Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-01 @ 1:49 AM
Study NCT ID:
NCT02434159
Status:
UNKNOWN
Last Update Posted:
2015-05-05
First Post:
2015-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-30', 'studyFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walk test', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18, \\<90\n2. Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.\n3. QRS duration \\>120ms on 12 lead ECG\n4. LVEF \\< 35%\n5. LVEDD \\>55 mm\n6. Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.\n\nExclusion Criteria:\n\n1. Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment\n2. Patients who had had an atrial arrhythmia within one month prior to recruitment\n3. Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg\n4. Patients with a heart rate of more than 140 beats per minute\n5. Patients with severe renal failure (eGFR \\< 30)\n6. Patients with a history of allergy to iodine based contrast agents\n7. Predicted life expectancy \\< 1 year\n8. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02434159', 'briefTitle': 'Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy', 'orgStudyIdInfo': {'id': '11/0583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Scan', 'description': 'Heart scan prior to device insertion', 'interventionNames': ['Other: Heart scan']}, {'type': 'NO_INTERVENTION', 'label': 'No scan', 'description': 'No heart scan prior to device insertion'}], 'interventions': [{'name': 'Heart scan', 'type': 'OTHER', 'armGroupLabels': ['Scan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Vanessa Cobb', 'role': 'CONTACT', 'email': 'nesscobb@hotmail.com'}], 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Vanessa Cobb', 'role': 'CONTACT', 'email': 'nesscobb@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}