<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/NCT03791359</url>
  </required_header>
  <id_info>
    <org_study_id>KIEC/KMC/NCT/NIS/2018/CAR01</org_study_id>
    <nct_id>NCT03791359</nct_id>
  </id_info>
  <brief_title>A Pilot Project of Out Of Hospital Cardiac Arrests in Warangal Area,Telangana,India</brief_title>
  <acronym>WACAR</acronym>
  <official_title>Warangal Area Out of Hospital Cardiac Arrest Registry-A Pilot Project In India (WACAR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SRINIVAS RAMAKA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Srinivasa Heart Centre</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>
      This Pilot project is an observational study of a cohort of participants (victims) of Out of&#xD;
      Hospital Cardiac Arrests in Warangal area ,Telangana ,India .&#xD;
&#xD;
      Started on January 1,2018 to December 2018.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction and Background:Cardiac arrest is an important public health problem&#xD;
      worldwide.Registries on Out Of Hospital Cardiac arrest(OOHCA) not only contribute to research&#xD;
      and surveillance but also provide inputs to improve the links in the Chain of&#xD;
      Survival.Whereas various registries on OOHCA exist and are ongoing globally ,registries and&#xD;
      studies on OOHCA are limited in India.The awareness on Cardiovascular Health, Cardiac Arrest&#xD;
      and CPR is less in India when compared to some developed countries.A study done earlier noted&#xD;
      the lack of awareness on Cardiovascular Health,cardiac arrest and CPR in a cohort of Indian&#xD;
      population.This study pointed the need to increase awareness on CV health,cardiac arrest and&#xD;
      CPR among Indian population(abstract presented by Dr Srinivas Ramaka at the World Congress of&#xD;
      Cardiology,2016).There is a dire need to improve the survival of victims of OOHCA in India.&#xD;
&#xD;
      With this background and understanding,the need for a Registry on OOHCA ,the Warangal Area&#xD;
      Out Of Hospital Cardiac Arrest Registry has been initiated in January 2018 as a Pilot study&#xD;
      in India.&#xD;
&#xD;
      Objectives:1.To collect available OOHCA data for one year from a selected geographical area&#xD;
      in India following an International standard format(Utstein Template) tailored to India.&#xD;
&#xD;
      2.To compile reports which might be useful to improve the links in the survival of OOHCA&#xD;
      victims.&#xD;
&#xD;
      Methods and study design:This is an Observational study of a cohort of Out of Hospital&#xD;
      cardiac arrest victims. Geographical area:Warangal and surroundings ,Telangana state. Time&#xD;
      frame--January 1 ,2018 to December 31,2018.As it is both a surveillance and research&#xD;
      study,the project is proposed to be continued mostly for another year 2019 depending on&#xD;
      logistic support and feasibility.&#xD;
&#xD;
      Sources of data:Mahatma Gandhi Memorial Hospital,participating local hospitals and practising&#xD;
      physicians,reports from local media,local governmental agencies,births and deaths department&#xD;
      of local Municipal Corporation and district medical and health officials.MGM Hospital is a&#xD;
      secondary care govt hospital catering to the medical needs of Warangal and surrounding&#xD;
      districts.Data of victims brought in cardiac arrest or declared dead on arrival is collected&#xD;
      from the Casualty or Emergency dept .Missing data or additional information is collected&#xD;
      telephonically from the victim's relatives and attendants.The local legal and ethical&#xD;
      guidelines are followed in collecting the data.Data is collected on a standard report form&#xD;
      /Online fillable pdf which includes the variables as mentioned in the data collection&#xD;
      form,participants/cohorts of victims of OOHCA,definition of OOHCA,inclusion criteria,sources&#xD;
      of information collected in person or telephonically,consent,methods of selection of&#xD;
      participants and methods of followup.Data is entered in standard excel format and will be&#xD;
      analyzed according to appropriate/standard statistical methods.Permission from the hospital&#xD;
      administration and all concerned is taken prior.At present there is no funding for the&#xD;
      project.Dr Srinivas Ramaka is the Principal Investigator. Dr Vemuri S Murthy from USA is the&#xD;
      coinvestigator in this project.&#xD;
&#xD;
      Acknowledgements:Superintendent,MGM Hospital,Warangal,DMHO ,Warangal,Registrar ,Births and&#xD;
      Deaths,Warangal,doctors and Staff,Casualty,MGM Hospital,.Dept of Medicine,MGM Hospital,local&#xD;
      medical and pharmacy students, local media, and relatives and attendants of victims of OOHCA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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 Months</target_duration>
  <primary_outcome>
    <measure>Survival with good neurological state of OOHCA victims</measure>
    <time_frame>From cardiac arrest upto 3 months and beyond.</time_frame>
    <description>Percentage of those who survived an instance of OOHCA with good neurological outcome</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Out-Of-Hospital Cardiac Arrest</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CardioPulmonary Resuscitation</intervention_name>
    <description>Whether the victim received CPR as per standard protocol.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of victims of Out of Hospital Cardiac arrests which occur in&#xD;
        Warangal Area,Telangana State ,India from January 1 2018 to December 2018.Survival outcomes&#xD;
        and other variables as mentioned in the study protocol are studied.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants(victims) of Out Of Hospital Cardiac Arrest above 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        *Participants(victims) of OOHCA whose data is not available or whose attendants are&#xD;
        unwilling to share the data are excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Srinivas Ramaka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Srinivasa Heart Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vemuri S Murthy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Illinois, Chicago,Illinois</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Srinivas Ramaka, MD</last_name>
    <phone>00919390105045</phone>
    <email>srinivasaheartcentre@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Srinivasa Heart Centre</name>
      <address>
        <city>Warangal</city>
        <state>Telangana</state>
        <zip>506001</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SRINIVAS RAMAKA</last_name>
      <phone>00919390105045</phone>
      <email>srinivasaheartcentre@outlook.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Srinivasa Heart Centre</investigator_affiliation>
    <investigator_full_name>SRINIVAS RAMAKA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Out- of- Hospital Cardiac Arrest</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Will inform later as this is a Pilot Study in India.</ipd_description>
  </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/NCT03791359
org study id: KIEC/KMC/NCT/NIS/2018/CAR01
nct id: NCT03791359
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This Pilot project is an observational study of a cohort of participants (victims) of Out of
      Hospital Cardiac Arrests in Warangal area ,Telangana ,India .

