Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01672203
Status:
UNKNOWN
Last Update Posted:
2012-08-24
First Post:
2012-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-23', 'studyFirstSubmitDate': '2012-08-15', 'studyFirstSubmitQcDate': '2012-08-23', 'lastUpdatePostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CTEPH', 'timeFrame': 'participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated', 'description': 'Incidence of CTEPH'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['CTEPH']}, 'descriptionModule': {'briefSummary': 'Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for development of CTEPH. It is not known, whether the location of pulmonary embolism (central vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been performed to assess the CTEPH incidence in different populations: in patients with central vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.', 'detailedDescription': 'The embolus localization during index pulmonary embolism might be of potential relevance for CTEPH development.\n\nIn the present study patients with confirmed pulmonary embolism for at least 12 months will be screened for CTEPH. The incidence of CTEPH will be correlated to thrombus location (central vs. peripheral) and the index use of fibrinolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were hospitalized for acute pulmonary embolism at the University Hospital of Cologne.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute pulmonary embolism for at least 12 months\n\nExclusion Criteria:\n\n* known pulmonary hypertension other than CTEPH'}, 'identificationModule': {'nctId': 'NCT01672203', 'briefTitle': 'Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Incidence of CTEPH in Dependence of Thrombus Location in Patients With Acute Pulmonary Embolism and Index Fibrinolysis', 'orgStudyIdInfo': {'id': 'UKK-PostLE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PE peripheral with fibrinolysis', 'description': 'Patients with peripheral PE who received fibrinolysis therapy'}, {'label': 'PE peripheral, no fibrinolysis', 'description': 'Patients with peripheral PE who did not receive fibrinolysis'}, {'label': 'PE central with fibrinolysis', 'description': 'Patients with central PE who received fibrinolysis therapy'}, {'label': 'PE central, no fibrinolysis', 'description': 'Patients with central PE who did not receive fibrinolysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fikret Er, MD', 'role': 'CONTACT', 'email': 'fikret.er@uk-koeln.de', 'phone': '+49-221-47832396'}, {'name': 'Fikret Er, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Heart Center of the University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Fikret Er, MD', 'role': 'CONTACT', 'email': 'fikret.er@uk-koeln.de', 'phone': '+49-221-478-32396'}, {'name': 'Natig Gassanov, MD', 'role': 'CONTACT', 'email': 'natig.gassanov@uk-koeln.de', 'phone': '+49-221-478-32354'}], 'overallOfficials': [{'name': 'Fikret Er, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Fikret Er', 'investigatorAffiliation': 'University of Cologne'}}}}