Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-01 @ 7:03 PM
Study NCT ID:
NCT01796704
Status:
UNKNOWN
Last Update Posted:
2013-02-22
First Post:
2013-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index With the Clinical Evaluation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular reserve index', 'timeFrame': '1 day', 'description': 'CVRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['functional capacity', 'NYHA class'], 'conditions': ['Healthy', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable.\n\nHigh reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.\n\nThe reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit.\n\nIn this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit.', 'detailedDescription': 'The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable and continuously monitored by a physiological control (reserve control)not yet discovered.\n\nHigh reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.\n\nThe reserve is decreased reversibly with aerobic activity and may reach an exhaustion threshold in which the assumed reserve control induces a reversible fatigue and dyspnea which dissolve once the activity decreased.\n\nThe reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit (composed of blood pressure, heart rate, respiratory rate, central venous pressure or its estimation, weight, height and gender.\n\nIn this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit (cross sectional comparison).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of adults both genders:\n\nhealthy subjects visiting for administrative cause healthy subject during acute illness patients with chronic conditions', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult informed consent\n\nExclusion Criteria:\n\n* an emergency case'}, 'identificationModule': {'nctId': 'NCT01796704', 'briefTitle': 'Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index With the Clinical Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index (Calculated From Physiological Parameters) With the Clinical Evaluation', 'orgStudyIdInfo': {'id': 'COM120018CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy and mild heart failure', 'description': 'diversity of patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55900', 'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'Uri Gabbay, MD', 'role': 'CONTACT', 'email': 'urigab@clalit.org.il', 'phone': '+972-3-5343736'}, {'name': 'Merav Gabbay, MD', 'role': 'CONTACT', 'email': 'meravgb@clalit.org.il', 'phone': '+972-3-5343736'}, {'name': 'Uri Gabbay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Independent physician Clinic Clalit Health Services', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Uri Gabbay, M.D, M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}