Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04327258
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2020-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood (plasma and cells)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of NPPA/NPPB haplotype on natriuretic peptide plasma levels', 'timeFrame': 'Blood samples collected at start of anesthetic procedure', 'description': 'Estimation of genetic effects on natriuretic peptide (BNP, NT-proBNP) plasma levels'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['genetic association study'], 'conditions': ['Anesthesia', 'Surgical Procedure, Operative']}, 'descriptionModule': {'briefSummary': 'Crosssectional study to analyse the genetic influence on levels of cardiac biomarkers (BNP, NT-proBNP).', 'detailedDescription': 'Background\n\nNatriuretic peptides play an important role in risk stratification and management of patients undergoing non-cardiac surgery. However, due to genetic variability, the levels of these biomarkers may differ in individual patients with cardiac derangement. In the preoperative setting, genetic contribution to natriuretic peptide plasma level variability has not yet been determined.\n\nObjective\n\nThe aim of this study is to assess genetic contribution to NP plasma level variability in a Swiss cohort.\n\nMethods\n\nCross-sectional association study in a cohort of non-cardiac surgery patients.\n\nThis study is a Subproject of a prospective cohort study registered under the ID 041/09.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Written informed consent\n* Scheduled surgery\n\nExclusion Criteria\n\n* No informed consent\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04327258', 'briefTitle': 'The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels', 'orgStudyIdInfo': {'id': '041/09e'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients', 'description': 'Patients undergoing elective surgery with anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Frank Stüber, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern'}, {'name': 'Ulrike M Stamer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}