      Started on January 1,2018 to December 2018.
Introduction and Background:Cardiac arrest is an important public health problem
      worldwide.Registries on Out Of Hospital Cardiac arrest(OOHCA) not only contribute to research
      and surveillance but also provide inputs to improve the links in the Chain of
      Survival.Whereas various registries on OOHCA exist and are ongoing globally ,registries and
      studies on OOHCA are limited in India.The awareness on Cardiovascular Health, Cardiac Arrest
      and CPR is less in India when compared to some developed countries.A study done earlier noted
      the lack of awareness on Cardiovascular Health,cardiac arrest and CPR in a cohort of Indian
      population.This study pointed the need to increase awareness on CV health,cardiac arrest and
      CPR among Indian population(abstract presented by Dr Srinivas Ramaka at the World Congress of
      Cardiology,2016).There is a dire need to improve the survival of victims of OOHCA in India.

      With this background and understanding,the need for a Registry on OOHCA ,the Warangal Area
      Out Of Hospital Cardiac Arrest Registry has been initiated in January 2018 as a Pilot study
      in India.

      Objectives:1.To collect available OOHCA data for one year from a selected geographical area
      in India following an International standard format(Utstein Template) tailored to India.

      2.To compile reports which might be useful to improve the links in the survival of OOHCA
      victims.

      Methods and study design:This is an Observational study of a cohort of Out of Hospital
      cardiac arrest victims. Geographical area:Warangal and surroundings ,Telangana state. Time
      frame--January 1 ,2018 to December 31,2018.As it is both a surveillance and research
      study,the project is proposed to be continued mostly for another year 2019 depending on
      logistic support and feasibility.

      Sources of data:Mahatma Gandhi Memorial Hospital,participating local hospitals and practising
      physicians,reports from local media,local governmental agencies,births and deaths department
      of local Municipal Corporation and district medical and health officials.MGM Hospital is a
      secondary care govt hospital catering to the medical needs of Warangal and surrounding
      districts.Data of victims brought in cardiac arrest or declared dead on arrival is collected
      from the Casualty or Emergency dept .Missing data or additional information is collected
      telephonically from the victim's relatives and attendants.The local legal and ethical
      guidelines are followed in collecting the data.Data is collected on a standard report form
      /Online fillable pdf which includes the variables as mentioned in the data collection
      form,participants/cohorts of victims of OOHCA,definition of OOHCA,inclusion criteria,sources
      of information collected in person or telephonically,consent,methods of selection of
      participants and methods of followup.Data is entered in standard excel format and will be
      analyzed according to appropriate/standard statistical methods.Permission from the hospital
      administration and all concerned is taken prior.At present there is no funding for the
      project.Dr Srinivas Ramaka is the Principal Investigator. Dr Vemuri S Murthy from USA is the
      coinvestigator in this project.

      Acknowledgements:Superintendent,MGM Hospital,Warangal,DMHO ,Warangal,Registrar ,Births and
      Deaths,Warangal,doctors and Staff,Casualty,MGM Hospital,.Dept of Medicine,MGM Hospital,local
      medical and pharmacy students, local media, and relatives and attendants of victims of OOHCA.
observational model: Cohort
time perspective: Prospective
measure: Survival with good neurological state of OOHCA victims
time frame: From cardiac arrest upto 3 months and beyond.
description: Percentage of those who survived an instance of OOHCA with good neurological outcome
intervention type: Other
intervention name: CardioPulmonary Resuscitation
description: Whether the victim received CPR as per standard protocol.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Srinivas Ramaka, MD
role: Principal Investigator
affiliation: Srinivasa Heart Centre
last name: Vemuri S Murthy, MD
role: Study Chair
affiliation: University of Illinois, Chicago,Illinois
last name: Srinivas Ramaka, MD
phone: 00919390105045
email: srinivasaheartcentre@outlook.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: Srinivasa Heart Centre
investigator full name: SRINIVAS RAMAKA
investigator title: Principal Investigator
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: Undecided
ipd description: Will inform later as this is a Pilot Study in India.