<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/NCT03783117</url>
  </required_header>
  <id_info>
    <org_study_id>201801</org_study_id>
    <nct_id>NCT03783117</nct_id>
  </id_info>
  <brief_title>Magneto-rheology to Lower Blood Pressure</brief_title>
  <official_title>Reducing Blood Viscosity and Suppressing Turbulence With Magneto-rheology to Lower Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiovascular Therapy LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiovascular Therapy LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart attacks and strokes are the leading causes of death in US. High blood viscosity and&#xD;
      turbulence in blood flow are the key for cardiovascular diseases. Recent research has shown&#xD;
      that application of a strong magnetic field along the blood flow direction will polarize the&#xD;
      red blood cells and align them into short chains along the flow, so that the blood viscosity&#xD;
      in the flow direction is reduced significantly and disturbed motions in the directions&#xD;
      perpendicular to the flow is suppressed. This makes the blood flow laminar, turbulence&#xD;
      suppressed, and the possibility of cardiac events reduced. Such magnet treatment also cures&#xD;
      rouleaux and improves the blood's oxygen function. The lab tests also confirm that the above&#xD;
      effects last more than 24 hours after one treatment.&#xD;
&#xD;
      The purpose of this trial is to apply this technology to humans. According to the lab tests,&#xD;
      this magnetic treatment has the potential to bring the following benefits to the subjects:&#xD;
      (a)The blood viscosity will be reduced by 10-20% or more. (b) The turbulence in blood&#xD;
      circulation will be suppressed by the treatment. After the treatment, the blood flow will be&#xD;
      laminar. As a joint effect of viscosity reduction and turbulence suppression, the blood&#xD;
      pressure will be lowered by 10-20% or more. (c) The subject's blood oxygen function will be&#xD;
      improved by the treatment. Especially, if the subject has rouleaux in his/her blood, the&#xD;
      effect will be significant. (d) The above effects will last for about 24 hours after one&#xD;
      treatment and slowly decay; however, re-treatment will bring the effects back. (e) Because&#xD;
      steady laminar blood flow is atheroprotective by active reduction of inflammatory genes, the&#xD;
      magnetic treatment, reducing disturbed blood flow hemodynamics, would be possible to have a&#xD;
      long term effect as an anti-atherogenic therapy if the treatment keeps for a while.&#xD;
&#xD;
      The investigators have just completed the pilot clinical trial. The tests confirm that the&#xD;
      technology is safe and effective in lowering the blood pressure and the effect lasts about 24&#xD;
      hours. The present pivotal clinical trials are the continuation and expansion of the pilot&#xD;
      tests. The successful clinical trials will make this technology available for people in&#xD;
      preventing heart attack and stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GOAL: Conduct pivotal clinical trials with Magnetic Blood Pressure Lowering (MBPL) Device,&#xD;
      developed in this lab, to see how effective it can lower patients' high blood pressure. The&#xD;
      pilot study has confirmed the safety and performance of the device. The pivotal tests will&#xD;
      test a large population of subject with hypertension to determine the effectiveness of the&#xD;
      MBPL device and check if there is any adverse effect.&#xD;
&#xD;
      RECRUITMENT: For the pivotal clinical trials, subjects in second stage of hypertension will&#xD;
      be selected: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood&#xD;
      pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic&#xD;
      devices implanted, will not be selected. In addition, any adults unable to consent,&#xD;
      cognitively impaired adults, and subjects who are not yet adults (infants, children,&#xD;
      teenagers), pregnant women, and prisoners, will not be admitted.&#xD;
&#xD;
      STUDY: The MBPL device for clinical trials is made with modification of an electromagnet: A&#xD;
      bore of 10 cm diameter was made to go through the frame and poles. The device can produce a&#xD;
      magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial&#xD;
      for each subject takes about 20-30 minutes. The subject's blood pressure will be measured&#xD;
      first. Afterwards, the subject will place his/her right arm into the bore of the&#xD;
      electromagnet for treatment while the blood pressure is monitored with the left arm. The&#xD;
      magnetic treatment will last about 15 minutes.&#xD;
&#xD;
      In order to see how long the effect lasts, the subject needs to return and measure the blood&#xD;
      pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is&#xD;
      no medicine or surgery involved.&#xD;
&#xD;
      ANALYSES: During the magnetic treatment, the MBPL device applies a strong magnetic field&#xD;
      along the blood flow direction in subjects' right arm. Under the magnetic field, the&#xD;
      deoxygenated red blood cells are polarized and form short chains along the blood flow&#xD;
      direction. The blood circulation brings these chains to the whole body. Based on the lab&#xD;
      results, the blood viscosity along the flow direction will be reduced by 10-20% or more; the&#xD;
      turbulence in blood circulation will be suppressed by the treatment if the subject has&#xD;
      turbulence in the blood circulation. As a result, the blood flow will become laminar and the&#xD;
