<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/NCT03832582</url>
  </required_header>
  <id_info>
    <org_study_id>P1700905J</org_study_id>
    <nct_id>NCT03832582</nct_id>
  </id_info>
  <brief_title>Annexin Imaging in Dissection of the Descending Aorta</brief_title>
  <acronym>PAIDDA</acronym>
  <official_title>Prognostic of Annexin Imaging in Dissection of the Descending Aorta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 relationship between the presence of a partial thrombus and aortic dilation after type B&#xD;
      dissection has recently been reported. The originality lies in the idea of imaging thrombus&#xD;
      activity to predict dilation after type B dissection. The innovative character is based on&#xD;
      the use of annexin scintigraphy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To establish the proof of concept in humans of the link between the intensity of&#xD;
      99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic&#xD;
      diameter in patients with type B aortic dissection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">May 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
  <phase>Phase 2</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending</measure>
    <time_frame>30 months</time_frame>
    <description>Pearson correlation coefficient between the rate of expansion of the aortic diameter measured by CT (at 6 months, 18 months and 30 months) in mm/year (at the site of maximum expansion) and the intensity of attachment of the annexin by the aortic wall descending in scintigraphy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (&lt; 2 mm/year, &gt;=2mm year) using ROC curve.</measure>
    <time_frame>30 months</time_frame>
    <description>Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (&lt; 2 mm/year, &gt;=2mm year) using ROC curve. The cut-off point will be defined by the Youden index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)</measure>
    <time_frame>30 months</time_frame>
    <description>Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)</measure>
    <time_frame>30 months</time_frame>
    <description>Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphological characteristics of the wall thrombus</measure>
    <time_frame>30 months</time_frame>
    <description>Morphological characteristics of the wall thrombus: no thrombus of the false lumen, partial thrombosis or total thrombosis of the false lumen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of potential predictive clinical factors of aortic dilation rate</measure>
    <time_frame>30 months</time_frame>
    <description>Determination of potential predictive clinical factors of aortic dilation rate: age, blood pressure, heart rate, sex, history of dissection, etiology (Marfan or no Marfan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of potential predictive SPECT factors of aortic dilation rate</measure>
    <time_frame>30 months</time_frame>
    <description>Determination of potential predictive SPECT factors of aortic dilation rate: anormal annexin binding, ratio of annexin binding (TBR = Target-to-Background Ratio)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of potential predictive biological factors of aortic dilation rate</measure>
    <time_frame>30 months</time_frame>
    <description>Determination of potential predictive biological factors (C-Reactive Protein) of aortic dilation rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of potential predictive morphological factors of aortic dilation rate</measure>
    <time_frame>30 months</time_frame>
    <description>Determination of potential predictive morphological factors of aortic dilation rate: no thrombus, partial thrombosis or total thrombosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cardiovascular events</measure>
    <time_frame>30 months</time_frame>
    <description>Number of cardiovascular events: cardiovascular death, dissection complications (including aortic rupture, malperfusion, emboli), aortic surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence</measure>
    <time_frame>3 days</time_frame>
    <description>Tolerance of the annexin scintigraphy will be assessed using a questionnaire during a phone call at day 3 to ask the patients about side effects occurrence.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">83</enrollment>
  <condition>Chronic Dissection of Thoracic Aorta (Disorder)</condition>
  <arm_group>
    <arm_group_label>Annexin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Annexin</intervention_name>
    <description>All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)</description>
    <arm_group_label>Annexin</arm_group_label>
    <other_name>Annexin scintigraphy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient whose age is ≥ 18 years old&#xD;
&#xD;
          -  any patient seen more than 6 months and less than 5 years after a dissection involving&#xD;
             the descending aorta at Bichat Hospital, whether it is a dissection of the descending&#xD;
             aorta alone or a dissection of the ascending aorta extended to the descending aorta&#xD;
&#xD;
          -  dissection of the uncomplicated descending thoracic aorta: not requiring surgery or&#xD;
             stent implantation within the first 6 months after acute dissection&#xD;
&#xD;
