Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-26 @ 12:09 PM
Study NCT ID:
NCT04675957
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Rehab Retrospective Review (CR3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2020-10-19', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Arrhythmias (as recorded by clinic or WCD)', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data on Arrhythmias captured via WCD or Surface ECG will be collected:\n\n* Atrial tachycardia\n* Ventricular tachycardia\n* Bradycardia'}, {'measure': 'Number of adequate WCD alarms (as recorded by WCD) per patient', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of adequate WCD alarms will be recorded'}, {'measure': 'Number of inadequate WCD alarms (as recorded by WCD) per patient', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inadequate WCD alarms will be recorded'}, {'measure': 'Number of patients with appropriate WCD Shocks', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of appropriate WCD shocks will be collected.'}, {'measure': 'Number of patients with Syncopes/Presyncopes', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, data of Syncopes or Pre-Syncopes will be collected.'}, {'measure': 'Number of patients with abnormal blood pressure (measured in mmHg)', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data for abnormal blood pressure will be collected:\n\n* Occurrence of Hypotension\n* Occurrence of Hypertension'}, {'measure': 'Number of other issues with WCD', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, every data with an issue with WCD disturbing the normal rehabilitation activities will be collected.'}, {'measure': 'Number of other Adverse Events', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, other adverse events recorded by staff during therapy session that stopped ET session (notWCD specific) will be collected.'}, {'measure': 'Number of patients with inappropriate WCD Shocks', 'timeFrame': '3 months', 'description': 'To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inappropriate WCD shocks (captured via LifeVestNetwork) will be collected.'}], 'secondaryOutcomes': [{'measure': 'Difference in physical exercise capacity - measured in METs', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.'}, {'measure': 'Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.'}, {'measure': 'Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.'}, {'measure': 'Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.'}, {'measure': 'Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.'}, {'measure': 'Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.\n\nWith echocardiography the left ventricular ejection fraction (%) will be collected.'}, {'measure': 'Left ventricular end diastolic diameter (measured in mm)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.\n\nWith Echocardiography Left ventricular end diastolic diameter (mm) will be collected.'}, {'measure': 'Size of the Left atrial (measured in mm)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.\n\nWith Echocardiography. the size of the Left atrial (mm) will be collected.'}, {'measure': 'Right atrial diameter (measured in mm)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.\n\nWith Echocardiography, Right atrial diameter (mm) will be collected.'}, {'measure': 'diastolic dysfunction (measured in grade)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.\n\nWith Echocardiography, the diastolic dysfunction (grade) will be collected.'}, {'measure': 'Intraventricular septum (diastolic, measured in mm)', 'timeFrame': '3 months', 'description': 'The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.\n\nWith Echocardiography, the Intraventricular septum (diastole, mm) will be collected.'}, {'measure': 'Heart rate derived from the WCD (measured in beats per Minute)', 'timeFrame': '3 months', 'description': "The correlation of WCD-derived parameters such as heart rate with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses."}, {'measure': 'Body Position derived from the WCD', 'timeFrame': '3 months', 'description': "The correlation of WCD-derived parameters such as body position with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses. Body position is measured by position sensors."}, {'measure': 'Step count derived from the WCD (steps/day)', 'timeFrame': '3 months', 'description': "The correlation of WCD-derived parameters such as the step count with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wearable cardioverter-defibrillator', 'cardiac rehabilitation'], 'conditions': ['Sudden Cardiac Death', 'Heart Failure', 'Ventricular Arrythmia', 'Ventricular Tachycardia', 'Ventricular Fibrillation']}, 'referencesModule': {'references': [{'pmid': '38032261', 'type': 'DERIVED', 'citation': 'Rohrer U, Reischl A, Manninger M, Binder RK, Fiedler L, Gruska M, Altenberger J, Dorr A, Steinwender C, Stuehlinger M, Wonisch M, Zirngast B, Zweiker D, Zirlik A, Scherr D; Austrian WCD Study Group. Cardiovascular Rehabilitation With a WCD-Data From the CR3 Study (Cardiac Rehab Retrospective Review). J Cardiopulm Rehabil Prev. 2024 Mar 1;44(2):115-120. doi: 10.1097/HCR.0000000000000832. Epub 2023 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients.\n\nSpecifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Austrian patients with a WCD having the TRENDS feature who underwent cardiac rehabilitation from 2014-18 will be retrospectively analyzed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prescribed WCD as part of the Austrian WCD registry population from 2014-2018\n* Partial (\\>50%) or full completion of a rehabilitation program when wearing the WCD in Austria\n* ≥18 years old and able to give informed consent\n\nExclusion Criteria:\n\n\\- none'}, 'identificationModule': {'nctId': 'NCT04675957', 'acronym': 'CR3', 'briefTitle': 'Cardiac Rehab Retrospective Review (CR3)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Cardiac Rehab Retrospective Review (CR3)', 'orgStudyIdInfo': {'id': '90D0204'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cardiac rehabilitation', 'type': 'OTHER', 'description': 'stationary or ambulatory cardiac rehabilitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Daniel Scherr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}