      blood pressure will be lowered. The above effects will last for about 24 hours after the&#xD;
      treatment and slowly decay. However, re-treatment will bring the effects back. In long term,&#xD;
      the magnetic treatment could prevent development of atherosclerotic plaques in blood vessels.&#xD;
      The effectiveness of the magnetic treatment will be determined by&#xD;
&#xD;
        -  evaluating the reduction of the systolic blood pressure and diastolic blood pressure&#xD;
           immediately after the magnetic treatment;&#xD;
&#xD;
        -  comparing the blood pressure 24 hours after the magnetic treatment with the initial&#xD;
           blood pressure before the magnetic treatment and evaluating any reduction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 10, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 9, 2019</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>
    <intervention_model_description>Subjects in second stage of hypertension: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic devices implanted, will not be admitted.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Blood Pressure at the End of Magnetic Treatment</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measure and evaluate the change of both systolic blood pressure and diastolic blood pressure from the baseline at the end of magnetic treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Blood Pressure 24 Hours after the Magnetic Treatment</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measure and evaluate the change of both systolic blood pressure and diastolic blood pressure from the baseline 24 hours after the magnetic treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Magnetic field treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will place his/her right arm into a bore of the Magnetic Blood Pressure Lowering (MBPL) Device for magnetic treatment of 15 minutes, while the blood pressure is monitored with the left arm. The MBPL device produces a magnetic field around 1T parallel to the blood flow inside the arm. The subject's blood pressure will be lowered. The subject needs to come back to check the blood pressure 24 hours after the treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic field treatment</intervention_name>
    <description>The MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. To start with, the subject's blood pressure is measured first as the baseline. Afterwards, the subject places his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment lasts about 15 minutes and will lower the subject's blood pressure. In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved.</description>
    <arm_group_label>Magnetic field treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in&#xD;
             a range 90-120 mmHg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a pacemaker or other metallic devices implanted.&#xD;
&#xD;
          -  Adults unable to consent,&#xD;
&#xD;
          -  Cognitively impaired adults,&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Prisoners.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rongjia Tao, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular Therapy LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rongjia Tao, Ph.D.</last_name>
    <phone>2152047651</phone>
    <email>rtao@temple.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Magnetic Blood Pressure Lowering Device Study</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongjia Tao</last_name>
      <phone>215-204-7651</phone>
      <email>rtao@temple.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.aps.org/publications/apsnews/201705/magnetic.cfm</url>
    <description>Special Report</description>
  </link>
  <results_reference>
    <citation>Tao R, Huang K. Reducing blood viscosity with magnetic fields. Phys Rev E Stat Nonlin Soft Matter Phys. 2011 Jul;84(1 Pt 1):011905. doi: 10.1103/PhysRevE.84.011905. Epub 2011 Jul 12.</citation>
    <PMID>21867211</PMID>
  </results_reference>
  <results_reference>
    <citation>Tao R, Tang H, Xu X, Tawhid-Al-Islam K, Du E, &quot;Systems and methods for reducing the viscosity of blood, suppressing turbulence in blood circulation, and curing rouleaux&quot; PCT/US2017/059446, WO2018/085330A4</citation>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiovascular Therapy LLC</investigator_affiliation>
    <investigator_full_name>Rongjia Tao</investigator_full_name>
    <investigator_title>Chief Scientist and Chief Counsel</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.facebook.com/Cardiovasculartherapy/?modal=admin_todo_tour</doc_url>
      <doc_comment>After the clinical trials are completed, the clinical study report will be provided upon request via rtao@temple.edu.</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03783117
org study id: 201801
nct id: NCT03783117
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
Heart attacks and strokes are the leading causes of death in US. High blood viscosity and
      turbulence in blood flow are the key for cardiovascular diseases. Recent research has shown
      that application of a strong magnetic field along the blood flow direction will polarize the
      red blood cells and align them into short chains along the flow, so that the blood viscosity
      in the flow direction is reduced significantly and disturbed motions in the directions
      perpendicular to the flow is suppressed. This makes the blood flow laminar, turbulence
      suppressed, and the possibility of cardiac events reduced. Such magnet treatment also cures
      rouleaux and improves the blood's oxygen function. The lab tests also confirm that the above
      effects last more than 24 hours after one treatment.

