<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/NCT03243968</url>
  </required_header>
  <id_info>
    <org_study_id>Biovasc isquêmicos</org_study_id>
    <nct_id>NCT03243968</nct_id>
  </id_info>
  <brief_title>Endothelial and Microvascular Functions in Patients With Myocardial Ischemia</brief_title>
  <official_title>Evaluation of Endothelial and Microvascular Functions in Patients With Myocardial Ischemia Detected by Scintilography and Normal Coronariography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rio de Janeiro State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Camillo L.C. Junqueira</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Esmeralci Ferreira</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maria das Graças C. Souza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eliete Bouskela</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rio de Janeiro State University</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>
      Cardiovascular diseases (CVD) are responsible, throughout the world, for high mortality rates&#xD;
      and cardiovascular morbidity. Endothelial dysfunction is the earliest marker of clinical&#xD;
      atherosclerosis development. Human studies show that endothelial and microvascular&#xD;
      dysfunction are independent predictors of ischemic cardiovascular events and long-term&#xD;
      prognosis. The study´s objective is to evaluate the endothelial and peripheral&#xD;
      microcirculation changes by venous occlusion plethysmography (VOP),&#xD;
      nailfoldvideocapillaroscopy (NVC) and serum biomarkers in patients with myocardial ischemia&#xD;
      detected by scintigraphy and normal coronarography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cross-sectional study was carried out with 50 participants: 25 with myocardial ischemia&#xD;
      detected by scintigraphy and normal coronarography (Ischemic Patient - IP) and 25 healthy&#xD;
      non-ischemic individuals (Control Group - CG). All of them were submitted to anamnesis, serum&#xD;
      markers (Intercellular Cell Adhesion Molecule [ICAM], Vascular Cell Adhesion Molecule[VCAM],&#xD;
      adiponectin, endothelin, LDL-oxidized and CRP-US), NVC and VOP. Exclusion criteria were:&#xD;
      inflammatory diseases, cancer patients, recent traumas, Diabetes Mellitus, obese individuals&#xD;
      with BMI&gt; 35 kg/m², uncontrolled hypertensive patients, and those with active infectious&#xD;
      processes. In the NVC,capillary diameters were observed, as well as red blood cells velocity&#xD;
      in the capillaries (RBCV, mm/s), maximum red blood cells after 1 minute ischemia (RBCVmax,&#xD;
      mm/s) and time to reach maximal velocity (TRBCVmax) and, regarding VOP,the baseline blood&#xD;
      flow (ml/min), post 5 minute ischemia flow and vascular resistance (mmHg/ml/min) were&#xD;
      evaluated. Data were analyzed using Student's t-tests for independent or Mann-Whitney&#xD;
      samples; χ2 or Fisher exact. The absolute and relative variations (delta) of plethysmography&#xD;
      measurements versus baseline in each group were analyzed by the Wilcoxon signed-ranks test&#xD;
      and compared between the groups by the Mann-Whitney test. For correction of confounding&#xD;
      factors, age and BMI, it was used Covariance Analysis (ANCOVA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">August 30, 2015</completion_date>
  <primary_completion_date type="Actual">August 30, 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>%Hyper</measure>
    <time_frame>One year</time_frame>
    <description>Increment of forearm blood flow during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intercellular adhesion molecule (ICAM)</measure>
    <time_frame>One year</time_frame>
    <description>Inflammatory biomarker obtained through withdrawal of venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular adhesion molecule (VCAM)</measure>
    <time_frame>One year</time_frame>
    <description>Inflammatory biomarker obtained through withdrawal of venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiponectin</measure>
    <time_frame>One year</time_frame>
    <description>Adipokyne obtained through withdrawal of venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelin</measure>
    <time_frame>One year</time_frame>
    <description>Potent vasoconstrictor obtained through withdrawal of venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-oxidized</measure>
    <time_frame>One year</time_frame>
    <description>Low density lipoprotein oxidized used to measure oxidative stress. It is obtained from venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>One year</time_frame>
    <description>C reactive protein obtained through withdrawal of venous blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Nitro</measure>
