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/NCT05977725</url>
    </required_header>
    <id_info>
      <org_study_id>1 - VASC - 2023</org_study_id>
      <nct_id>NCT05977725</nct_id>
    </id_info>
    <brief_title>Hand Acceleration Time Assessment With Ultrasound Doppler</brief_title>
    <acronym>HAT</acronym>
    <official_title>Hemodynamic Assessment of the Hand Arterial Perfusion Through the Ultrasound-Doppler Hand Acceleration Time (HAT) Technique: A Descriptive Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Universitari de Bellvitge</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Universitari de Bellvitge</source>
    <oversight_info>
      <has_dmc>No</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>
        Chronic upper limb ischemia syndrome is uncommon compared to lower limb ischemia, with&#xD;
        several potential causes (e.g., arteriosclerosis, compressive syndromes, arteritis,&#xD;
        connective tissue diseases, trauma, and thrombosis). Many patients with upper limb ischemia&#xD;
        remain asymptomatic due to arterial collateral vascularization.&#xD;
  &#xD;
        Given the wide variety of potential causes for upper limb ischemia, the diagnosis may require&#xD;
        different technical approaches. Doppler ultrasound is a non-invasive, accessible,&#xD;
        non-radiating technique that provides direct arterial imaging, yielding valuable information&#xD;
        on arterial anatomy and hemodynamics.&#xD;
  &#xD;
        Some authors have described the reliability of the arterial duplex ultrasound for lower limb&#xD;
        assessment using the pedal acceleration time (PAT). The PAT provides real-time hemodynamic&#xD;
        physiological information on the entire limb. The acceleration time (AT) is an ultrasound&#xD;
        parameter which measures the time elapsed (in milliseconds, ms) from the beginning of the&#xD;
        arterial Doppler waveform until the systolic peak, evaluating the morphology of the arterial&#xD;
        waveform in real time. In a healthy individual, this time should be short (between 40 - 100&#xD;
        milliseconds), displaying a triphasic waveform with a systolic acceleration, a sudden&#xD;
        diastolic fall, and a subsequent anterograde flow at the end of diastole. A more damped wave&#xD;
        suggests proximal stenosis and the acceleration time has been correlated to different degrees&#xD;
        of foot ischemia.&#xD;
  &#xD;
        Notably, the AT parameter has also been studied in other territories, such as the carotid and&#xD;
        pulmonary arteries, coronary arteries, and the aorta. Hand acceleration time (HAT) has also&#xD;
        been described very recently as a potential tool to assess hemodialysis access-induced&#xD;
        ischemia, cardiogenic shock, and subclavian iatrogenic ischemic lesion. However, the HAT has&#xD;
        not yet been properly characterized or validated. Our working hypothesis is that the HAT is a&#xD;
        useful diagnostic tool for chronic upper limb ischemia.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Median (range) hand acceleration time measured by Doppler ultrasound</measure>
      <time_frame>Day 1</time_frame>
      <description>The hand acceleration time will be measured at the following arteries:&#xD;
  Distal radial artery&#xD;
  Distal ulnar artery&#xD;
  Princeps pollicis artery&#xD;
  Index finger radial artery&#xD;
  Second common palmar digital artery&#xD;
  Fourth common palmar digital artery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Median (range) age of the participants.</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number (percentage) of male/female participants.</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number (percentage) of patients presenting cardiovascular risk factors of interest.</measure>
      <time_frame>Day 1</time_frame>
      <description>Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number (percentage) of patients with past medical history of interest.</measure>
      <time_frame>Day 1</time_frame>
      <description>A past medical history of interest is defined as ischemic cardiopathy, heart failure, and chronic obstructive pulmonary disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence (Yes/No) of distal pulses in the upper limb.</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Upper Limb Ischemia</condition>
