CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation

NCT04681014 | Unknown DMC

• 1 other identifier: CTEPH-SOLUTION
• Study Type: observational
• Target: 1,218
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of the subject with a diagnosis of CTEPH on the total number of subjects enrolled.

  24 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• patients without pulmonary embolism diagnosis

Sponsors & Collaborators

• iPHNET (italian Pulmonary Hypertension NETwork): lead

Study Sites (1)

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

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: January 21, 2016
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2022
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

IT (1)