    <time_frame>One year</time_frame>
    <description>Increment of forearm blood flow after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FCD</measure>
    <time_frame>One year</time_frame>
    <description>Functional capillary density. Number of capillaries with flowing red blood cell in microscope area. Obtained from Nailfold videocapillaroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AFCD</measure>
    <time_frame>One year</time_frame>
    <description>Afferent capillar diameter. Obtained from Nailfold videocapillaroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACD</measure>
    <time_frame>One year</time_frame>
    <description>Apical capillar diameter. Obtained from Nailfold videocapillaroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EFCD</measure>
    <time_frame>One year</time_frame>
    <description>Efferent capillar diameter. Obtained from Nailfold videocapillaroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RBCV</measure>
    <time_frame>One year</time_frame>
    <description>Basal red blood cell velocity. Obtained from Nailfold videocapillaroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RBCVmax</measure>
    <time_frame>One year</time_frame>
    <description>Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TRBCVmax</measure>
    <time_frame>One year</time_frame>
    <description>Time to reach Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%ResHyper</measure>
    <time_frame>One year</time_frame>
    <description>Increment of vascular resistance during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%ResNitro</measure>
    <time_frame>One year</time_frame>
    <description>Increment of vascular resistance after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Microcirculation; Biomarkers; Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>Ischemic patient - IP</arm_group_label>
    <description>25 participants with myocardial ischemia detected by scintigraphy and normal coronarography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group - CG</arm_group_label>
    <description>25 healthy non-ischemic individuals</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Fifty patients were studied: 39% male and 61% female. The mean age was 48 ± 15.8 years,&#xD;
        being: 56.5 ± 10.5 years in the IP group and 39.4 ± 15.8 years in the CG. The mean BMI was&#xD;
        26.5 ± 4.30 kg/m².&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The study population consisted of 50 patients of both sexes, stratified into two groups:&#xD;
        patients with myocardial ischemia detected by scintigraphy (group IP, n = 25) and healthy&#xD;
        individuals (CG group, n = 25). In the patients who underwent scintigraphy with tomographic&#xD;
        sections and presented any type of image attenuation during the examination, they also&#xD;
        underwent a complementary prone position technique. Patients without these characteristics&#xD;
        scintigraphy methodologies were excluded from the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria were adopted: patients with type 1 or 2 Diabetes Mellitus, heart&#xD;
        failure, myocardial infarction or brain stroke with less than three months of the event,&#xD;
        chronic renal disease, users of hormonal or non-hormonal anti-inflammatory drugs, recent&#xD;
        trauma (less than three months) autoimmune diseases, active infectious processes, presence&#xD;
        of neoplasia, use of Aspirin (anti-inflammatory dose), obesity with BMI&gt;35 kg/m²,&#xD;
        uncontrolled hypertensive patients, resistant hypertensives, and non-compliance in the&#xD;
        examinations or with the signature of the Consent Form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rio de Janeiro State University</investigator_affiliation>
    <investigator_full_name>Daniel Alexandre Bottino</investigator_full_name>
    <investigator_title>MD and PHD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03243968
org study id: Biovasc isquêmicos
nct id: NCT03243968
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular diseases (CVD) are responsible, throughout the world, for high mortality rates
      and cardiovascular morbidity. Endothelial dysfunction is the earliest marker of clinical
      atherosclerosis development. Human studies show that endothelial and microvascular
      dysfunction are independent predictors of ischemic cardiovascular events and long-term
      prognosis. The study´s objective is to evaluate the endothelial and peripheral
      microcirculation changes by venous occlusion plethysmography (VOP),
      nailfoldvideocapillaroscopy (NVC) and serum biomarkers in patients with myocardial ischemia
      detected by scintigraphy and normal coronarography.
