Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04838418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2021-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'microRNA, copeptine and NSE sampling'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value of ONSD for short-term neurological outcome prediction', 'timeFrame': '30 days', 'description': 'Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and neurological outcome of patients (quantified by the CPC scale) after out of hospital cardiac arrest with subsequent ROSC'}, {'measure': 'Value of ONSD for short-term mortality prediction', 'timeFrame': '30 days', 'description': 'Assessment of the correlation between optic nerve sheath diameter measured by transorbital ultrasonography and mortality during a 30-day follow-up.'}], 'secondaryOutcomes': [{'measure': 'Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction', 'timeFrame': '96 hours', 'description': 'Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and negative prognostic markers obtained by somatosensory evoked potentials examination and EEG in patients remaining in a coma even after the end of therapeutic hypothermia and sedation.'}, {'measure': 'Comparison of ONSD measurements by ultrasonography and computed tomography', 'timeFrame': '48 hours', 'description': 'Assessment of accuracy of the optic nerve sheath diameter measured by ultrasonography compared to CT measurement performed 48 ± 12 hours after achievment of ROSC.'}, {'measure': 'Correlation between ONSD and fundoscopic signs of papillary edema', 'timeFrame': '48 hours', 'description': 'Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and grade of optic nerve papillary edema quantified by the Frisen scale on fundoscopic examination performed 48 ± 12 hours after achievment of ROSC.'}, {'measure': 'Correlation between ONSD and thickness of retinal nerve fibers measured by OCT', 'timeFrame': '5 months', 'description': 'Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and thickness of retinal nerve fibers measured by optical coherence tomography at time intervals of 1, 3 and 5 months after achievment of ROSC.'}, {'measure': 'Effect of blood carbon dioxide on ONSD', 'timeFrame': '72 hours', 'description': 'Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and paCO2 and ETCO2 values at the time of measurement.'}, {'measure': 'Value of ONSD for long-term neurological outcome and mortality', 'timeFrame': '6 months', 'description': 'Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and mortality and neurological outcome of patients (quantified by the CPC scale) at 6 months after ROSC.'}, {'measure': 'Correlation between blood NSE, copeptin and selected RNAs', 'timeFrame': '6 months', 'description': 'Assessment of the correlation between blood NSE, copeptin and selected micro-RNAs measured at defined time intervals from ROSC, to neurological outcome prediction in patients after out of hospital cardiac arrest with subsequent ROSC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'In sudden cardiac arrest patients with return of spontaneous circulation, brain damage is one of the main determinants of short-term mortality and poor prognosis (CPC 3-5). It is important to properly select group of patients in whom treatment is futile. According to current guidelines, multimodal approach is recommended. Optic nerve sheath diameter measured by ultrasound is non-invasive, fast, low-cost and readily available bed-side method, but evidence for its use as neuroprognostication modality is limited to only few small studies. The aim of this study is to evaluate validity of ONSD as neuroprognostication method at larger cohort of patients, compare it with other established methods and compare ultrasound and CT measurement of ONSD.', 'detailedDescription': 'Additional relevant MeSH terms:\n\ncardiac arrest, cardiovascular diseases, optic nerve sheath diameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients after cardiac arrest with subsequent ROSC, 18 years of age and older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of 18 years or older\n* out of hospital cardiac arrest of non-traumatic cause with CPR and subsequent ROSC\n* Glasgow coma scale (GCS) ≤ 7 or sedation 30 minutes after ROSC achievment\n\nExclusion Criteria:\n\n* unavailable first measurment of the optic nerve sheath diameter (ONSD) measured by transorbital ultrasonography 24±6 hours after ROSC achievement\n* refractory cardiac arrest\n* craniocerebral injury\n* intracranial tumor\n* active intracranial bleeding\n* haemorrhagic stroke and/or subarachnoid haemorrhage in the last 3 months\n* facial trauma affecting the eye area\n* active neuroendocrine tumor, small cell lung cancer, non-small cell lung\n* CPC 3-5 before cardiac arrest\n* sclerosis multiplex and/or optic neuritis of other etiology'}, 'identificationModule': {'nctId': 'NCT04838418', 'acronym': 'TOMCAT', 'briefTitle': 'Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Pilsen'}, 'officialTitle': 'Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest (TOMCAT)', 'orgStudyIdInfo': {'id': 'TOMCAT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Optic nerve sheath diameter measured by transorbital ultrasound', 'type': 'PROCEDURE', 'description': 'Optic nerve sheath diameter measured 3 mm behind eyeball. For every eyeball 2 measurements in axial and 2 measurements in sagital projections are performed. Summary value for every eyeball is arithmetic mean from these 4 measurements.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pilsen', 'country': 'Czechia', 'facility': 'University Hospital Plzen', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}], 'overallOfficials': [{'name': 'Štefan Volovár, MUDr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital Plzen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Pilsen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Na Homolce Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}