A Pilot Project of Out Of Hospital Cardiac Arrests in Warangal Area,Telangana,India (WACAR)

December 31, 2018 updated by: SRINIVAS RAMAKA

Warangal Area Out of Hospital Cardiac Arrest Registry-A Pilot Project In India (WACAR)

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.

Study Overview

Status

Unknown

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of victims of Out of Hospital Cardiac arrests which occur in Warangal Area,Telangana State ,India from January 1 2018 to December 2018.Survival outcomes and other variables as mentioned in the study protocol are studied.

Description

Inclusion Criteria:

  • All participants(victims) of Out Of Hospital Cardiac Arrest above 18 years.

Exclusion Criteria:

*Participants(victims) of OOHCA whose data is not available or whose attendants are unwilling to share the data are excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival with good neurological state of OOHCA victims
Time Frame: From cardiac arrest upto 3 months and beyond.
Percentage of those who survived an instance of OOHCA with good neurological outcome
From cardiac arrest upto 3 months and beyond.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Srinivas Ramaka, MD, Srinivasa Heart Centre
  • Study Chair: Vemuri S Murthy, MD, University of Illinois, Chicago,Illinois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Anticipated)

March 31, 2019

Study Registration Dates

First Submitted

December 31, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 31, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • KIEC/KMC/NCT/NIS/2018/CAR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will inform later as this is a Pilot Study in India.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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