Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-04-15 @ 12:58 PM
Study NCT ID:
NCT02220569
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PhysioFlow to Detect Cardiotoxicity in Chemo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing the change in ejection fraction measured by physioflow and MUGA scan', 'timeFrame': 'at initial diagnosis and after 3 month'}], 'secondaryOutcomes': [{'measure': 'acceptance score on the five-point Likert Scale to measure tolerability', 'timeFrame': 'up to 24 hrs', 'description': 'At the end of physioflow and or MUGA scan, a questionnaire to assess acceptance was proposed to all patients. The following aspects were evaluated: preparation and information before the imaging examination, degree of preceding concern, comfort, helplessness during the examination, pain experienced, degree of overall satisfaction. Evaluation was performed with a five-point qualitative Likert scale: very low, low, moderate, high, very high'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chemotherapy, Cancer, Cardiotoxicity, Physioflow']}, 'descriptionModule': {'briefSummary': 'PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving chemotherapy early on in order to avoid irreversible damage. In addition to that, we will test if the PhysioFlow is non-inferior to the conventional MUGA scan.', 'detailedDescription': 'Our objective is to compare the PhysioFlow to the MUGA scan and see if the results are statistically the same using both techniques. This is what is known as a non-inferior study. The advantage of PhysioFlow is that it is non-invasive, fast and it is done at the bedside or while the patient is receiving his or her chemotherapy.\n\nThe patient will be tested with the MUGA scan, as per the standard of care, before chemotherapy is initiated and at every 3 months. The patient will also be tested with the PhysioFlow at the same dates of the MUGA scan. In addition to that, the patients will be tested at each chemotherapy cycle with the PhysioFlow.\n\nShould the PhysioFlow indicate the patient has a cardiac toxicity as the patient is receiving chemotherapy, the results will be confirmed with the MUGA scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving chemotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age above 18 years old\n2. Histologically confirmed diagnosis of cancer\n3. ECOG 0 to 2\n4. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained\n5. Able to adhere to the study visit schedule and other protocol requirements\n\nControl Group\n\n1. Age above 18 years old\n2. No previous history of cancer\n3. ECOG 0 to 2\n4. Did not receive chemotherapeutic agents (even if outside the context of cancer)\n5. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained\n6. Able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n1. Age less than 18 years\n2. ECOG 3-4\n3. Suspected or proven severe aortic insufficiency\n4. Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting device)\n5. Congenital cardiac deformities ,such as septal defects\n6. Refuse to comply with the specified visit schedules and requirements'}, 'identificationModule': {'nctId': 'NCT02220569', 'acronym': 'PULSE-ECCho', 'briefTitle': 'PhysioFlow to Detect Cardiotoxicity in Chemo', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy', 'orgStudyIdInfo': {'id': '4073'}}, 'contactsLocationsModule': {'locations': [{'zip': 'h3a 1a1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'email': 'ralph-maroun@hotmail.com', 'phone': '5147080701'}, {'name': 'Ralph Maroun', 'role': 'CONTACT'}, {'name': 'Nathaniel Bouganim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McGill university health center, Royal Victoria hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'h4a 1v3', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ralph Maroun, MD', 'role': 'CONTACT', 'email': 'ralph-maroun@hotmail.com', 'phone': '5147080701'}, {'name': 'Nathaniel Bouganim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Ralph Maroun, M.D.', 'role': 'CONTACT', 'email': 'ralph.maroun@mail.mcgill.ca', 'phone': '5147080701'}], 'overallOfficials': [{'name': 'Nathaniel Bouganim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc', 'investigatorFullName': 'Nathaniel Bouganim', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}