<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/NCT02264509</url>
  </required_header>
  <id_info>
    <org_study_id>InstitutoNCMNSZ-CIIBH693</org_study_id>
    <nct_id>NCT02264509</nct_id>
  </id_info>
  <brief_title>Peripheral Arterial Insufficiency Associated With HIV/AIDS</brief_title>
  <acronym>AIHIV</acronym>
  <official_title>Prevalence and Risk Factors of Arterial Insufficiency in Patients With HIV / AIDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the risk factors associated with the occurrence of&#xD;
      arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this&#xD;
      disease. The estimated prevalence is 10%, similar to that reported in the general population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A case study nested in a cohort of patients with HIV / AIDS at Instituto Nacional de Ciencias&#xD;
      Médicas y Nutrición Salvador Zubirán, Mexico, with a cohort of 1500 patients , a sample size&#xD;
      of 206 individuals was calculated. Data collection was performed in a prospective cross&#xD;
      shape.&#xD;
&#xD;
      During the interview, written informed consent for inclusion in the study, along with a&#xD;
      standard query of vascular surgery in which the patient's history as well as cardiovascular&#xD;
      risk factors. Also, a vascular physical examination including palpation of pulses in upper&#xD;
      and lower extremities (brachial, radial, ulnar, femoral, popliteal, posterior tibial and&#xD;
      dorsalis pedis), femoral murmurs search and determining ankle / brachial indexes with a&#xD;
      standardized method.&#xD;
&#xD;
      In determining the ABI was counted with a Doppler ultrasound 8 mHz, transducer gel and a&#xD;
      sleeve for manual measurement of blood pressure, 20% longer than the largest diameter of the&#xD;
      arm circumference.&#xD;
&#xD;
      If the patient is diagnosed with, symptomatic or asymptomatic arterial insufficiency, ABI&#xD;
      measurements were performed at rest and effort, plus pressure index finger-arm or&#xD;
      plethysmography. Patients with altered rates were followed in vascular surgery care.&#xD;
&#xD;
      The data were recorded in a single database unique protected by password. The results were&#xD;
      analyzed using the statistical program STATA v 9.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Arterial insufficiency</measure>
    <time_frame>1 time</time_frame>
    <description>Arterial insufficiency is measured by Ankle / brachial index described as ABI&lt;0.9 or ABI &gt;1.2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gender</measure>
    <time_frame>1 time</time_frame>
    <description>Male or Female</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>1 time</time_frame>
    <description>Number of years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes mellitus</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypercholesterolemia</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertriglyceridemia</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoalphalipoproteinemia</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension (High blood pressure)</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as diagnosis in previous notes or use of antihypertensives.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ischemic heart disease</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as previous heart attack.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as previous diagnosis in the record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking</measure>
    <time_frame>1 time</time_frame>
    <description>Smoking yes or no.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking index</measure>
    <time_frame>1 time</time_frame>
    <description>Smoking index defined as the number of cigarettes smoked per day by the number of years of smoking divided by 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug abuse</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as use or history of use of drugs of abuse investigated during the interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AIDS</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Time of HIV</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Load</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as the last number of copies of certain virus in patient serum in the record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as the final determination of number of CD4 in serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAART (Highly active anti-retroviral therapy)</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as use of at least one drug with anti-retroviral activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time HAART</measure>
    <time_frame>1 TIME</time_frame>
    <description>Defined as a period in months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HIV</measure>
    <time_frame>1 time</time_frame>
    <description>Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">206</enrollment>
  <condition>Arterial Insufficiency</condition>
  <condition>Acquired Immunodeficiency Syndrome</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Arterial insufficiency and HIV</arm_group_label>
    <description>Of a cohort of 206 HIV patients will be randomly selected 206 for Ankle-brachial index to identify wich suffer symptomatic or asymptomatic arterial insufficiency</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ankle-Brachial index</intervention_name>
    <description>The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.</description>
    <arm_group_label>Arterial insufficiency and HIV</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The 206 patients will be randomly selected from the cohort HIV / AIDS INCMNSZ, which have&#xD;
        confirmed diagnosis of the disease and wish to participate in the study, without a disease&#xD;
        that put life in imminent danger.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with HIV / AIDS are included in active consultation of Infectious Diseases&#xD;
             INCMNSZ and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not wish to participate in the study and those who did not complete&#xD;
             their interview and vascular physical examination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos A. Hinojosa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana Elsa Núñez Salgado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Jael del C. Ortiz López, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaime Omar Herrera Cáceres, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brenda E. Crabtree Ramirez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Sierra Madero, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>MExico city</city>
        <state>D.F., Mexico</state>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 28, 2016</last_update_submitted>
  <last_update_submitted_qc>January 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</investigator_affiliation>
    <investigator_full_name>Carlos Hinojosa</investigator_full_name>
    <investigator_title>subdirector of clinical research</investigator_title>
  </responsible_party>
  <keyword>Arterial Insufficiency</keyword>
  <keyword>Human Immunodeficiency Virus</keyword>
  <keyword>Atherosclerosis</keyword>
  <keyword>Ankle-brachial index</keyword>
  <keyword>HAART</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</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/NCT02264509
org study id: InstitutoNCMNSZ-CIIBH693
nct id: NCT02264509
lead sponsor: 
has dmc: No
The purpose of this study is to determine the risk factors associated with the occurrence of
      arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this
      disease. The estimated prevalence is 10%, similar to that reported in the general population.
A case study nested in a cohort of patients with HIV / AIDS at Instituto Nacional de Ciencias
      Médicas y Nutrición Salvador Zubirán, Mexico, with a cohort of 1500 patients , a sample size
      of 206 individuals was calculated. Data collection was performed in a prospective cross
      shape.

