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

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

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 Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50937
      • Recruiting
      • Heart Center of the University Hospital of Cologne
      • Contact: Fikret Er, MD; Phone Number: +49-221-47832396; Email: fikret.er@uk-koeln.de
      • Principal Investigator: Fikret Er, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who were hospitalized for acute pulmonary embolism at the University Hospital of Cologne.

Description

Inclusion Criteria:

• acute pulmonary embolism for at least 12 months

Exclusion Criteria:

• known pulmonary hypertension other than CTEPH

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: August 15, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Estimate): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Embolism
• Other Study ID Numbers: UKK-PostLE