CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation

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

1218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-21

Study Completion Date

2022-07-31

Brief Summary

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CTEPH-SOLUTION aims to create a risk score for the early detection of Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH) among patients with previous pulmonary embolism.

The risk score, created on retrospective data, will be validated on newly diagnosed pulmonary embolism patients.

Detailed Description

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CTEPH-SOLUTION is a multicenter observational cross-sectional and prospective study in patients with a prior and new diagnosis of pulmonary embolism.

Patients with prior pulmonary embolism will be screened at baseline with doppler echocardiography: an estimated sPAP ≥ 40 mmHg will be the indication for pulmonary hypertension detection. After 24 months from baseline, patients will be followed-up for CTEPH detection. CTEPH diagnosis will be carried out according to the current ESC/ERS guidelines.

Incident (pulmonary embolism episode at least three months before the baseline) and prevalent (pulmonary embolism episode) patients will be enrolled.

Conditions

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Chronic Thromboembolic Pulmonary Hypertension Pulmonary Embolism

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 at baseline evaluation
* Diagnosis of prior (\> 30 days from pulmonary embolism onset) or new-onset pulmonary embolism, according to the ESC guidelines on the diagnosis and management of acute pulmonary embolism

Exclusion Criteria

* patients without pulmonary embolism diagnosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CTEPH-SOLUTION

Identifier Type: -

Identifier Source: org_study_id