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

Out-Of-Hospital Cardiac Arrest Clinical Trial

— WACAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791359
• Other study ID #: KIEC/KMC/NCT/NIS/2018/CAR01
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2018
• Source: Srinivasa Heart Centre
• Contact: Srinivas Ramaka, MD
• Phone: 00919390105045
• Email: srinivasaheartcentre[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• CardioPulmonary Resuscitation
Whether the victim received CPR as per standard protocol.

Locations

Country	Name	City	State
India	Srinivasa Heart Centre	Warangal	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SRINIVAS RAMAKA

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival with good neurological state of OOHCA victims	Percentage of those who survived an instance of OOHCA with good neurological outcome	From cardiac arrest upto 3 months and beyond.