A cross-sectional study was carried out with 50 participants: 25 with myocardial ischemia
      detected by scintigraphy and normal coronarography (Ischemic Patient - IP) and 25 healthy
      non-ischemic individuals (Control Group - CG). All of them were submitted to anamnesis, serum
      markers (Intercellular Cell Adhesion Molecule [ICAM], Vascular Cell Adhesion Molecule[VCAM],
      adiponectin, endothelin, LDL-oxidized and CRP-US), NVC and VOP. Exclusion criteria were:
      inflammatory diseases, cancer patients, recent traumas, Diabetes Mellitus, obese individuals
      with BMI> 35 kg/m², uncontrolled hypertensive patients, and those with active infectious
      processes. In the NVC,capillary diameters were observed, as well as red blood cells velocity
      in the capillaries (RBCV, mm/s), maximum red blood cells after 1 minute ischemia (RBCVmax,
      mm/s) and time to reach maximal velocity (TRBCVmax) and, regarding VOP,the baseline blood
      flow (ml/min), post 5 minute ischemia flow and vascular resistance (mmHg/ml/min) were
      evaluated. Data were analyzed using Student's t-tests for independent or Mann-Whitney
      samples; χ2 or Fisher exact. The absolute and relative variations (delta) of plethysmography
      measurements versus baseline in each group were analyzed by the Wilcoxon signed-ranks test
      and compared between the groups by the Mann-Whitney test. For correction of confounding
      factors, age and BMI, it was used Covariance Analysis (ANCOVA).
observational model: Other
time perspective: Cross-Sectional
measure: %Hyper
time frame: One year
description: Increment of forearm blood flow during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.
measure: Intercellular adhesion molecule (ICAM)
time frame: One year
description: Inflammatory biomarker obtained through withdrawal of venous blood.
measure: Vascular adhesion molecule (VCAM)
time frame: One year
description: Inflammatory biomarker obtained through withdrawal of venous blood.
measure: Adiponectin
time frame: One year
description: Adipokyne obtained through withdrawal of venous blood.
measure: Endothelin
time frame: One year
description: Potent vasoconstrictor obtained through withdrawal of venous blood.
measure: LDL-oxidized
time frame: One year
description: Low density lipoprotein oxidized used to measure oxidative stress. It is obtained from venous blood.
measure: CRP
time frame: One year
description: C reactive protein obtained through withdrawal of venous blood.
measure: % Nitro
time frame: One year
description: Increment of forearm blood flow after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography..
measure: FCD
time frame: One year
description: Functional capillary density. Number of capillaries with flowing red blood cell in microscope area. Obtained from Nailfold videocapillaroscopy.
measure: AFCD
time frame: One year
description: Afferent capillar diameter. Obtained from Nailfold videocapillaroscopy.
measure: ACD
time frame: One year
description: Apical capillar diameter. Obtained from Nailfold videocapillaroscopy.
measure: EFCD
time frame: One year
description: Efferent capillar diameter. Obtained from Nailfold videocapillaroscopy.
measure: RBCV
time frame: One year
description: Basal red blood cell velocity. Obtained from Nailfold videocapillaroscopy.
measure: RBCVmax
time frame: One year
description: Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.
measure: TRBCVmax
time frame: One year
description: Time to reach Maximum red blood cell velocity during reactive hyperemia in fourth finger after one minute ischemia. Obtained from Nailfold videocapillaroscopy.
measure: %ResHyper
time frame: One year
description: Increment of vascular resistance during reactive hyperemia after 5 minutes arm ischemia with venous occlusion plethysmography.
measure: %ResNitro
time frame: One year
description: Increment of vascular resistance after 5 minutes of 400 μg sublingual nitroglycerin application with venous occlusion plethysmography.
arm group label: Ischemic patient - IP
description: 25 participants with myocardial ischemia detected by scintigraphy and normal coronarography
arm group label: Control group - CG
description: 25 healthy non-ischemic individuals
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Rio de Janeiro State University
investigator full name: Daniel Alexandre Bottino
investigator title: MD and PHD
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Ischemia
sharing ipd: No