Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01390532
Status:
UNKNOWN
Last Update Posted:
2011-07-11
First Post:
2011-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rest/Stress Quantification Of Left Ventricular Dyssynchrony By 3D Gated Blood Pool D-SPECT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-08', 'studyFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2011-07-08', 'lastUpdatePostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular phase standard deviation.'}], 'secondaryOutcomes': [{'measure': 'Left ventricular entropy'}, {'measure': 'Left ventricle ejection fraction'}, {'measure': 'Quality of life.'}, {'measure': '6-minutes walking test'}]}, 'conditionsModule': {'keywords': ['Left Ventricular Dyssynchrony', 'Gated blood-pool', 'D-SPECT', 'Pharmacological stress', 'NYHA III/IV', 'LVEF < 35 %', 'QRS > 120 ms', 'optimal medical treatment', 'cardiac resynchronization therapy'], 'conditions': ['Left Ventricular Dyssynchrony']}, 'descriptionModule': {'briefSummary': 'Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not clinically improve with CRT. New LVD markers other than QRS duration are needed.\n\nStudy objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) to quantify LVD.', 'detailedDescription': 'Sequential 5 min Gated blood pool D-SPECT acquisition at rest and during last stage of dobutamine and atropin infusion (\\>85% PHR).\n\nRest and stress left ventricular ejection fraction, phase standard deviation and entropy will be determined using a fully automatic commercial software (QBS, Cedars-Sinai, Los Angeles, CA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChronic heart failure with LVEF \\< 35 %, QRS \\> 120 ms, NYHA III/IV, optimal medical therapy for more than one month.\n\n* Patient with stable hemodynamic for more than one month,\n* More than 18-year old man or woman,\n* Patient having given his free, inform and signed consent,\n* Patient place setting by the social security system,\n\nExclusion Criteria:\n\n* Psychiatric disorder\n* Any contra-indication to Technetium,\n* Any contra-indication to dobutamin or atropin\n* Personal or family history of sudden death\n* Previous severe ventricular arrhythmia\n* Obstructive cardiomyopathy, severe aortic stenosis,\n* Pulmonary hypertension,\n* History of renal, lung, hepatic, cardiac transplantation,\n* Pregnant or breast-feeding Woman,\n* Patient who can not conform to the requirements of the protocol,\n* Patient included in another medical study,'}, 'identificationModule': {'nctId': 'NCT01390532', 'briefTitle': 'Rest/Stress Quantification Of Left Ventricular Dyssynchrony By 3D Gated Blood Pool D-SPECT', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT', 'orgStudyIdInfo': {'id': 'CHU-0096'}, 'secondaryIdInfos': [{'id': '2010-A00265-34', 'type': 'REGISTRY', 'domain': '2010-A00265-34'}]}, 'armsInterventionsModule': {'interventions': [{'name': '3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel)', 'type': 'DEVICE', 'description': 'Sequential 5 min Gated blood pool D-SPECT acquisition at rest and during last stage of dobutamine and atropin infusion (\\>85% PHR).\n\nRest and stress left ventricular ejection fraction, phase standard deviation and entropy will be determined using a fully automatic commercial software (QBS, Cedars-Sinai, Los Angeles, CA).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'facility': 'CHU de CLERMONT-FERRAND', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Bernard CITRON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Jean Perrin', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Patrick LACARIN', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}