<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/NCT02195388</url>
  </required_header>
  <id_info>
    <org_study_id>FOREVER-1</org_study_id>
    <nct_id>NCT02195388</nct_id>
  </id_info>
  <brief_title>Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System</brief_title>
  <acronym>FOREVER</acronym>
  <official_title>Phase 1 Study - Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System improVement in Patients After MI With or Without hypErtension After Cardiovascular Rehabilitation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lodz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lodz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Myocardial infarction is related with endothelial function, arterial stiffness and autonomic&#xD;
      nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is&#xD;
      also related with endothelial function, arterial stiffness and autonomic nervous system&#xD;
      dysfunction.&#xD;
&#xD;
      Primary aim of study is to investigate how complex cardiac rehabilitation influence&#xD;
      endothelial function, arterial stiffness and autonomic nervous system activity according to&#xD;
      presence or absence arterial hypertension.&#xD;
&#xD;
      Secondary aim is to obtain correlation between methods for the assessment of particular&#xD;
      disorders and intercorrelation between different disorders for example endothelial function&#xD;
      and autonomic nervous system activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We expect that in study groups PWV will improve better that in control group. 5% of the limit&#xD;
      value of p &lt;0.05.&#xD;
&#xD;
      We expect that in study groups AASI will improve better that in control group. 5% of the&#xD;
      limit value of p &lt;0.05.&#xD;
&#xD;
      We expect that in study groups AI will improve better that in control group. 5% of the limit&#xD;
      value of p &lt;0.05.&#xD;
&#xD;
      We expect that time and frequency parameters of HRV will increase in study group. 5% of the&#xD;
      limit value of p &lt;0.05.&#xD;
&#xD;
      We expect that parameters of HRT will improve in study group. 5% of the limit value of p&#xD;
      &lt;0.05.&#xD;
&#xD;
      We expect improvement in RHI in study group. 5% of the limit value of p &lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 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>5 Years</target_duration>
  <primary_outcome>
    <measure>Arterial stiffness - Pulse wave velocity (PWV)</measure>
    <time_frame>24 month</time_frame>
    <description>Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial stiffness - Ambulatory arterial stiffness index (AASI)</measure>
    <time_frame>24 month</time_frame>
    <description>AASI index will be calculated by non-commercial software using data from ambulatory blood pressure monitoring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial stiffness - Augmentation index (AI)</measure>
    <time_frame>24 month</time_frame>
    <description>AI will be calculated by EndoPAT2000 system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability (HRV)</measure>
    <time_frame>24 month</time_frame>
    <description>HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate turbulence (HRT)</measure>
    <time_frame>24 month</time_frame>
    <description>HRT parameters will be calculated by Cardioscan 10 software.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Endothelial function - Reactive hyperaemia index(RHI)</measure>
    <time_frame>24 month</time_frame>
    <description>RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.</description>
  </other_outcome>
  <other_outcome>
    <measure>Endothelial function - VEGF-A, ADMA</measure>
    <time_frame>24 month</time_frame>
    <description>Group of 40 patient will be involved in sub-study with assessment of 2 markers of endothelial function:&#xD;
Vascular Endothelial Growth Factor A (VEGF-A) will be obtained by ELISA method to assess collateral circulation development during ischemia.&#xD;
Asymmetric dimethylarginine (ADMA) will be obtained by ELISA method to assess the ability of the synthesis of nitric oxide.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Arterial Stiffness</condition>
  <condition>Endothelial Function</condition>
  <condition>Autonomic Nervous System</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>CR with AH</arm_group_label>
    <description>Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N-CR with AH</arm_group_label>
    <description>Patients after ACS with arterial hypertension don't treat with comprehensive cardiac rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CR without AH</arm_group_label>
    <description>Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>comprehensive cardiac rehabilitation</intervention_name>
    <description>Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.</description>
    <arm_group_label>CR with AH</arm_group_label>
    <arm_group_label>CR without AH</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      VEGF-A, ADMA, NT-proBNP, creatinine, uric acid, LDL, HDL, total cholesterol, trigliceride,&#xD;
      ALT,GGTP, CRP, fibrinogen,&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient after troponin-positive acute coronary syndrome (ACS) with or without arterial&#xD;
        hypertension.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  after a recent troponin-positive acute coronary syndrome (within 7-30 days) treated by&#xD;
             means of primary coronary angioplasty,&#xD;
&#xD;
          -  age 20-85 year old,&#xD;
&#xD;
          -  accepted and sign informed consent,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable coronary artery disease,&#xD;
&#xD;
          -  indications for a coronary artery bypass graft (CABG),&#xD;
&#xD;
          -  peripheral artery disease,&#xD;
&#xD;
          -  uncontrolled arterial hypertension,&#xD;
&#xD;
          -  ventricular and supraventricular arrhythmias in excess of 10% of all the evolutions&#xD;
             throughout the day,&#xD;
&#xD;
          -  allergy to latex,&#xD;
&#xD;
          -  deformities or condition after the amputation of fingers,&#xD;
&#xD;
          -  body mass index (BMI) above 35 kg/m2,&#xD;
&#xD;
          -  a significant hepatic or renal failure,&#xD;
&#xD;
          -  infectious disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malgorzata Kurpesa, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Departament of Cardiology Medical University of Lodz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departament of Cardiology</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lodz</investigator_affiliation>
    <investigator_full_name>Urszula Cieslik-Guerra</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Arterial stiffness,</keyword>
  <keyword>endothelial function,</keyword>
  <keyword>autonomic nervous system,</keyword>
  <keyword>acute coronary syndrome,</keyword>
  <keyword>arterial hypertension,</keyword>
  <keyword>pulse wave velocity,</keyword>
  <keyword>augmentation index,</keyword>
  <keyword>arterial stiffness index,</keyword>
  <keyword>heart rate variability,</keyword>
  <keyword>heart rate turbulence,</keyword>
  <keyword>vascular endothelial growth factor,</keyword>
  <keyword>asymmetric dimethylarginine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Acute Coronary Syndrome</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/NCT02195388
org study id: FOREVER-1
nct id: NCT02195388
lead sponsor: 
has dmc: Yes
Myocardial infarction is related with endothelial function, arterial stiffness and autonomic
      nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is
      also related with endothelial function, arterial stiffness and autonomic nervous system
      dysfunction.

