<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/NCT01671631</url>
  </required_header>
  <id_info>
    <org_study_id>FORECAST</org_study_id>
    <nct_id>NCT01671631</nct_id>
  </id_info>
  <brief_title>The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions</brief_title>
  <acronym>FORECAST</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Magna Graecia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Magna Graecia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration&#xD;
      is currently required for functional evaluation of stenosis severity using the fractional&#xD;
      flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the&#xD;
      instantaneous wave-free ratio (iFR), was recently introduced.&#xD;
&#xD;
      Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free&#xD;
      pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow&#xD;
      reserve (FFR) in ACS patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <study_type>Observational</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>
  <number_of_groups>1</number_of_groups>
  <condition>Functional Evaluation of Non Culprit Lesions in ACS Patients</condition>
  <arm_group>
    <arm_group_label>Acute Coronary Syndrome</arm_group_label>
    <description>Patients with Acute Coronary Syndrome and multivessel coronary artery disease undergoing functional evaluation of non-culprit lesions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurement of intracoronary pressure</intervention_name>
    <arm_group_label>Acute Coronary Syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Acute Coronary Syndrome and multivessel coronary artery disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 40 to 80 years&#xD;
&#xD;
          -  recent Acute Coronary Syndrome&#xD;
&#xD;
          -  indication for coronary angiography&#xD;
&#xD;
          -  presence of at least one non-culprit lesion requiring functional evaluation with&#xD;
             fractional flow reserve (FFR):&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Haemodynamically significant valvular disease&#xD;
&#xD;
          -  controindication for Adenosin administration&#xD;
&#xD;
          -  previous CABG on the index vessel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ciro Indolfi, Prof</last_name>
    <phone>+3909613647067</phone>
    <email>clinicaltrials-cardioumg@email.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cardiologia Interventistica UMG</name>
      <address>
        <city>Catanzaro</city>
        <state>Calabria</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ciro Indolfi, Prof.</last_name>
      <phone>+3909613647067</phone>
      <email>clinicaltrials-cardioumg@email.it</email>
    </contact>
    <investigator>
      <last_name>Ciro Indolfi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.dsmc.unicz.it</url>
    <description>Web site, Dipartimento di Scienze Mediche e Chirurgiche, Magna Graecia University</description>
  </link>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Magna Graecia</investigator_affiliation>
    <investigator_full_name>Ciro Indolfi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01671631
org study id: FORECAST
nct id: NCT01671631
lead sponsor: 
has dmc: No
The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration
      is currently required for functional evaluation of stenosis severity using the fractional
      flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the
      instantaneous wave-free ratio (iFR), was recently introduced.

      Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free
      pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow
      reserve (FFR) in ACS patients.
observational model: Cohort
time perspective: Prospective
arm group label: Acute Coronary Syndrome
description: Patients with Acute Coronary Syndrome and multivessel coronary artery disease undergoing functional evaluation of non-culprit lesions.
intervention type: Other
intervention name: Measurement of intracoronary pressure
arm group label: Acute Coronary Syndrome
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ciro Indolfi, Prof
phone: +3909613647067
email: clinicaltrials-cardioumg@email.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
url: http://www.dsmc.unicz.it
description: Web site, Dipartimento di Scienze Mediche e Chirurgiche, Magna Graecia University
responsible party type: Principal Investigator
investigator affiliation: University Magna Graecia
investigator full name: Ciro Indolfi
investigator title: Professor