Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-28 @ 8:03 AM
Study NCT ID:
NCT00930735
Status:
UNKNOWN
Last Update Posted:
2018-04-23
First Post:
2009-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic Significance of Fibrosis Detection in Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and plasma and myocardium'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2009-06-27', 'studyFirstSubmitQcDate': '2009-06-29', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '3 years'}, {'measure': 'Ventricular arrhythmias', 'timeFrame': '3 years'}, {'measure': 'Unplanned heart failure admissions', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Ejection fraction', 'timeFrame': '3'}, {'measure': 'NYHA status', 'timeFrame': '3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiomyopathy', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34642428', 'type': 'DERIVED', 'citation': 'Vassiliou VS, Pavlou M, Malley T, Halliday BP, Tsampasian V, Raphael CE, Tse G, Vieira MS, Auger D, Everett R, Chin C, Alpendurada F, Pepper J, Pennell DJ, Newby DE, Jabbour A, Dweck MR, Prasad SK. A novel cardiovascular magnetic resonance risk score for predicting mortality following surgical aortic valve replacement. Sci Rep. 2021 Oct 12;11(1):20183. doi: 10.1038/s41598-021-99788-7.'}, {'pmid': '28351901', 'type': 'DERIVED', 'citation': 'Halliday BP, Gulati A, Ali A, Guha K, Newsome S, Arzanauskaite M, Vassiliou VS, Lota A, Izgi C, Tayal U, Khalique Z, Stirrat C, Auger D, Pareek N, Ismail TF, Rosen SD, Vazir A, Alpendurada F, Gregson J, Frenneaux MP, Cowie MR, Cleland JGF, Cook SA, Pennell DJ, Prasad SK. Association Between Midwall Late Gadolinium Enhancement and Sudden Cardiac Death in Patients With Dilated Cardiomyopathy and Mild and Moderate Left Ventricular Systolic Dysfunction. Circulation. 2017 May 30;135(22):2106-2115. doi: 10.1161/CIRCULATIONAHA.116.026910. Epub 2017 Mar 28.'}, {'pmid': '23433931', 'type': 'DERIVED', 'citation': 'Dawson DK, Hawlisch K, Prescott G, Roussin I, Di Pietro E, Deac M, Wong J, Frenneaux MP, Pennell DJ, Prasad SK. Prognostic role of CMR in patients presenting with ventricular arrhythmias. JACC Cardiovasc Imaging. 2013 Mar;6(3):335-44. doi: 10.1016/j.jcmg.2012.09.012. Epub 2013 Feb 20.'}, {'pmid': '22839417', 'type': 'DERIVED', 'citation': 'Dweck MR, Joshi S, Murigu T, Gulati A, Alpendurada F, Jabbour A, Maceira A, Roussin I, Northridge DB, Kilner PJ, Cook SA, Boon NA, Pepper J, Mohiaddin RH, Newby DE, Pennell DJ, Prasad SK. Left ventricular remodeling and hypertrophy in patients with aortic stenosis: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2012 Jul 28;14(1):50. doi: 10.1186/1532-429X-14-50.'}, {'pmid': '21903062', 'type': 'DERIVED', 'citation': 'Dweck MR, Joshi S, Murigu T, Alpendurada F, Jabbour A, Melina G, Banya W, Gulati A, Roussin I, Raza S, Prasad NA, Wage R, Quarto C, Angeloni E, Refice S, Sheppard M, Cook SA, Kilner PJ, Pennell DJ, Newby DE, Mohiaddin RH, Pepper J, Prasad SK. Midwall fibrosis is an independent predictor of mortality in patients with aortic stenosis. J Am Coll Cardiol. 2011 Sep 13;58(12):1271-9. doi: 10.1016/j.jacc.2011.03.064.'}, {'pmid': '20688032', 'type': 'DERIVED', 'citation': "O'Hanlon R, Grasso A, Roughton M, Moon JC, Clark S, Wage R, Webb J, Kulkarni M, Dawson D, Sulaibeekh L, Chandrasekaran B, Bucciarelli-Ducci C, Pasquale F, Cowie MR, McKenna WJ, Sheppard MN, Elliott PM, Pennell DJ, Prasad SK. Prognostic significance of myocardial fibrosis in hypertrophic cardiomyopathy. J Am Coll Cardiol. 2010 Sep 7;56(11):867-74. doi: 10.1016/j.jacc.2010.05.010. Epub 2010 Jun 25."}]}, 'descriptionModule': {'briefSummary': 'The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems and lead to the developement of heart failure\n\nClinical significance Correlation with biomarkers and genetic markers', 'detailedDescription': 'Patients will undergo cardiovascular magnetic resonance (CMR) to include measurement of left ventricular volumes, ejection fraction, detection of inflammation (via STIR sequences) where appropriate, early gadolinium enhancement, late gadolinium enhancement, first pass perfusion using pharmacological stress imaging (contraindications to include comorbidities that do not permit pharmacological stress agents e.g. severe asthma, severe or symptomatic aortic stenosis)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive referrals for CMR from tertiary and nontertiary referral hospitals scanned to evaluate presence and amount of myocardial scarring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of an ischaemic or non-ischaemic cardiomyopathic process\n* no contraindication to contrast enhanced CMR\n* GFR \\>30\n\nExclusion Criteria:\n\n* ESRF\n* Contraindication to CM R'}, 'identificationModule': {'nctId': 'NCT00930735', 'briefTitle': 'The Prognostic Significance of Fibrosis Detection in Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Royal Brompton & Harefield NHS Foundation Trust'}, 'officialTitle': 'The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy', 'orgStudyIdInfo': {'id': '09/0904'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myocardial fibrosis, outcomes', 'description': 'Groups with none and variable amounts of myocardial fibrosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6NP', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sanjay K Prasad, MD', 'role': 'CONTACT', 'email': 'S.Prasad@rbht.nhs.uk', 'phone': '+442073518800'}, {'name': "Rory R O' Hanlon, MD", 'role': 'CONTACT', 'email': "R.O'Hanlon@rbht.nhs.uk", 'phone': '+442073518800'}, {'name': 'Sanjay K Prasad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Sanjay K Prasad, MD', 'role': 'CONTACT', 'email': 's.prasad@rbht.nhs.uk', 'phone': '+442073528121'}, {'name': 'Brian Halliday, MD', 'role': 'CONTACT', 'email': 'b.halliday@rbht.nhs.uk', 'phone': '+442073528121', 'phoneExt': '8812'}], 'overallOfficials': [{'name': 'Sanjay K Prasad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brompton and Harefield Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Sanjay Prasad', 'investigatorAffiliation': 'Royal Brompton & Harefield NHS Foundation Trust'}}}}