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

CTEPH Clinical Trial

Official title:

Incidence of CTEPH in Dependence of Thrombus Location in Patients With Acute Pulmonary Embolism and Index Fibrinolysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01672203
• Other study ID #: UKK-PostLE
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2012
• Last updated: August 23, 2012
• Start date: January 2009
• Est. completion date: November 2012

Study information

• Verified date: August 2012
• Source: University of Cologne
• Contact: Fikret Er, MD
• Phone: +49-221-478-32396
• Email: fikret.er[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• acute pulmonary embolism for at least 12 months

Exclusion Criteria:

• known pulmonary hypertension other than CTEPH

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• CTEPH

Locations

Country	Name	City	State
Germany	Heart Center of the University Hospital of Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTEPH	Incidence of CTEPH	participants will be followed at least one year after acute pulmonary embolism, an expected average of 5 years follow-up is estimated	No