Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-03-02 @ 10:11 PM
Study NCT ID:
NCT02368158
Status:
UNKNOWN
Last Update Posted:
2015-09-16
First Post:
2015-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-15', 'studyFirstSubmitDate': '2015-02-04', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrocardiography (ECG)', 'timeFrame': '30 minutes', 'description': 'determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test'}, {'measure': 'Breathing rate (BR)', 'timeFrame': 'every 5 minutes for 30 minutes', 'description': 'determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test'}, {'measure': 'Heart rate (HR)', 'timeFrame': 'every 5 minutes for 30 minutes', 'description': 'determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test'}, {'measure': 'Blood pressure', 'timeFrame': 'every 5 minutes for 30 minutes', 'description': 'determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test'}, {'measure': 'oxygen saturation', 'timeFrame': '30 minutes', 'description': 'determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test'}, {'measure': 'mean deviation of baseline lane', 'timeFrame': '30 minutes', 'description': 'determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test'}, {'measure': 'mean reaction time', 'timeFrame': '30 minutes', 'description': 'determination of predictors of fitness of driving a car in cardiologic patients in rehabilitation and acute clinic via comparison of medical data such as ECG, heart rate, breathing rate, oxygen saturation to quality of driving data via Lane Change Test'}], 'secondaryOutcomes': [{'measure': 'heart rate (HR)', 'timeFrame': 'every 5 minutes for 30 minutes', 'description': 'feasibility of automotive monitoring of heart and breathing rate via contactless camera'}, {'measure': 'Breathing rate', 'timeFrame': 'every 5 minutes for 30 minutes', 'description': 'feasibility of automotive monitoring of heart and breathing rate via contactless camera'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myocard infarction', 'arrhythmia', 'fitness of driving'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'In this study predictors of fitness to drive a car in cardiologic patients after acute intervention and discharge from hospital to home or rehabilitation are determined in addition to possible automotive monitoring of vital signs via contact less sensors.', 'detailedDescription': 'Increasing numbers of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to fitness of driving after their discharge from hospital to home or rehabilitation. A policy paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience but only little trial data.Therefore predictors of reduced fitness to drive a car are determined via medical data in comparison to data elevated while "driving" in a simulator and evaluated via Lane Change Test (LCT). Also monitoring of the fitness of driving in the car, automotive monitoring via contactless sensors, could be helpful for judgement.Therefore possible evaluation of heart and breathing rate will be examined with contactless measurements via video camera.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation)\n* rehabilitation in clinic "An der Rosenquelle"\n\nExclusion Criteria:\n\n* dementia\n* lack of language ability\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02368158', 'acronym': 'RehaDrive', 'briefTitle': 'Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients in Rehabilitation and Acute Clinic and Contactless Determination of Vital Signs Via Camera', 'orgStudyIdInfo': {'id': 'CTC-A 13-095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiologic Patient', 'description': 'Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors', 'interventionNames': ['Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors']}, {'type': 'EXPERIMENTAL', 'label': 'Control Proband', 'description': 'The same intervention as in arm "cardiologic patients" :Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors', 'interventionNames': ['Other: Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors']}], 'interventions': [{'name': 'Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors', 'type': 'OTHER', 'description': 'During a driving simulation medical data are elevated such as electrocardiography (ECG), heart rate breathing rate and oxygen saturation and compared to data of the performed Lane Change Test as a measurement for the quality of driving. Hereby the deviation of the lane from baseline during driving and ordered lane change via signs are determined also when performing cognitive and visual tasks. Also the simulation is simultaneously accompanied by monitoring via contactless camera usage in regard to possible determination of heart and breathing rate according to Eulerian Magnification Method', 'armGroupLabels': ['Cardiologic Patient', 'Control Proband']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52066', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Erik Skobel, MD', 'role': 'CONTACT', 'email': 'erik.skobel@rosenquelle.de', 'phone': '+49 241 6007', 'phoneExt': '501'}, {'name': 'Sigrid Gloeggler, M.Sc.', 'role': 'CONTACT', 'email': 'sgloeggler@ukaachen.de', 'phone': '+49 241 80', 'phoneExt': '35226'}], 'facility': 'Clinic of Rehabilitation "An der Rosenquelle"', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Reith, MD', 'role': 'CONTACT', 'email': 'sreith@ukaachen.de', 'phone': '+49 241 80', 'phoneExt': '35170'}, {'name': 'Sigrid Gloeggler, M.Sc-', 'role': 'CONTACT', 'email': 'sgloeggler@ukaachen.de', 'phone': '+49 241 80', 'phoneExt': '35226'}, {'name': 'Sebastian Reith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Sebastian Reith, MD', 'role': 'CONTACT', 'email': 'sreith@ukaachen.de', 'phone': '+49 241 80', 'phoneExt': '35170'}, {'name': 'Sigrid Gloeggler, M.Sc.', 'role': 'CONTACT', 'email': 'sgloeggler@ukaachen.de', 'phone': '+49 241 80', 'phoneExt': '35226'}], 'overallOfficials': [{'name': 'Sebastian Reith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Angiology, Pneumology and Intensive Medicine, RWTH Aachen University Hospital'}, {'name': 'Skobel Erik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehabilitation Clinic "Ander Rosenquelle", Kurbrunnenstreet 5, 52066 Aachen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Electronics Nederland B.V. acting through Philips CTO organization', 'class': 'INDUSTRY'}, {'name': 'RWTH Aachen Germany Institut fuer Kraftfahrzeuge (IKA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}