microvascular Angina</condition>
    <condition>Microvascular Ischemia of Myocardium</condition>
    <arm_group>
      <arm_group_label>STANDARD OF CARE</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients randomized to the control group will be managed according to current guidelines</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MULTI-DOMAIN LIFESTILE INTERVENTION</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive five different kinds of intervention:&#xD;
  i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>MULTI-DOMAIN LIFESTILE INTERVENTION</intervention_name>
      <description>All participants in the multi-domain lifestyle group will receive five different kinds of intervention: i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) exercise training iv) dietary counselling, v) psychological intervention.</description>
      <arm_group_label>MULTI-DOMAIN LIFESTILE INTERVENTION</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient admitted to hospital for chronic coronary syndrome (CCS) with indication for&#xD;
               coronary artery angiography&#xD;
  &#xD;
            -  absence of obstructive coronary artery disease at invasive coronary artery angiography&#xD;
  &#xD;
            -  Coronary microvascular dysfunction as identified by invasive coronary physiology&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Planned coronary revascularization&#xD;
  &#xD;
            -  Co-morbidity reducing life expectancy to less than 1 year&#xD;
  &#xD;
            -  Any factor precluding 1-year follow-up&#xD;
  &#xD;
            -  Prior Coronary Artery Bypass Graft (CABG) surgery&#xD;
  &#xD;
            -  Presence of a chronic total occlusion (CTO)&#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>Gianluca Campo</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Ferrara</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Veronica Lodolini</last_name>
      <phone>0532236450</phone>
      <phone_ext>+39</phone_ext>
      <email>ldlvnc@unife.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>AOU Ferrara</name>
        <address>
          <city>Ferrara</city>
          <zip>44124</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>angina in non obstructive coronary artery disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
      <mesh_term>Microvascular Angina</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025994
  org study id: 488/2023/Sper/AOUFe
  nct id: NCT06025994
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The SAMCRO is an all comers, prospective, randomized, multicenter, open-label study with
        blinded adjudicated evaluation of outcomes (PROBE). The diagnosis of angina in non
        obstructive coronary artery disease (ANOCA) will be confirmed with coronary artery
        angiography and with the invasive assessment of coronary microvascular dysfunction (CMD) and
        coronary vasomotion. At least 120 ANOCA patients with invasively confirmed CMD will be
        randomized to i) multi-domain lifestyle intervention (experimental arm) vs. ii) standard of
        care (control arm). All patients will undergo follow-up visits at 6, 12, 24, 36, 48 and 60
        months. The study endpoints will be the improvement of angina status and quality of life as
        assessed by validated questionnaires at one year. All participants in the multi-domain
        lifestyle group will receive five different kinds of intervention: i) dietary counselling,
        ii) strict management of cardiovascular (CV) and metabolic risk factors, iii) tailoring of
        medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iv)
        exercise training and v) psychological intervention. Patients randomized to the control group
        will be managed according to current guidelines. The angina status will be assessed by the
        Seattle Angina Questionnaire (SAQ). Quality of life will be assessed using the EuroQoL
        (EQ5D-5L). Anxiety and depression will be assessed using the Beck Depression Inventory (BDI).
  The aim of the SAMCRO trial is to determine whether a multidomain lifestyle intervention
        improves angina status and quality of life in ANOCA patients as compared to current standard
        of care.
  
        Patients will be randomized to:
  
        EXPERIMENTAL ARM: MULTI-DOMAIN LIFESTILE INTERVENTION
  
        Patients will receive five different kinds of intervention:
  
        i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on
        the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary
        counselling, iv) exercise training v) psychological counselling CONTROL ARM: STANDARD OF CARE
        Patients randomized to the control group will be managed according to current guidelines
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The " Standardizing the Management of patients with Coronary Microvascular Dysfunction (SAMCRO) " trial is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of endpoints (PROBE).
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The investigators in charge of follow-up visits and questionnaire collections will be different from investigators in charge of recruitment, baseline questionnaires collection and randomization procedure. The investigators in charge of follow-up procedures will be completely blinded to the randomization, as well as patient identifying information. Regarding clinical outcomes, an independent Clinical Event Committee (CEC) will adjudicate all endpoints. The CEC members and the CEC management team will be completely blinded to the randomization, as well as patient identifying information. Other measures to avoid or minimize bias introduced by the open-label design will include intent-to-treat principles of analysis and use of objective measures for endpoint classification.
  measure: Seattle Angina Questionnaire
  time frame: 1-year
  description: The primary efficacy endpoint is the value of Seattle Angina Questionnaire (SAQ) summary score. The SAQ-SS ranges from 0 to 100 and higher values indicate better outcome
  measure: EQ visual analogue scale
  time frame: 1-year
  description: The continuous value of EQ visual analogue scale (EQ-VAS). The EQ-VAS scale ranges from 0 to 100 and higher values indicate better outcome
  measure: Beck Depression Inventory (BDI)
  time frame: 1-year
  description: The continuous value of Beck Depression Inventory (BDI). BDI score ranges from 0 to 63. Higher scores indicate greater depressive severity.
  measure: Clinical adverse events
  time frame: 1-year
  description: Cumulative occurrence of death, and hospital admission for any cause
  arm group label: STANDARD OF CARE
  arm group type: No Intervention
  description: Patients randomized to the control group will be managed according to current guidelines
  arm group label: MULTI-DOMAIN LIFESTILE INTERVENTION
  arm group type: Experimental
  description: Patients will receive five different kinds of intervention:
  i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling
  intervention type: Other
  intervention name: MULTI-DOMAIN LIFESTILE INTERVENTION
  description: All participants in the multi-domain lifestyle group will receive five different kinds of intervention: i) strict management of CV and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of CMD and coronary vasomotion, iii) exercise training iv) dietary counselling, v) psychological intervention.
  arm group label: MULTI-DOMAIN LIFESTILE INTERVENTION
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gianluca Campo
  role: Principal Investigator
  affiliation: University Hospital of Ferrara
  last name: Veronica Lodolini
  phone: 0532236450
  phone ext: +39
  email: ldlvnc@unife.it
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  mesh term: Microvascular Angina
  mesh term: Ischemia
  sharing ipd: Undecided