CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation

• Conditions: Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Embolism

• Registration Number: NCT04681014
• Lead Sponsor: iPHNET (italian Pulmonary Hypertension NETwork)

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01-21
• Primary Completion: 2020-07-31
• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1218

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CTEPH-SOLUTION score	24 months	The CTEPH-SOLUTION score will be created on retrospective parameters (i.e., demographic data, diagnostic and clinical information, risk factors, laboratories parameters) collected on pulmonary embolism patients.; The minimum and maximum values will be defined after the multivariate statistical analysis, and the risk factors analyzed a posteriori. Higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
The number of the subject with a diagnosis of CTEPH on the total number of subjects enrolled.	24 months

Trial Locations

Locations (1)

Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I; 🇮🇹 Rome, Italy