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.
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
- Recruiting
Srinivasa Heart Centre
Warangal, Telangana, 506001
SRINIVAS RAMAKA, 00919390105045, srinivasaheartcentre@outlook.com
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.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- 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.
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.
- First posted2 Jan 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- SRINIVAS RAMAKA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SRINIVAS RAMAKA, Srinivasa Heart Centre
- Investigators
- Srinivas Ramaka, MD, Principal investigator, Srinivasa Heart CentreVemuri S Murthy, MD, Study chair, University of Illinois, Chicago,Illinois
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warangal Area Out of Hospital Cardiac Arrest Registry-A Pilot Project In India (WACAR)
- ClinicalTrials.gov ID
- NCT03791359
- Acronym / sponsor ID
- WACAR / KIEC/KMC/NCT/NIS/2018/CAR01
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Out- of- Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- SRINIVAS RAMAKAUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All participants(victims) of Out Of Hospital Cardiac Arrest above 18 years.
Key exclusion criteria (1 listed)
- Participants(victims) of OOHCA whose data is not available or whose attendants are unwilling to share the data are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioPulmonary ResuscitationWhether the victim received CPR as per standard protocol. | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Individual participant dataSharing planned: Undecided. Will inform later as this is a Pilot Study in India.
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas Ramaka, MD principal investigator
Srinivasa Heart Centre
Vemuri S Murthy, MD study chair
University of Illinois, Chicago,Illinois
1 site in 1 country: see every site and its status.
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.