CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation (CTEPH-SOLUTION)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Embolism; Chronic Thromboembolic Pulmonary Hypertension

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 Type: Observational
• Enrollment (Actual): 1218

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with prior pulmonary embolism followed by centres for anticoagulant therapy management (TAO centres) will be enrolled by the investigator's centres and undergo baseline evaluation for prevalent CTEPH detection; al CTEPH will be confirmed by right heart catheterization.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: iPHNET (italian Pulmonary Hypertension NETwork)

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2016
• Primary Completion (Actual): July 31, 2020
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Hypertension; Embolism; Hypertension, Pulmonary; Pulmonary Embolism
• Other Study ID Numbers: CTEPH-SOLUTION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No