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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
ClinicalTrials.gov Identifier:
NCT01672203
First received: August 15, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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
CTEPH

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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr. Fikret Er, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT01672203     History of Changes
Other Study ID Numbers: UKK-PostLE
Study First Received: August 15, 2012
Last Updated: August 23, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Embolism
Hypertension, Pulmonary
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014