Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-22 @ 2:01 AM
Study NCT ID:
NCT03916302
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2019-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Embolism WArsaw REgistry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '5-year follow-up', 'timeFrame': '5 years', 'description': 'Patients will be evaluated annually at least during first 5 years after index PE for VTE recurrence and for Post PE syndrome (PPS) including chronic thromboembolic pulmonary hypertension (CTEPH), chronic thromboembolic pulmonary disease (CTEPD), newly diagnosed neoplasms, cardiovascular diseases (coronary artery disease, stroke, heart failure) and functional limitation resulting from psychological sequel of acute PE.'}], 'primaryOutcomes': [{'measure': 'Composite primary outcome', 'timeFrame': 'in-hospital (average of 10 days)', 'description': 'at least one of the following:\n\n1. systolic blood pressure \\< 90 mmHg for at least 15 minutes\n2. need for catecholamine administration because of persistant arterial hypotension or shock\n3. need for mechanical ventilation\n4. need for cardiopulmonary resuscitation'}, {'measure': 'Composite primary outcome', 'timeFrame': 'within 30 days from diagnosis', 'description': 'at least one of the following:\n\n1. systolic blood pressure \\< 90 mmHg for at least 15 minutes\n2. need for catecholamine administration because of persistant arterial hypotension or shock\n3. need for mechanical ventilation\n4. need for cardiopulmonary resuscitation'}], 'secondaryOutcomes': [{'measure': 'Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis', 'timeFrame': 'in-hospital (average of 10 days)', 'description': 'Secondary outcome measure'}, {'measure': 'Major or non-major clinically relevant bleeding defined according to the International Society on Thrombosis and Haemostasis', 'timeFrame': 'within 30 days from diagnosis', 'description': 'Secondary outcome measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute pulmonary embolism'], 'conditions': ['Acute Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': "Initiated in January 2008, The PE-aWARE (Pulmonary Embolism WArsaw REgistry) is an on-going single-centre prospective observational study of patients with confirmed acute pulmonary embolism (APE). Extensive data on consecutive patients with pulmonary embolism is collected and stored. The main objective is to collect and provide information on patients' characteristics, management, and outcome with the purpose of decreasing mortality in APE, the occurrence of bleeding, and the frequency of thromboembolic recurrences. Moreover, the PE-aWARE registry serves as a basis for creating predictive scores for clinicians which aid patient management. The study endpoints comprise clinically recognized (and objectively confirmed) recurrences of PE, major and minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification, need for cardiopulmonary resuscitation or catecholamines, and death.", 'detailedDescription': "The Pulmonary Embolism WArsaw REgistry (PE-aWARE) is an on-going prospective observational study of patients with confirmed acute pulmonary embolism (APE). Carried out since January 2008, the registry includes consecutive patients hospitalized at a single centre. The primary data recorded include details of each patient's clinical status, co-morbidities, the prescribed treatment, the results of additional studies (ie EKG, imaging studies), and the outcome. The study endpoints comprise clinically recognized (and objectively confirmed) recurrences of PE, major and minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification, need for cardiopulmonary resuscitation or catecholamines, and death.\n\nCollecting the fore mentioned data allows for clinicians to better manage the diagnostic workup and treatment and thus facilitates the prevention of possible future complications in APE patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Concecutive patients hospitalized for pulmonary embolism', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* objectively confirmed pulmonary embolism\n* Informed consent for the participation in the study, according to the requirements of the ethics committee\n\nExclusion Criteria:\n\n* lack of consent'}, 'identificationModule': {'nctId': 'NCT03916302', 'acronym': 'PE-aWARE', 'briefTitle': 'Pulmonary Embolism WArsaw REgistry', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Pulmonary Embolism WArsaw REgistry', 'orgStudyIdInfo': {'id': 'PE-aWARE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Complicated outcome', 'description': 'The patients meet at least one of the following criteria:\n\n1. systolic blood pressure \\< 90 mmHg for at least 15 minutes\n2. need for catecholamine administration because of persistant arterial hypotension or shock\n3. need for mechanical ventilation\n4. need for cardiopulmonary resuscitation\n5. bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding).'}, {'label': 'Non-complicated outcome', 'description': 'The patients meet none of the following criteria:\n\n1. systolic blood pressure \\< 90 mmHg for at least 15 minutes\n2. need for catecholamine administration because of persistant arterial hypotension or shock\n3. need for mechanical ventilation\n4. need for cardiopulmonary resuscitation\n5. bleeding classified according to the International Society on Thrombosis and Haemostasis classification (major bleeding and non-major clinically relevant bleeding).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-005', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Piotr Pruszczyk, Prof.', 'role': 'CONTACT', 'email': 'piotr.pruszczyk@wum.edu.pl', 'phone': '00 48 22 502 11 44'}, {'name': 'Marta Z Skowronska, MD', 'role': 'CONTACT', 'email': 'marta.z.kozlowska@gmail.com', 'phone': '00 48 22 502 16 25'}, {'name': 'Piotr Pruszczyk, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marta Z Skowronska, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Piotr Pruszczyk, Prof.', 'role': 'CONTACT', 'email': 'piotr.pruszczyk@wum.edu.pl', 'phone': '00 48 22 502 11 44'}, {'name': 'Marta Z Skowronska, MD', 'role': 'CONTACT', 'email': 'marta.z.kozlowska@gmail.com', 'phone': '00 48 22 502 16 25'}], 'overallOfficials': [{'name': 'Piotr Pruszczyk, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Piotr Pruszczyk', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}