Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
Study NCT ID:
NCT06784492
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2025-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in cardiac effort', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in cardiac effort is measured as the number of heart beats used during the 6-minute walk test.'}], 'secondaryOutcomes': [{'measure': 'Mean number of health care visits (Health Care Utilization)', 'timeFrame': '3 months', 'description': 'Subject medical records will be reviewed to determine the number of utilizations.'}, {'measure': 'Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score', 'timeFrame': 'baseline and 3 months', 'description': 'The pulmonary embolism quality of life questionnaire ranges from 1 to 27, with higher scores indicating worse outcomes.'}, {'measure': 'Mean change in 6 minute walk distance', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Mean change in activity as measured by Actigraph', 'timeFrame': 'baseline and 3 months', 'description': 'The Actigraph triaxial accelerometer will be used to monitor the amount of activity taken at home on the non-dominant wrist. The accelerometer data will be downloaded and will include the amount of activity.'}, {'measure': 'mean change in diagnoses', 'timeFrame': 'baseline and month 3', 'description': 'Investifators will sum up the number of post-PE syndrome and CTEPH diagnoses and report the mean change in the sum between baseline and month 3.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recovery acute pulmonary embolism', 'Six minute walk', 'Cardiac Effort', 'actigraphy'], 'conditions': ['Acute Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English speaking (\\>18 years old). Daily messages will be sent in English.\n2. Acute PE with at least one of the following:\n\n 1. any right ventricular enlargement or dysfunction on echocardiogram;\n 2. CT Angiogram reporting any right ventricular enlargement; or\n 3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.\n3. Rate controlled atrial arrythmias (resting heart rate \\<110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.\n4. Subjects do need to take prescribed anticoagulation.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Cardiac Effort \\>3.5 beats/m during 6MWT.\n3. Resting tachycardia \\>110 beats/m at hospital discharge.\n4. Chronic Thromboembolic Pulmonary Hypertension\n5. Systolic blood pressure \\>180 mmHg at hospital discharge.\n6. Inability to walk.\n7. Estimated prognosis \\<12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).\n8. Advanced neurologic disease and would not be able to comply with the messages.\n9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.'}, 'identificationModule': {'nctId': 'NCT06784492', 'acronym': 'ERASE-PE', 'briefTitle': 'Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Recovery After Acute Pulmonary Embolism', 'orgStudyIdInfo': {'id': 'STUDY00009895'}, 'secondaryIdInfos': [{'id': '1K23HL171867', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL171867', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Living Intervention-1', 'description': 'Participants who receive daily messages about a healthy intervention.', 'interventionNames': ['Behavioral: Healthy Living Intervention-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Living Intervention-2', 'description': 'Participants who receive daily messages about a different healthy intervention.', 'interventionNames': ['Behavioral: Healthy Living Intervention-2']}], 'interventions': [{'name': 'Healthy Living Intervention-1', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a text or email each day with instructions about a healthy intervention.', 'armGroupLabels': ['Healthy Living Intervention-1']}, {'name': 'Healthy Living Intervention-2', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a text or email each day with instructions about a healthy intervention.', 'armGroupLabels': ['Healthy Living Intervention-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Lachant, DO', 'role': 'CONTACT', 'email': 'Daniel_Lachant@urmc.rochester.edu', 'phone': '585 486 0147'}, {'name': 'Daniel Lachant, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Daniel J Lachant, DO', 'role': 'CONTACT', 'email': 'daniel_lachant@urmc.rochester.edu', 'phone': '5852769357'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Lachant', 'investigatorAffiliation': 'University of Rochester'}}}}