CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation

Evidence-based Detection of CTEPH in Patients With Prior Pulmonary Embolism: Risk Score Evaluation and Validation.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04681014

Acronym

CTEPH-SOLUTION

Enrollment

1218

Registered

2020-12-23

Start date

2016-01-21

Completion date

2022-07-31

Last updated

2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Embolism

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Outcome results