<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/NCT03754673</url>
  </required_header>
  <id_info>
    <org_study_id>Plumonary MRI</org_study_id>
    <nct_id>NCT03754673</nct_id>
  </id_info>
  <brief_title>Role of MRI in Diagnosis of Pulmonary Embolism</brief_title>
  <official_title>Role of MRI in Diagnosis of Pulmonary Embolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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 aim of this work is to emphasize the role of non-contrast MR imaging in diagnosis of&#xD;
      acute pulmonary embolism in comparison to CTA and contrast enhanced MRA as gold standard&#xD;
      techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary embolism (PE) is a serious condition responsible for significant morbidity and&#xD;
      mortality. PE is currently the third leading cause of cardiovascular death worldwide, so it&#xD;
      requires prompt diagnosis and treatment to prevent potentially deadly consequences (1) .&#xD;
      Pulmonary embolism occurs when a blood clot-usually from the leg-travels to the lung and&#xD;
      blocks the pulmonary artery or one of its branches (2). The diagnosis of acute PE is&#xD;
      considered a clinical dilemma due to wide spectrum of multiple nonspecific signs and symptoms&#xD;
      (3) .&#xD;
&#xD;
      The D-dimer results are of bad positive laboratory test being positive in other situations&#xD;
      rather than PE such as cancer and inflammation (4) .&#xD;
&#xD;
      CT pulmonary angiography (CTA) is highly sensitive and specific for the diagnosis of PE and&#xD;
      has become the imaging method of choice in patients suspected of having PE. The multislice CT&#xD;
      offered high spatial and temporal resolution imaging in a short time scan. CTA has the&#xD;
      ability to assess the pulmonary tree down to the fifth and to eighth order branches in less&#xD;
      than 15 seconds due to high speed (5).&#xD;
&#xD;
      However, Limitations of CTPA include exposure to ionizing radiation with its risk of cancer&#xD;
      induction and iodinated contrast agent, which carries a risk of allergic reactions and kidney&#xD;
      damage and failure in some patients (6) .Many patients with suspected PE, such as pregnant&#xD;
      women and patients with impaired renal function, have at least a relative contraindication to&#xD;
      contrast media irradiation.&#xD;
&#xD;
      MRI offers a potential alternative to CTPA in the evaluation of the pulmonary vasculature and&#xD;
      the diagnosis of PE [7]. To date, however, the majority of studies evaluating the use of MRI&#xD;
      in the diagnosis of PE have used gadolinium based intravenous contrast media, which is&#xD;
      contraindicated in pregnant patients and in those with renal failure [8].&#xD;
&#xD;
      So, alternatively non contrast MRA improves diagnostic accuracy and simplify the acquisition&#xD;
      techniques remains an area of clinically important development. The non-contrast MRA produces&#xD;
      enhancing signal from the vessel wall, provides high contrast with no need for bolus timing&#xD;
      and provides motion-insensitivity to respiration (9).&#xD;
&#xD;
      The purpose of this study to evaluate the feasibility of detecting pulmonary emboli using non&#xD;
      contrast bright blood and dark blood MR imaging techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>detection of pulmonary embolism by MRI without contrast administration</measure>
    <time_frame>baseline</time_frame>
    <description>diagnosis and detection of pulmonary embolism by MRI in comparison with MSCT pulmonary angiography</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Pulmonary Embolism</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>MRI pulmonary with no contrast administration</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Full history taking and clinical examination.&#xD;
&#xD;
          2. CT PA or contrast enhanced MR PA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High clinical probability of PE assessed by the revised Geneva score and / or had a D-&#xD;
             dimer level &gt; 500 µg L1 on an ELISA-based test&#xD;
&#xD;
          -  Patients with clinically evident and confirmed by CT PA or contrast enhanced MR-PA to&#xD;
             have PE .&#xD;
&#xD;
          -  Both sexes will be included in addition to pregnant women.&#xD;
&#xD;
          -  No age predilection but children Less than 18 years old will not be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients known to have contraindication for MRI, e.g. an implanted magnetizable&#xD;
             device, metallic ocular implant, pacemakers, or claustrophobia.&#xD;
&#xD;
          -  Patients with bad general condition with signs of a severe PE such as unstable&#xD;
             haemodynamic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hossam Mohammed Mostafa</name>
      <address>
        <city>Assiut</city>
        <zip>020</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Nyren S, Nordgren Rogberg A, Vargas Paris R, Bengtsson B, Westerlund E, Lindholm P. Detection of pulmonary embolism using repeated MRI acquisitions without respiratory gating: a preliminary study. Acta Radiol. 2017 Mar;58(3):272-278. doi: 10.1177/0284185116651003. Epub 2016 Jul 19.</citation>
    <PMID>27273375</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 24, 2020</last_update_submitted>
  <last_update_submitted_qc>May 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>HMMostafa</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</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/NCT03754673
org study id: Plumonary MRI
nct id: NCT03754673
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this work is to emphasize the role of non-contrast MR imaging in diagnosis of
      acute pulmonary embolism in comparison to CTA and contrast enhanced MRA as gold standard
      techniques.
Pulmonary embolism (PE) is a serious condition responsible for significant morbidity and
      mortality. PE is currently the third leading cause of cardiovascular death worldwide, so it
      requires prompt diagnosis and treatment to prevent potentially deadly consequences (1) .
      Pulmonary embolism occurs when a blood clot-usually from the leg-travels to the lung and
      blocks the pulmonary artery or one of its branches (2). The diagnosis of acute PE is
      considered a clinical dilemma due to wide spectrum of multiple nonspecific signs and symptoms
      (3) .

      The D-dimer results are of bad positive laboratory test being positive in other situations
      rather than PE such as cancer and inflammation (4) .

      CT pulmonary angiography (CTA) is highly sensitive and specific for the diagnosis of PE and
      has become the imaging method of choice in patients suspected of having PE. The multislice CT
      offered high spatial and temporal resolution imaging in a short time scan. CTA has the
      ability to assess the pulmonary tree down to the fifth and to eighth order branches in less
      than 15 seconds due to high speed (5).

      However, Limitations of CTPA include exposure to ionizing radiation with its risk of cancer
      induction and iodinated contrast agent, which carries a risk of allergic reactions and kidney
      damage and failure in some patients (6) .Many patients with suspected PE, such as pregnant
      women and patients with impaired renal function, have at least a relative contraindication to
      contrast media irradiation.

      MRI offers a potential alternative to CTPA in the evaluation of the pulmonary vasculature and
      the diagnosis of PE [7]. To date, however, the majority of studies evaluating the use of MRI
      in the diagnosis of PE have used gadolinium based intravenous contrast media, which is
      contraindicated in pregnant patients and in those with renal failure [8].

      So, alternatively non contrast MRA improves diagnostic accuracy and simplify the acquisition
      techniques remains an area of clinically important development. The non-contrast MRA produces
      enhancing signal from the vessel wall, provides high contrast with no need for bolus timing
      and provides motion-insensitivity to respiration (9).

      The purpose of this study to evaluate the feasibility of detecting pulmonary emboli using non
      contrast bright blood and dark blood MR imaging techniques.
observational model: Case-Only
time perspective: Cross-Sectional
measure: detection of pulmonary embolism by MRI without contrast administration
time frame: baseline
description: diagnosis and detection of pulmonary embolism by MRI in comparison with MSCT pulmonary angiography
intervention type: Device
intervention name: MRI
description: MRI pulmonary with no contrast administration
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
facility: 
country: Egypt
citation: Nyren S, Nordgren Rogberg A, Vargas Paris R, Bengtsson B, Westerlund E, Lindholm P. Detection of pulmonary embolism using repeated MRI acquisitions without respiratory gating: a preliminary study. Acta Radiol. 2017 Mar;58(3):272-278. doi: 10.1177/0284185116651003. Epub 2016 Jul 19.
PMID: 27273375
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: HMMostafa
investigator title: Assistant Lecturer
mesh term: Pulmonary Embolism
mesh term: Embolism