Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-06 @ 12:39 AM
Study NCT ID:
NCT01794832
Status:
UNKNOWN
Last Update Posted:
2014-04-03
First Post:
2013-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Aortic Stenosis in Patients Referred for Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, myocardial biopsi'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2013-02-16', 'studyFirstSubmitQcDate': '2013-02-19', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Health related Quality and function one year after inclusion', 'timeFrame': 'one year', 'description': 'Patients in the study perform Short Form-36, EuroQual-5D at inclusion and one year after. We want to compare the result of their scoring to obtain the gain in HRQoL of the intervention'}, {'measure': 'Hospital visit and use of Health services last years', 'timeFrame': '30 days'}], 'primaryOutcomes': [{'measure': 'Death due cardiovascular events', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'MACE ( Major cardiovascular events )', 'timeFrame': '30 days', 'description': 'Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HRQoL', 'Aortic stenosis', 'Aortic valve surgery'], 'conditions': ['Aortic Stenosis', 'Valvular Heart Disease', 'Symptomatic Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '32962417', 'type': 'DERIVED', 'citation': 'Arain F, Abraityte A, Bogdanova M, Solberg OG, Michelsen AE, Lekva T, Aakhus S, Holm S, Halvorsen B, Finsen AV, Vinge LE, Nymo S, Espeland T, Ranheim T, Aukrust P, Vaage IJ, Auensen A, Gullestad L, Ueland T. YKL-40 (Chitinase-3-Like Protein 1) Serum Levels in Aortic Stenosis. Circ Heart Fail. 2020 Oct;13(10):e006643. doi: 10.1161/CIRCHEARTFAILURE.119.006643. Epub 2020 Sep 23.'}, {'pmid': '30613413', 'type': 'DERIVED', 'citation': 'Kvaslerud AB, Hussain AI, Auensen A, Ueland T, Michelsen AE, Pettersen KI, Aukrust P, Morkrid L, Gullestad L, Broch K. Prevalence and prognostic implication of iron deficiency and anaemia in patients with severe aortic stenosis. Open Heart. 2018 Dec 16;5(2):e000901. doi: 10.1136/openhrt-2018-000901. eCollection 2018.'}, {'pmid': '29746650', 'type': 'DERIVED', 'citation': 'Hussain AI, Auensen A, Brunborg C, Beitnes JO, Gullestad L, Pettersen KI. Age-dependent morbidity and mortality outcomes after surgical aortic valve replacement. Interact Cardiovasc Thorac Surg. 2018 Nov 1;27(5):650-656. doi: 10.1093/icvts/ivy154.'}, {'pmid': '28977361', 'type': 'DERIVED', 'citation': 'Auensen A, Hussain AI, Garratt AM, Gullestad LL, Pettersen KI. Patient-reported outcomes after referral for possible valve replacement in patients with severe aortic stenosis. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):129-135. doi: 10.1093/ejcts/ezx228.'}, {'pmid': '26994130', 'type': 'DERIVED', 'citation': 'Hussain AI, Garratt AM, Brunborg C, Aakhus S, Gullestad L, Pettersen KI. Eliciting Patient Risk Willingness in Clinical Consultations as a Means of Improving Decision-Making of Aortic Valve Replacement. J Am Heart Assoc. 2016 Mar 18;5(3):e002828. doi: 10.1161/JAHA.115.002828.'}]}, 'descriptionModule': {'briefSummary': 'Our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to traditional parameters will improve pre-operative risk assessment in patients with AS and better guide patients and doctors in decision whether to operate or not.', 'detailedDescription': 'Patients referred for surgery are included thorough reading referral letter. Data collected in the study wil be compared with data from Medical records and clinical examination.\n\nData entered will be controlled by two investigators.\n\nData wil be compared to national norms and from result of other studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion: Patients above 18 years with symptomatic AS referred to preoperative examination will be included. Patients will undergo standard investigations with regard to assessment of the clinical indication for operation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above 18 years with symptomatic AS referred to preoperative examination.\n\nExclusion Criteria:\n\n* Exclusion: Patients who do not want to participate. Patients not able to speak and read Norwegian.'}, 'identificationModule': {'nctId': 'NCT01794832', 'acronym': 'SAS', 'briefTitle': 'Severe Aortic Stenosis in Patients Referred for Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.', 'orgStudyIdInfo': {'id': 'SAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly with severe aortic stenosis', 'description': 'Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Lars Gullestad, professor', 'role': 'CONTACT', 'email': 'lars.gullestad@medisin.uio.no'}, {'name': 'Amjad Iqbal Hussain', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andreas Auensen, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo University hospital- Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Amjad I Hussain, Md', 'role': 'CONTACT', 'email': 'amhu@ous-hf.no', 'phone': '0047 98043412'}], 'overallOfficials': [{'name': 'Kjell I Pettersen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oslo'}, {'name': 'Amjad I Hussain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hosptial'}, {'name': 'Lars Gullestad, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md', 'investigatorFullName': 'Amjad Iqbal Hussain', 'investigatorAffiliation': 'Oslo University Hospital'}}}}