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Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism

Sponsor
University of Cologne (Other)
Overall Status
Unknown status
CT.gov ID
NCT01672203
Collaborator
(none)
500
Enrollment
1
Location
46
Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The embolus localization during index pulmonary embolism might be of potential relevance for CTEPH development.

    In 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Incidence of CTEPH in Dependence of Thrombus Location in Patients With Acute Pulmonary Embolism and Index Fibrinolysis
    Study Start Date :
    Jan 1, 2009
    Anticipated Primary Completion Date :
    Oct 1, 2012
    Anticipated Study Completion Date :
    Nov 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    PE peripheral with fibrinolysis

    Patients with peripheral PE who received fibrinolysis therapy
    PE peripheral, no fibrinolysis

    Patients with peripheral PE who did not receive fibrinolysis
    PE central with fibrinolysis

    Patients with central PE who received fibrinolysis therapy
    PE central, no fibrinolysis

    Patients with central PE who did not receive fibrinolysis

    Outcome Measures

    Primary Outcome Measures

    1. CTEPH [participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated]

      Incidence of CTEPH

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • acute pulmonary embolism for at least 12 months
    Exclusion Criteria:
    • known pulmonary hypertension other than CTEPH

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart Center of the University Hospital of Cologne Cologne NRW Germany 50937

    Sponsors and Collaborators

    • University of Cologne

    Investigators

    • Principal Investigator: Fikret Er, MD, University of Cologne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Fikret Er, MD, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT01672203
    Other Study ID Numbers:
    • UKK-PostLE
    First Posted:
    Aug 24, 2012
    Last Update Posted:
    Aug 24, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Embolism

    Study Results

    No Results Posted as of Aug 24, 2012