    <condition>Vascular Disease</condition>
    <arm_group>
      <arm_group_label>Healthy Volunteers</arm_group_label>
      <description>Lack of upper limb arterial disease.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with Chronic Upper Limb Ischemia</arm_group_label>
      <description>Known diagnosis of chronic upper limb ischemia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Hand Doppler Ultrasound</intervention_name>
      <description>Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)</description>
      <arm_group_label>Healthy Volunteers</arm_group_label>
      <arm_group_label>Patients with Chronic Upper Limb Ischemia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will consist of healthy volunteers accompanying patients to the&#xD;
          Angiology and Vascular Surgery outpatient clinic visit and patients diagnosed with chronic&#xD;
          upper limb ischemia. Both will be required to sign the written informed consent before&#xD;
          joining the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria (healthy volunteers):&#xD;
  &#xD;
            -  Healthy adult volunteers (≥ 18 years of age).&#xD;
  &#xD;
            -  No evidence of upper limb arterial disease.&#xD;
  &#xD;
            -  Who sign the written informed consent.&#xD;
  &#xD;
          Exclusion Criteria (healthy volunteers):&#xD;
  &#xD;
            -  Healthy volunteers unable (at the investigator discretion) to understand or comply&#xD;
               with any study-related procedure.&#xD;
  &#xD;
            -  Healthy volunteers who refuse to participate.&#xD;
  &#xD;
            -  Those presenting cardiovascular risk factors (e.g., hypertension, diabetes mellitus,&#xD;
               dyslipidemia).&#xD;
  &#xD;
          Inclusion Criteria (upper limb ischemia patients):&#xD;
  &#xD;
            -  Adult patients (≥ 18 years of age) with a known diagnosis of chronic upper limb&#xD;
               ischemia.&#xD;
  &#xD;
            -  Who sign the written informed consent.&#xD;
  &#xD;
          Exclusion Criteria (upper limb ischemia patients):&#xD;
  &#xD;
            -  Patients unable (at the investigator discretion) to understand or comply with any&#xD;
               study-related procedure.&#xD;
  &#xD;
            -  Patients who refuse to participate.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Begoña Gonzalo, MD</last_name>
      <phone>+34932607323</phone>
      <email>bgonzalo@bellvitgehospital.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sebastián Videla, MD, PhD</last_name>
      <phone>+34609072420</phone>
      <email>svidela@bellvitgehospital.cat</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Universitari de Bellvitge</name>
        <address>
          <city>L'Hospitalet De Llobregat</city>
          <state>Barcelona</state>
          <zip>08907</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Begoña Gonzalo, MD</last_name>
        <phone>+34932607323</phone>
        <email>bgonzalo@bellvitgehospital.cat</email>
      </contact>
      <contact_backup>
        <last_name>Sebastián Videla, MD, PhD</last_name>
        <phone>+34609072420</phone>
        <email>svidela@bellvitgehospital.cat</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Sommerset J, Karmy-Jones R, Dally M, Feliciano B, Vea Y, Teso D. Plantar Acceleration Time: A Novel Technique to Evaluate Arterial Flow to the Foot. Ann Vasc Surg. 2019 Oct;60:308-314. doi: 10.1016/j.avsg.2019.03.002. Epub 2019 May 8.</citation>
      <PMID>31075481</PMID>
    </reference>
    <reference>
      <citation>Teso D, Sommerset J, Dally M, Feliciano B, Vea Y, Jones RK. Pedal Acceleration Time (PAT): A Novel Predictor of Limb Salvage. Ann Vasc Surg. 2021 Aug;75:189-193. doi: 10.1016/j.avsg.2021.02.038. Epub 2021 Apr 3.</citation>
      <PMID>33823258</PMID>
    </reference>
    <reference>
      <citation>Strosberg DS, Haurani MJ, Satiani B, Go MR. Common carotid artery end-diastolic velocity and acceleration time can predict degree of internal carotid artery stenosis. J Vasc Surg. 2017 Jul;66(1):226-231. doi: 10.1016/j.jvs.2017.01.041. Epub 2017 Apr 5.</citation>
      <PMID>28390773</PMID>
    </reference>
    <reference>
