CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation

Pulmonary Embolism Clinical Trial

— CTEPH-SOLUTION  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04681014
• Other study ID #: CTEPH-SOLUTION
• Status: Active, not recruiting
• Start date: January 21, 2016
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2020
• Source: iPHNET (italian Pulmonary Hypertension NETwork)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1218
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Embolism
• Hypertension, Pulmonary
• Pulmonary Embolism

Locations

Country	Name	City	State
Italy	Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
iPHNET (italian Pulmonary Hypertension NETwork)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTEPH-SOLUTION score	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.	24 months
Secondary	The number of the subject with a diagnosis of CTEPH on the total number of subjects enrolled.		24 months