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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by University of Cologne.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne Identifier:
First received: August 15, 2012
Last updated: August 23, 2012
Last verified: August 2012
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.


Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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

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.


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.

Inclusion Criteria:

  • acute pulmonary embolism for at least 12 months

Exclusion Criteria:

  • known pulmonary hypertension other than CTEPH
  Contacts and Locations
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Please refer to this study by its identifier: NCT01672203

Contact: Fikret Er, MD +49-221-478-32396
Contact: Natig Gassanov, MD +49-221-478-32354

Heart Center of the University Hospital of Cologne Recruiting
Cologne, NRW, Germany, 50937
Contact: Fikret Er, MD    +49-221-47832396   
Principal Investigator: Fikret Er, MD         
Sponsors and Collaborators
University of Cologne
Principal Investigator: Fikret Er, MD University of Cologne
  More Information

Responsible Party: Dr. Fikret Er, MD, University of Cologne Identifier: NCT01672203     History of Changes
Other Study ID Numbers: UKK-PostLE
Study First Received: August 15, 2012
Last Updated: August 23, 2012

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases processed this record on April 27, 2017