      The purpose of this trial is to apply this technology to humans. According to the lab tests,
      this magnetic treatment has the potential to bring the following benefits to the subjects:
      (a)The blood viscosity will be reduced by 10-20% or more. (b) The turbulence in blood
      circulation will be suppressed by the treatment. After the treatment, the blood flow will be
      laminar. As a joint effect of viscosity reduction and turbulence suppression, the blood
      pressure will be lowered by 10-20% or more. (c) The subject's blood oxygen function will be
      improved by the treatment. Especially, if the subject has rouleaux in his/her blood, the
      effect will be significant. (d) The above effects will last for about 24 hours after one
      treatment and slowly decay; however, re-treatment will bring the effects back. (e) Because
      steady laminar blood flow is atheroprotective by active reduction of inflammatory genes, the
      magnetic treatment, reducing disturbed blood flow hemodynamics, would be possible to have a
      long term effect as an anti-atherogenic therapy if the treatment keeps for a while.

      The investigators have just completed the pilot clinical trial. The tests confirm that the
      technology is safe and effective in lowering the blood pressure and the effect lasts about 24
      hours. The present pivotal clinical trials are the continuation and expansion of the pilot
      tests. The successful clinical trials will make this technology available for people in
      preventing heart attack and stroke.
GOAL: Conduct pivotal clinical trials with Magnetic Blood Pressure Lowering (MBPL) Device,
      developed in this lab, to see how effective it can lower patients' high blood pressure. The
      pilot study has confirmed the safety and performance of the device. The pivotal tests will
      test a large population of subject with hypertension to determine the effectiveness of the
      MBPL device and check if there is any adverse effect.

      RECRUITMENT: For the pivotal clinical trials, subjects in second stage of hypertension will
      be selected: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood
      pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic
      devices implanted, will not be selected. In addition, any adults unable to consent,
      cognitively impaired adults, and subjects who are not yet adults (infants, children,
      teenagers), pregnant women, and prisoners, will not be admitted.

      STUDY: The MBPL device for clinical trials is made with modification of an electromagnet: A
      bore of 10 cm diameter was made to go through the frame and poles. The device can produce a
      magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial
      for each subject takes about 20-30 minutes. The subject's blood pressure will be measured
      first. Afterwards, the subject will place his/her right arm into the bore of the
      electromagnet for treatment while the blood pressure is monitored with the left arm. The
      magnetic treatment will last about 15 minutes.

      In order to see how long the effect lasts, the subject needs to return and measure the blood
      pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is
      no medicine or surgery involved.

      ANALYSES: During the magnetic treatment, the MBPL device applies a strong magnetic field
      along the blood flow direction in subjects' right arm. Under the magnetic field, the
      deoxygenated red blood cells are polarized and form short chains along the blood flow
      direction. The blood circulation brings these chains to the whole body. Based on the lab
      results, the blood viscosity along the flow direction will be reduced by 10-20% or more; the
      turbulence in blood circulation will be suppressed by the treatment if the subject has
      turbulence in the blood circulation. As a result, the blood flow will become laminar and the
      blood pressure will be lowered. The above effects will last for about 24 hours after the
      treatment and slowly decay. However, re-treatment will bring the effects back. In long term,
      the magnetic treatment could prevent development of atherosclerotic plaques in blood vessels.
      The effectiveness of the magnetic treatment will be determined by

        -  evaluating the reduction of the systolic blood pressure and diastolic blood pressure
           immediately after the magnetic treatment;

        -  comparing the blood pressure 24 hours after the magnetic treatment with the initial
           blood pressure before the magnetic treatment and evaluating any reduction.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects in second stage of hypertension: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic devices implanted, will not be admitted.
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Blood Pressure at the End of Magnetic Treatment
time frame: Through study completion, an average of 1 year
description: Measure and evaluate the change of both systolic blood pressure and diastolic blood pressure from the baseline at the end of magnetic treatment.
measure: Change of Blood Pressure 24 Hours after the Magnetic Treatment
time frame: Through study completion, an average of 1 year
description: Measure and evaluate the change of both systolic blood pressure and diastolic blood pressure from the baseline 24 hours after the magnetic treatment
arm group label: Magnetic field treatment
arm group type: Experimental
description: Each subject will place his/her right arm into a bore of the Magnetic Blood Pressure Lowering (MBPL) Device for magnetic treatment of 15 minutes, while the blood pressure is monitored with the left arm. The MBPL device produces a magnetic field around 1T parallel to the blood flow inside the arm. The subject's blood pressure will be lowered. The subject needs to come back to check the blood pressure 24 hours after the treatment.
intervention type: Device
intervention name: Magnetic field treatment
description: The MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. To start with, the subject's blood pressure is measured first as the baseline. Afterwards, the subject places his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment lasts about 15 minutes and will lower the subject's blood pressure. In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved.
arm group label: Magnetic field treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rongjia Tao, Ph.D.
role: Principal Investigator
affiliation: Cardiovascular Therapy LLC
last name: Rongjia Tao, Ph.D.
phone: 2152047651
email: rtao@temple.edu
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.aps.org/publications/apsnews/201705/magnetic.cfm
description: Special Report
citation: Tao R, Huang K. Reducing blood viscosity with magnetic fields. Phys Rev E Stat Nonlin Soft Matter Phys. 2011 Jul;84(1 Pt 1):011905. doi: 10.1103/PhysRevE.84.011905. Epub 2011 Jul 12.
PMID: 21867211
citation: Tao R, Tang H, Xu X, Tawhid-Al-Islam K, Du E, "Systems and methods for reducing the viscosity of blood, suppressing turbulence in blood circulation, and curing rouleaux" PCT/US2017/059446, WO2018/085330A4
responsible party type: Principal Investigator
investigator affiliation: Cardiovascular Therapy LLC
investigator full name: Rongjia Tao
investigator title: Chief Scientist and Chief Counsel
mesh term: Hypertension
mesh term: Hypotension
sharing ipd: No
study doc: 