<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/NCT04407936</url>
  </required_header>
  <id_info>
    <org_study_id>GDREC2019555H</org_study_id>
    <nct_id>NCT04407936</nct_id>
  </id_info>
  <brief_title>Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention</brief_title>
  <official_title>Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As a single center, retrospective observation study in Guangdong Institute of Cardiovascular&#xD;
      Diseases, this study included the main study population of patients who underwent coronary&#xD;
      angiography and / or coronary intervention from January 2007 to Decemeber 2018. The&#xD;
      hospitalization information was collected in the form of direct derivation of the case, and&#xD;
      cardiac and renal adverse events were collected through outpatient recorder system. All-cause&#xD;
      death information was obtained from the Public Security and matched to the electronic&#xD;
      Clinical Management System of the Guangdong Provincial People's Hospital records.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, retrospective observation study collecting data on 88938 coronary&#xD;
      angiography and / or coronary intervention patients from January 2007 to Decemeber 2018. Data&#xD;
      regarding demographic information, admission diagnoses and history of present illness,&#xD;
      biomarkers and details on preventive hydration and medications will be collected. The primary&#xD;
      endpoint of this study is All-cause mortality, and secondary endpoints are Adverse&#xD;
      Cardiovascular and Kidney Events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2007</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>From hospital admission to 13 years follow-up</time_frame>
    <description>Admission Patients Died for all-cause mortality within 13 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)</measure>
    <time_frame>48 hours</time_frame>
    <description>defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cystatin C based CI-AKI (CI-AKI cyc)</measure>
    <time_frame>24-48 hours</time_frame>
    <description>Cystatin C based CI-AKI, defined as a ≥10% absolute increase in serum cystatin C during the first 24 hours after the procedure and and a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure.mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of eGFR, calculate based on CrCl and serum cystatin C</measure>
    <time_frame>48-72 hours</time_frame>
    <description>The eGFR creatinine-cystatin C was calculated by the 2012 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation: 135 *min(Scr/κ, 1)α * max(Scr/κ, 1)-0.601 * min(Scys/0.8, 1)-0.375 * max (Scys/0.8, 1)-0.711 * 0.995Age [* 0.969 if female] [* 1.08 if black], where Scr is serum creatinine, Scys is serum cystatin C, κ is 0.7 for females and 0.9 for males, α is -0.248 for females and -0.207 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast-induced Persistent kidney injury (CI-PKI)</measure>
    <time_frame>3 months</time_frame>
    <description>Serum creatinine was measured by endpoint colorimetry or enzymatic assays. CI-PKI was defined as residual impairment of renal function indicated by a ≥ 25% reduction in creatinine clearance at 3 months in comparison with baseline. comparison with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major adverse cardiovascular events</measure>
    <time_frame>3-12months</time_frame>
    <description>all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up major adverse cardiovascular and clinical events</measure>
    <time_frame>3-12months</time_frame>
    <description>We will follow up the patients by telephone and outpatient service to know the one year all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">88938</enrollment>
  <condition>Cardio-Renal Syndrome</condition>
  <condition>Coronary Angiography</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Kidney Diseases</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>coronary angiography</arm_group_label>
    <description>The investigators recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators reviewed all consecutive patients who were undergoing coronary&#xD;
        angiography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients referred to CAG or PCI;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liu Yong, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shiqun Chen, MS</last_name>
    <role>Study Director</role>
    <affiliation>Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
    <investigator_full_name>Jiyan Chen</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>contrast-induced acute kidney injury</keyword>
  <keyword>contrast medium</keyword>
  <keyword>creatinine clearance</keyword>
  <keyword>coronary angiography</keyword>
  <keyword>chronic kidney disease</keyword>
  <keyword>Adverse Cardiovascular and Kidney Events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Cardio-Renal Syndrome</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>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/NCT04407936
org study id: GDREC2019555H
nct id: NCT04407936
lead sponsor: 
has dmc: Yes
As a single center, retrospective observation study in Guangdong Institute of Cardiovascular
      Diseases, this study included the main study population of patients who underwent coronary
      angiography and / or coronary intervention from January 2007 to Decemeber 2018. The
      hospitalization information was collected in the form of direct derivation of the case, and
      cardiac and renal adverse events were collected through outpatient recorder system. All-cause
      death information was obtained from the Public Security and matched to the electronic
      Clinical Management System of the Guangdong Provincial People's Hospital records.
This is a single center, retrospective observation study collecting data on 88938 coronary
      angiography and / or coronary intervention patients from January 2007 to Decemeber 2018. Data
      regarding demographic information, admission diagnoses and history of present illness,
      biomarkers and details on preventive hydration and medications will be collected. The primary
      endpoint of this study is All-cause mortality, and secondary endpoints are Adverse
      Cardiovascular and Kidney Events.
observational model: Cohort
time perspective: Retrospective
measure: All-cause mortality
time frame: From hospital admission to 13 years follow-up
description: Admission Patients Died for all-cause mortality within 13 years.
measure: Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)
time frame: 48 hours
description: defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure
measure: Cystatin C based CI-AKI (CI-AKI cyc)
time frame: 24-48 hours
description: Cystatin C based CI-AKI, defined as a ≥10% absolute increase in serum cystatin C during the first 24 hours after the procedure and and a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure.mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure
measure: The change of eGFR, calculate based on CrCl and serum cystatin C
time frame: 48-72 hours
description: The eGFR creatinine-cystatin C was calculated by the 2012 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation: 135 *min(Scr/κ, 1)α * max(Scr/κ, 1)-0.601 * min(Scys/0.8, 1)-0.375 * max (Scys/0.8, 1)-0.711 * 0.995Age [* 0.969 if female] [* 1.08 if black], where Scr is serum creatinine, Scys is serum cystatin C, κ is 0.7 for females and 0.9 for males, α is -0.248 for females and -0.207 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
measure: Contrast-induced Persistent kidney injury (CI-PKI)
time frame: 3 months
description: Serum creatinine was measured by endpoint colorimetry or enzymatic assays. CI-PKI was defined as residual impairment of renal function indicated by a ≥ 25% reduction in creatinine clearance at 3 months in comparison with baseline. comparison with baseline
measure: Incidence of major adverse cardiovascular events
time frame: 3-12months
description: all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.
measure: Follow-up major adverse cardiovascular and clinical events
time frame: 3-12months
description: We will follow up the patients by telephone and outpatient service to know the one year all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.
arm group label: coronary angiography
description: The investigators recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Liu Yong, MD,PhD
role: Study Director
affiliation: Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
last name: Shiqun Chen, MS
role: Study Director
affiliation: Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial People's Hospital
investigator full name: Jiyan Chen
investigator title: Director
mesh term: Kidney Diseases
mesh term: Cardio-Renal Syndrome
mesh term: Coronary Artery Disease
mesh term: Metabolic Syndrome
mesh term: Syndrome