          -  effective contraception for women of childbearing age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  scheduled procedure for dissection of the descending aorta&#xD;
&#xD;
          -  contraindication to aortic CT with injection of contrast media: renal failure with&#xD;
             creatinine clearance &lt;30 ml/min or creatinine &gt;200 µmol/l; allergy to contrast media&#xD;
&#xD;
          -  history of surgery or stent implantation in the descending thoracic aorta&#xD;
&#xD;
          -  pregnant or breastfeeding women&#xD;
&#xD;
          -  patient under guardianship or trusteeship&#xD;
&#xD;
          -  non affiliation to social security or CMU (beneficiary or assignee)&#xD;
&#xD;
          -  patient refusal to participate in the study&#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>Olivier Milleron, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olivier Milleron, MD</last_name>
    <phone>00 33 1 40 25 68 16</phone>
    <email>olivier.milleron-ext@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service de Cardiologie - Hôpital Bichat Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Olivier Milleron, MD</last_name>
      <phone>00 33 1 40 25 68 16</phone>
      <email>olivier.milleron-ext@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 10, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aorta</keyword>
  <keyword>Type B dissection</keyword>
  <keyword>Descending aorta dissection</keyword>
  <keyword>Annexin</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03832582
org study id: P1700905J
nct id: NCT03832582
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The relationship between the presence of a partial thrombus and aortic dilation after type B
      dissection has recently been reported. The originality lies in the idea of imaging thrombus
      activity to predict dilation after type B dissection. The innovative character is based on
      the use of annexin scintigraphy.
To establish the proof of concept in humans of the link between the intensity of
      99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic
      diameter in patients with type B aortic dissection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending
time frame: 30 months
description: Pearson correlation coefficient between the rate of expansion of the aortic diameter measured by CT (at 6 months, 18 months and 30 months) in mm/year (at the site of maximum expansion) and the intensity of attachment of the annexin by the aortic wall descending in scintigraphy.
measure: Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve.
time frame: 30 months
description: Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve. The cut-off point will be defined by the Youden index.
measure: Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
time frame: 30 months
description: Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
measure: Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
time frame: 30 months
description: Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
measure: Morphological characteristics of the wall thrombus
time frame: 30 months
description: Morphological characteristics of the wall thrombus: no thrombus of the false lumen, partial thrombosis or total thrombosis of the false lumen.
measure: Determination of potential predictive clinical factors of aortic dilation rate
time frame: 30 months
description: Determination of potential predictive clinical factors of aortic dilation rate: age, blood pressure, heart rate, sex, history of dissection, etiology (Marfan or no Marfan)
measure: Determination of potential predictive SPECT factors of aortic dilation rate
time frame: 30 months
description: Determination of potential predictive SPECT factors of aortic dilation rate: anormal annexin binding, ratio of annexin binding (TBR = Target-to-Background Ratio)
measure: Determination of potential predictive biological factors of aortic dilation rate
time frame: 30 months
description: Determination of potential predictive biological factors (C-Reactive Protein) of aortic dilation rate
measure: Determination of potential predictive morphological factors of aortic dilation rate
time frame: 30 months
description: Determination of potential predictive morphological factors of aortic dilation rate: no thrombus, partial thrombosis or total thrombosis.
measure: Number of cardiovascular events
time frame: 30 months
description: Number of cardiovascular events: cardiovascular death, dissection complications (including aortic rupture, malperfusion, emboli), aortic surgery.
measure: Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence
time frame: 3 days
description: Tolerance of the annexin scintigraphy will be assessed using a questionnaire during a phone call at day 3 to ask the patients about side effects occurrence.
arm group label: Annexin
arm group type: Experimental
description: All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
intervention type: Drug
intervention name: Annexin
description: All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
arm group label: Annexin
other name: Annexin scintigraphy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier Milleron, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Olivier Milleron, MD
phone: 00 33 1 40 25 68 16
email: olivier.milleron-ext@aphp.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided