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

NCT ID: NCT01672203

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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CTEPH

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PE peripheral with fibrinolysis

Patients with peripheral PE who received fibrinolysis therapy

No interventions assigned to this group

PE peripheral, no fibrinolysis

Patients with peripheral PE who did not receive fibrinolysis

No interventions assigned to this group

PE central with fibrinolysis

Patients with central PE who received fibrinolysis therapy

No interventions assigned to this group

PE central, no fibrinolysis

Patients with central PE who did not receive fibrinolysis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* acute pulmonary embolism for at least 12 months

Exclusion Criteria

* known pulmonary hypertension other than CTEPH
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fikret Er

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fikret Er, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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Heart Center of the University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Fikret Er, MD

Role: CONTACT

Phone: +49-221-478-32396

Email: [email protected]

Natig Gassanov, MD

Role: CONTACT

Phone: +49-221-478-32354

Email: [email protected]

Facility Contacts

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Fikret Er, MD

Role: primary

Other Identifiers

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UKK-PostLE

Identifier Type: -

Identifier Source: org_study_id