ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01672203
Recruitment Status : Unknown
Verified August 2012 by Dr. Fikret Er, University of Cologne.
Recruitment status was:  Recruiting
First Posted : August 24, 2012
Last Update Posted : August 24, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne

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
CTEPH

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 Type : Observational
Estimated 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 : January 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : November 2012


Group/Cohort
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



Primary Outcome Measures :
  1. CTEPH [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who were hospitalized for acute pulmonary embolism at the University Hospital of Cologne.
Criteria

Inclusion Criteria:

  • acute pulmonary embolism for at least 12 months

Exclusion Criteria:

  • known pulmonary hypertension other than CTEPH

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672203


Contacts
Contact: Fikret Er, MD +49-221-478-32396 fikret.er@uk-koeln.de
Contact: Natig Gassanov, MD +49-221-478-32354 natig.gassanov@uk-koeln.de

Locations
Germany
Heart Center of the University Hospital of Cologne Recruiting
Cologne, NRW, Germany, 50937
Contact: Fikret Er, MD    +49-221-47832396    fikret.er@uk-koeln.de   
Principal Investigator: Fikret Er, MD         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Fikret Er, MD University of Cologne

Responsible Party: Dr. Fikret Er, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT01672203     History of Changes
Other Study ID Numbers: UKK-PostLE
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: August 24, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases