Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00325832
Status:
COMPLETED
Last Update Posted:
2010-08-23
First Post:
2006-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Conventional Versus Automated Measurement of Blood Pressure in the Office (The CAMBO Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2010-08-20', 'studyFirstSubmitDate': '2006-05-12', 'studyFirstSubmitQcDate': '2006-05-12', 'lastUpdatePostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ambulatory blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Blood Pressure', 'Systolic Pressure', 'Diastolic Pressure', 'Blood Pressure Monitoring, Ambulatory'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'To determine if the use of automated office blood pressure readings can improve management of systolic hypertension in routine clinical practice. Automated office SBP recordings in routine clinical practice using the BpTRU device will reflect more accurately the mean awake ambulatory systolic BP than will manual BP readings taken with conventional mercury sphygmomanometry. This should lead to improvements in the management of systolic hypertension with optimization of drug therapy in practices using the BpTRU device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Both treated and untreated patients with systolic hypertension under routine FP care\n* For untreated patients, routine office SBP as measured by the patient's FP at the last routine office visit using a mercury device must have SBP ≥ 160 mmHg and DBP \\<= 95 mmHg\n* For patients already receiving antihypertensive therapy, the last routine office BP as measured by the patient's FP using mercury sphygmomanometry must be SBP ≥ 140 mmHg and DBP \\<= 90 mmHg\n\nExclusion Criteria:\n\n* Presence of target organ damage such as MI, stroke, and serum creatinine twice normal\n* Diabetes mellitus treated with insulin or oral hypoglycemic therapy\n* Secondary hypertension\n* Participation in another research study involving measurement of BP\n* Patient's insistence on using self BP measurement outside of the study\n* Any conditions or circumstances which might preclude the successful completion of the study"}, 'identificationModule': {'nctId': 'NCT00325832', 'acronym': 'CAMBO', 'briefTitle': 'Conventional Versus Automated Measurement of Blood Pressure in the Office (The CAMBO Study)', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'orgStudyIdInfo': {'id': '392-2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BpTRU', 'type': 'DEVICE'}, {'name': 'Conventional mercury sphygmomanometry', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Martin Myers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Medical Sciences Centre'}, {'name': 'Sheldon Tobe, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Ontario', 'class': 'OTHER'}]}}}