Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-18 @ 10:28 AM
Study NCT ID:
NCT03791359
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2018-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Project of Out Of Hospital Cardiac Arrests in Warangal Area,Telangana,India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016887', 'term': 'Cardiopulmonary Resuscitation'}], 'ancestors': [{'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2018-12-31', 'studyFirstSubmitQcDate': '2018-12-31', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival with good neurological state of OOHCA victims', 'timeFrame': 'From cardiac arrest upto 3 months and beyond.', 'description': 'Percentage of those who survived an instance of OOHCA with good neurological outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Out- of- Hospital Cardiac Arrest'], 'conditions': ['Out-Of-Hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'This Pilot project is an observational study of a cohort of participants (victims) of Out of Hospital Cardiac Arrests in Warangal area ,Telangana ,India .\n\nStarted on January 1,2018 to December 2018.', 'detailedDescription': "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.\n\nWith 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.\n\nObjectives: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.\n\n2.To compile reports which might be useful to improve the links in the survival of OOHCA victims.\n\nMethods 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.\n\nSources 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.\n\nAcknowledgements: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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants(victims) of Out Of Hospital Cardiac Arrest above 18 years.\n\nExclusion Criteria:\n\n\\*Participants(victims) of OOHCA whose data is not available or whose attendants are unwilling to share the data are excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03791359', 'acronym': 'WACAR', 'briefTitle': 'A Pilot Project of Out Of Hospital Cardiac Arrests in Warangal Area,Telangana,India', 'organization': {'class': 'OTHER', 'fullName': 'Srinivasa Heart Centre'}, 'officialTitle': 'Warangal Area Out of Hospital Cardiac Arrest Registry-A Pilot Project In India (WACAR)', 'orgStudyIdInfo': {'id': 'KIEC/KMC/NCT/NIS/2018/CAR01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CardioPulmonary Resuscitation', 'type': 'OTHER', 'description': 'Whether the victim received CPR as per standard protocol.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '506001', 'city': 'Warangal', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'SRINIVAS RAMAKA', 'role': 'CONTACT', 'email': 'srinivasaheartcentre@outlook.com', 'phone': '00919390105045'}], 'facility': 'Srinivasa Heart Centre', 'geoPoint': {'lat': 18.0, 'lon': 79.58333}}], 'centralContacts': [{'name': 'Srinivas Ramaka, MD', 'role': 'CONTACT', 'email': 'srinivasaheartcentre@outlook.com', 'phone': '00919390105045'}], 'overallOfficials': [{'name': 'Srinivas Ramaka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Srinivasa Heart Centre'}, {'name': 'Vemuri S Murthy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Illinois, Chicago,Illinois'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will inform later as this is a Pilot Study in India.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SRINIVAS RAMAKA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SRINIVAS RAMAKA', 'investigatorAffiliation': 'Srinivasa Heart Centre'}}}}