<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/NCT03250455</url>
  </required_header>
  <id_info>
    <org_study_id>CIFuwaiHospital-2</org_study_id>
    <nct_id>NCT03250455</nct_id>
  </id_info>
  <brief_title>Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis</brief_title>
  <acronym>VALIDITY</acronym>
  <official_title>Prognostic Value of CT dynamIc Myocardial Perfusion in Patients With Obstructive Coronary Artery Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</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>
      VALIDITY is a prospective, open-label, multicenter, randomized controlled trial&#xD;
      （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive&#xD;
      anatomic CTA combined with functional CTP for the next clinical decision making and the added&#xD;
      prognostic value of CTP beyond CTA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>3 Years</target_duration>
  <primary_outcome>
    <measure>MACE</measure>
    <time_frame>90 days, 6 months, 12 months, 24 months and 36 months</time_frame>
    <description>death, myocardial infarction and unstable angina requiring hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>invasive coronary angiography and revascularization</measure>
    <time_frame>90 days, 6 months, 12 months, 24 months and 36 months</time_frame>
    <description>invasive coronary angiography and PCI or CABG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>he incidence of a composite of major complications from cardiovascular procedures and testing</measure>
    <time_frame>90 days, 6 months, 12 months, 24 months and 36 months</time_frame>
    <description>stroke, bleeding, anaphylaxis, renal failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>90 days, 6 months, 12 months, 24 months and 36</time_frame>
    <description>Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total medical cost</measure>
    <time_frame>90 days and 3 years</time_frame>
    <description>Assess and compare total medical cost for the two diagnostic testing arms by intention to treat</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1748</enrollment>
  <condition>CT Perfusion</condition>
  <arm_group>
    <arm_group_label>CTA+CTP</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CTA only</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CTA CTP</intervention_name>
    <description>CT Angiography myocardial CT Perfusion</description>
    <arm_group_label>CTA+CTP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CTA</intervention_name>
    <description>CT Angiography</description>
    <arm_group_label>CTA only</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with stable chest pain and diagnosed of obstructive coronary stenosis (50-90%) by&#xD;
        CTA were enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥18 years.&#xD;
&#xD;
          2. stable chest pain with obstructive coronary stenosis (50-90%) assessed by CTA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or&#xD;
             urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band&#xD;
             (CK-MB).&#xD;
&#xD;
             (2) Hemodynamically or clinically unstable condition systolic blood pressure (BP) &lt; 90&#xD;
             mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be&#xD;
             ischemic despite adequate therapy.&#xD;
&#xD;
             (3) Known CAD with prior Myocardial infarction (MI), percutaneous coronary&#xD;
             intervention (PCI), coronary artery bypass graft (CABG).&#xD;
&#xD;
             (4) Known significant congenital, valvular (&gt; moderate) or cardiomyopathic process&#xD;
             (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤&#xD;
             40%)) which could explain cardiac symptoms.&#xD;
&#xD;
             (5) Contraindication to undergoing CTA, including but not limited to: a. Allergy to&#xD;
             iodinated contrast agent, b. Unable to receive beta blockers, c. creatinine ≥1.7 mg/dl&#xD;
             or GFR≤30 ml/min , d. Pregnancy.&#xD;
&#xD;
             (6) Contraindication to ATP, including but not limited to: a. II or III&#xD;
             atrioventricular block, b. bronchial asthma, c. hypotension (SBP&lt;90mmHg), d. bronchial&#xD;
             stenosis or bronchospasm, e. acute myocardial infarction, f. left main stenosis, g.&#xD;
             unstable angina, h. allergy to aminophylline.&#xD;
&#xD;
             (7) Life expectancy &lt; 2 years. (8) Unable to provide written informed consent or&#xD;
             participate in long-term follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Bin Lu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Gao, MD</last_name>
    <phone>86-10-88328651</phone>
    <email>gaoyang226@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bin Lu, MD</last_name>
      <phone>86-10-88322662</phone>
      <email>blu@vip.sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Yang Gao, MD</last_name>
      <phone>86-10-88322651</phone>
      <email>gaoyang226@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Bin Lu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang Gao, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xiehe Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yingning Wang, MD</last_name>
      <phone>86-10-13661003076</phone>
      <email>yiningpumc@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Lu Lin, MD</last_name>
      <phone>86-10-13520298919</phone>
      <email>linlu03@sina.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hui Liu, MD</last_name>
      <phone>8613580352002</phone>
      <email>13580352002@139.com</email>
    </contact>
    <contact_backup>
      <last_name>Hui Gu, MD</last_name>
      <phone>86-0531-68776770</phone>
      <email>18201287661@126.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Shanghai Sixth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiayin Zhang, MD</last_name>
      <phone>86-20-18930173280</phone>
      <email>andrewssmu@msn.com</email>
    </contact>
    <contact_backup>
      <last_name>Jian Ma, MD</last_name>
      <phone>86-20-18930174762</phone>
      <email>drmajian@126.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>General hospital of tianjin medical university</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhang Zhang, MD</last_name>
      <phone>15900388839</phone>
      <email>filea1249@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Dong Li, MD</last_name>
      <phone>15222709990</phone>
      <email>dr_lidong@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Bin Lu</investigator_full_name>
    <investigator_title>chief of Radilogy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03250455
org study id: CIFuwaiHospital-2
nct id: NCT03250455
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
VALIDITY is a prospective, open-label, multicenter, randomized controlled trial
      （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive
      anatomic CTA combined with functional CTP for the next clinical decision making and the added
      prognostic value of CTP beyond CTA.
observational model: Cohort
time perspective: Prospective
measure: MACE
time frame: 90 days, 6 months, 12 months, 24 months and 36 months
description: death, myocardial infarction and unstable angina requiring hospitalization
measure: invasive coronary angiography and revascularization
time frame: 90 days, 6 months, 12 months, 24 months and 36 months
description: invasive coronary angiography and PCI or CABG
measure: he incidence of a composite of major complications from cardiovascular procedures and testing
time frame: 90 days, 6 months, 12 months, 24 months and 36 months
description: stroke, bleeding, anaphylaxis, renal failure
measure: Quality of Life
time frame: 90 days, 6 months, 12 months, 24 months and 36
description: Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
measure: total medical cost
time frame: 90 days and 3 years
description: Assess and compare total medical cost for the two diagnostic testing arms by intention to treat
arm group label: CTA+CTP
arm group label: CTA only
intervention type: Diagnostic Test
intervention name: CTA CTP
description: CT Angiography myocardial CT Perfusion
arm group label: CTA+CTP
intervention type: Diagnostic Test
intervention name: CTA
description: CT Angiography
arm group label: CTA only
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Bin Lu, MD
role: Principal Investigator
affiliation: Fuwai Hospital
last name: Yang Gao, MD
phone: 86-10-88328651
email: gaoyang226@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Bin Lu
investigator title: chief of Radilogy
mesh term: Coronary Stenosis
sharing ipd: Undecided