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Out-Of-Hospital Cardiac ArrestWACARNCT03791359

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

An observational study of Out-Of-Hospital Cardiac Arrest, run by SRINIVAS RAMAKA at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Out-Of-Hospital Cardiac Arrest
What is being tested?
CardioPulmonary Resuscitation
How many people
500 participants
Where
1 siteIndia
Study dates
1 Jan 2018to 31 Mar 2019
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site, 1 recruiting
  • Srinivasa Heart Centre

    Warangal, Telangana, 506001

    SRINIVAS RAMAKA, 00919390105045, srinivasaheartcentre@outlook.com

    Recruiting

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
CardioPulmonary Resuscitation
Keywords
Out- of- Hospital Cardiac Arrest
Medical subject headings
Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioPulmonary ResuscitationOther

    Whether the victim received CPR as per standard protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival with good neurological state of OOHCA victims

    Percentage of those who survived an instance of OOHCA with good neurological outcome

    Measured: From cardiac arrest upto 3 months and beyond.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Mar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791359
Sponsor's protocol ID
KIEC/KMC/NCT/NIS/2018/CAR01
Acronym
WACAR
Status last verified
Dec 2018
First submitted
31 Dec 2018
Last updated
3 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will inform later as this is a Pilot Study in India.

Questions about this trial

What is this clinical trial studying?

An observational study of Out-Of-Hospital Cardiac Arrest, run by SRINIVAS RAMAKA at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Srinivas Ramaka, MD (00919390105045, srinivasaheartcentre@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival with good neurological state of OOHCA victims (time frame: From cardiac arrest upto 3 months and beyond.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.

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