      <citation>Wang S, Wang Y, Gao M, Tan Y. Acceleration time to Ejection time ratio in fetal pulmonary artery system can predict neonatal respiratory disorders in gestational diabetic mellitus women. Clin Hemorheol Microcirc. 2022;80(4):497-507. doi: 10.3233/CH-211265.</citation>
      <PMID>34924370</PMID>
    </reference>
    <reference>
      <citation>Takemoto K, Hirata K, Wada N, Shiono Y, Komukai K, Tanimoto T, Ino Y, Kitabata H, Takarada S, Nakamura N, Kubo T, Tanaka A, Imanishi T, Akasaka T. Acceleration time of systolic coronary flow velocity to diagnose coronary stenosis in patients with microvascular dysfunction. J Am Soc Echocardiogr. 2014 Feb;27(2):200-7. doi: 10.1016/j.echo.2013.10.013. Epub 2013 Dec 15.</citation>
      <PMID>24345631</PMID>
    </reference>
    <reference>
      <citation>Zarzecki MP, Popieluszko P, Zayachkowski A, Pekala PA, Henry BM, Tomaszewski KA. The surgical anatomy of the superficial and deep palmar arches: A Meta-analysis. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1577-1592. doi: 10.1016/j.bjps.2018.08.014. Epub 2018 Aug 24.</citation>
      <PMID>30245020</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
      <investigator_full_name>Begoña Gonzalo Villanueva</investigator_full_name>
      <investigator_title>Expert Vascular Surgeon</investigator_title>
    </responsible_party>
    <keyword>Hand acceleration time</keyword>
    <keyword>Upper limb ischemia</keyword>
    <keyword>Vascular disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vascular Diseases</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <!-- 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/NCT05977725
  org study id: 1 - VASC - 2023
  nct id: NCT05977725
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic upper limb ischemia syndrome is uncommon compared to lower limb ischemia, with
        several potential causes (e.g., arteriosclerosis, compressive syndromes, arteritis,
        connective tissue diseases, trauma, and thrombosis). Many patients with upper limb ischemia
        remain asymptomatic due to arterial collateral vascularization.
  
        Given the wide variety of potential causes for upper limb ischemia, the diagnosis may require
        different technical approaches. Doppler ultrasound is a non-invasive, accessible,
        non-radiating technique that provides direct arterial imaging, yielding valuable information
        on arterial anatomy and hemodynamics.
  
        Some authors have described the reliability of the arterial duplex ultrasound for lower limb
        assessment using the pedal acceleration time (PAT). The PAT provides real-time hemodynamic
        physiological information on the entire limb. The acceleration time (AT) is an ultrasound
        parameter which measures the time elapsed (in milliseconds, ms) from the beginning of the
        arterial Doppler waveform until the systolic peak, evaluating the morphology of the arterial
        waveform in real time. In a healthy individual, this time should be short (between 40 - 100
        milliseconds), displaying a triphasic waveform with a systolic acceleration, a sudden
        diastolic fall, and a subsequent anterograde flow at the end of diastole. A more damped wave
        suggests proximal stenosis and the acceleration time has been correlated to different degrees
        of foot ischemia.
  
        Notably, the AT parameter has also been studied in other territories, such as the carotid and
        pulmonary arteries, coronary arteries, and the aorta. Hand acceleration time (HAT) has also
        been described very recently as a potential tool to assess hemodialysis access-induced
        ischemia, cardiogenic shock, and subclavian iatrogenic ischemic lesion. However, the HAT has
        not yet been properly characterized or validated. Our working hypothesis is that the HAT is a
        useful diagnostic tool for chronic upper limb ischemia.
  observational model: Other
  time perspective: Prospective
  measure: Median (range) hand acceleration time measured by Doppler ultrasound
  time frame: Day 1
  description: The hand acceleration time will be measured at the following arteries:
  Distal radial artery
  Distal ulnar artery
  Princeps pollicis artery
  Index finger radial artery
  Second common palmar digital artery
  Fourth common palmar digital artery
  measure: Median (range) age of the participants.