      Primary aim of study is to investigate how complex cardiac rehabilitation influence
      endothelial function, arterial stiffness and autonomic nervous system activity according to
      presence or absence arterial hypertension.

      Secondary aim is to obtain correlation between methods for the assessment of particular
      disorders and intercorrelation between different disorders for example endothelial function
      and autonomic nervous system activity.
We expect that in study groups PWV will improve better that in control group. 5% of the limit
      value of p <0.05.

      We expect that in study groups AASI will improve better that in control group. 5% of the
      limit value of p <0.05.

      We expect that in study groups AI will improve better that in control group. 5% of the limit
      value of p <0.05.

      We expect that time and frequency parameters of HRV will increase in study group. 5% of the
      limit value of p <0.05.

      We expect that parameters of HRT will improve in study group. 5% of the limit value of p
      <0.05.

      We expect improvement in RHI in study group. 5% of the limit value of p <0.05.
observational model: Cohort
time perspective: Prospective
measure: Arterial stiffness - Pulse wave velocity (PWV)
time frame: 24 month
description: Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device.
measure: Arterial stiffness - Ambulatory arterial stiffness index (AASI)
time frame: 24 month
description: AASI index will be calculated by non-commercial software using data from ambulatory blood pressure monitoring.
measure: Arterial stiffness - Augmentation index (AI)
time frame: 24 month
description: AI will be calculated by EndoPAT2000 system.
measure: Heart rate variability (HRV)
time frame: 24 month
description: HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.
measure: Heart rate turbulence (HRT)
time frame: 24 month
description: HRT parameters will be calculated by Cardioscan 10 software.
measure: Endothelial function - Reactive hyperaemia index(RHI)
time frame: 24 month
description: RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.
measure: Endothelial function - VEGF-A, ADMA
time frame: 24 month
description: Group of 40 patient will be involved in sub-study with assessment of 2 markers of endothelial function:
Vascular Endothelial Growth Factor A (VEGF-A) will be obtained by ELISA method to assess collateral circulation development during ischemia.
Asymmetric dimethylarginine (ADMA) will be obtained by ELISA method to assess the ability of the synthesis of nitric oxide.
arm group label: CR with AH
description: Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation
arm group label: N-CR with AH
description: Patients after ACS with arterial hypertension don't treat with comprehensive cardiac rehabilitation.
arm group label: CR without AH
description: Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation
intervention type: Other
intervention name: comprehensive cardiac rehabilitation
description: Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.
arm group label: CR with AH
arm group label: CR without AH
VEGF-A, ADMA, NT-proBNP, creatinine, uric acid, LDL, HDL, total cholesterol, trigliceride,
      ALT,GGTP, CRP, fibrinogen,
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Malgorzata Kurpesa, Professor
role: Study Chair
affiliation: Departament of Cardiology Medical University of Lodz
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lodz
investigator full name: Urszula Cieslik-Guerra
investigator title: M.D.
mesh term: Hypertension
mesh term: Acute Coronary Syndrome