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

NCT01672203 | Unknown DMC

• 1 other identifier: UKK-PostLE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

CTEPH

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• acute pulmonary embolism for at least 12 months

You may not qualify if:

• known pulmonary hypertension other than CTEPH

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Heart Center of the University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Study Officials

• Fikret Er, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fikret Er, MD

CONTACT

+49-221-478-32396; fikret.er@uk-koeln.de

Natig Gassanov, MD

CONTACT

+49-221-478-32354; natig.gassanov@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 24, 2012
• Study Start: January 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

DE (1)