  time frame: Day 1
  measure: Number (percentage) of male/female participants.
  time frame: Day 1
  measure: Number (percentage) of patients presenting cardiovascular risk factors of interest.
  time frame: Day 1
  description: Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia).
  measure: Number (percentage) of patients with past medical history of interest.
  time frame: Day 1
  description: A past medical history of interest is defined as ischemic cardiopathy, heart failure, and chronic obstructive pulmonary disease.
  measure: Presence (Yes/No) of distal pulses in the upper limb.
  time frame: Day 1
  arm group label: Healthy Volunteers
  description: Lack of upper limb arterial disease.
  arm group label: Patients with Chronic Upper Limb Ischemia
  description: Known diagnosis of chronic upper limb ischemia.
  intervention type: Diagnostic Test
  intervention name: Hand Doppler Ultrasound
  description: Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)
  arm group label: Healthy Volunteers
  arm group label: Patients with Chronic Upper Limb Ischemia
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Begoña Gonzalo, MD
  phone: +34932607323
  email: bgonzalo@bellvitgehospital.cat
  last name: Sebastián Videla, MD, PhD
  phone: +34609072420
  email: svidela@bellvitgehospital.cat
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Spain
  citation: Sommerset J, Karmy-Jones R, Dally M, Feliciano B, Vea Y, Teso D. Plantar Acceleration Time: A Novel Technique to Evaluate Arterial Flow to the Foot. Ann Vasc Surg. 2019 Oct;60:308-314. doi: 10.1016/j.avsg.2019.03.002. Epub 2019 May 8.
  PMID: 31075481
  citation: Teso D, Sommerset J, Dally M, Feliciano B, Vea Y, Jones RK. Pedal Acceleration Time (PAT): A Novel Predictor of Limb Salvage. Ann Vasc Surg. 2021 Aug;75:189-193. doi: 10.1016/j.avsg.2021.02.038. Epub 2021 Apr 3.
  PMID: 33823258
  citation: Strosberg DS, Haurani MJ, Satiani B, Go MR. Common carotid artery end-diastolic velocity and acceleration time can predict degree of internal carotid artery stenosis. J Vasc Surg. 2017 Jul;66(1):226-231. doi: 10.1016/j.jvs.2017.01.041. Epub 2017 Apr 5.
  PMID: 28390773
  citation: Wang S, Wang Y, Gao M, Tan Y. Acceleration time to Ejection time ratio in fetal pulmonary artery system can predict neonatal respiratory disorders in gestational diabetic mellitus women. Clin Hemorheol Microcirc. 2022;80(4):497-507. doi: 10.3233/CH-211265.
  PMID: 34924370
  citation: Takemoto K, Hirata K, Wada N, Shiono Y, Komukai K, Tanimoto T, Ino Y, Kitabata H, Takarada S, Nakamura N, Kubo T, Tanaka A, Imanishi T, Akasaka T. Acceleration time of systolic coronary flow velocity to diagnose coronary stenosis in patients with microvascular dysfunction. J Am Soc Echocardiogr. 2014 Feb;27(2):200-7. doi: 10.1016/j.echo.2013.10.013. Epub 2013 Dec 15.
  PMID: 24345631
  citation: Zarzecki MP, Popieluszko P, Zayachkowski A, Pekala PA, Henry BM, Tomaszewski KA. The surgical anatomy of the superficial and deep palmar arches: A Meta-analysis. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1577-1592. doi: 10.1016/j.bjps.2018.08.014. Epub 2018 Aug 24.
  PMID: 30245020
  responsible party type: Principal Investigator
  investigator affiliation: Hospital Universitari de Bellvitge
  investigator full name: Begoña Gonzalo Villanueva
  investigator title: Expert Vascular Surgeon
  mesh term: Vascular Diseases
  mesh term: Ischemia