      During the interview, written informed consent for inclusion in the study, along with a
      standard query of vascular surgery in which the patient's history as well as cardiovascular
      risk factors. Also, a vascular physical examination including palpation of pulses in upper
      and lower extremities (brachial, radial, ulnar, femoral, popliteal, posterior tibial and
      dorsalis pedis), femoral murmurs search and determining ankle / brachial indexes with a
      standardized method.

      In determining the ABI was counted with a Doppler ultrasound 8 mHz, transducer gel and a
      sleeve for manual measurement of blood pressure, 20% longer than the largest diameter of the
      arm circumference.

      If the patient is diagnosed with, symptomatic or asymptomatic arterial insufficiency, ABI
      measurements were performed at rest and effort, plus pressure index finger-arm or
      plethysmography. Patients with altered rates were followed in vascular surgery care.

      The data were recorded in a single database unique protected by password. The results were
      analyzed using the statistical program STATA v 9.0.
observational model: Cohort
time perspective: Prospective
measure: Arterial insufficiency
time frame: 1 time
description: Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2
measure: Gender
time frame: 1 time
description: Male or Female
measure: Age
time frame: 1 time
description: Number of years
measure: Diabetes mellitus
time frame: 1 time
description: Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.
measure: Hypercholesterolemia
time frame: 1 time
description: Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.
measure: Hypertriglyceridemia
time frame: 1 time
description: Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.
measure: Hypoalphalipoproteinemia
time frame: 1 time
description: Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.
measure: Hypertension (High blood pressure)
time frame: 1 time
description: Defined as diagnosis in previous notes or use of antihypertensives.
measure: Ischemic heart disease
time frame: 1 time
description: Defined as previous heart attack.
measure: Stroke
time frame: 1 time
description: Defined as previous diagnosis in the record.
measure: Smoking
time frame: 1 time
description: Smoking yes or no.
measure: Smoking index
time frame: 1 time
description: Smoking index defined as the number of cigarettes smoked per day by the number of years of smoking divided by 20.
measure: Drug abuse
time frame: 1 time
description: Defined as use or history of use of drugs of abuse investigated during the interview
measure: AIDS
time frame: 1 time
description: Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses
measure: Diagnostic Time of HIV
time frame: 1 time
description: Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.
measure: Viral Load
time frame: 1 time
description: Defined as the last number of copies of certain virus in patient serum in the record.
measure: CD4
time frame: 1 time
description: Defined as the final determination of number of CD4 in serum.
measure: HAART (Highly active anti-retroviral therapy)
time frame: 1 time
description: Defined as use of at least one drug with anti-retroviral activity.
measure: Time HAART
time frame: 1 TIME
description: Defined as a period in months
measure: HIV
time frame: 1 time
description: Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)
arm group label: Arterial insufficiency and HIV
description: Of a cohort of 206 HIV patients will be randomly selected 206 for Ankle-brachial index to identify wich suffer symptomatic or asymptomatic arterial insufficiency
intervention type: Procedure
intervention name: Ankle-Brachial index
description: The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.
arm group label: Arterial insufficiency and HIV
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Carlos A. Hinojosa, MD
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Ana Elsa Núñez Salgado, MD
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Laura Jael del C. Ortiz López, MD
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Jaime Omar Herrera Cáceres, MD
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Brenda E. Crabtree Ramirez, MD
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Juan Sierra Madero, MD
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
investigator full name: Carlos Hinojosa
investigator title: subdirector of clinical research
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes