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Symptom-related Screening for Early Detection of CTEPH.

NCT03953560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 646

Last updated 2022-03-17

No results posted yet for this study

Summary

Routine screening for Chronic thromboembolic pulmonary hypertension (CTEPH) i after PE is not supported by current evidence and guidelines.

This study aims to evaluate if a screening program for patients with acute PE based on telephone monitoring of symptoms and further examination if only symptomatic patients could help an early detection of CTEPH.

Conditions

Interventions

DIAGNOSTIC_TEST

dyspnea grade ≥ II according NYHA-WHO

Intervention Investigator from each center will recover consecutives PE patients and collect baseline, demographic and comorbidities. In all patients enrolled in the study a short questionnaire regarding dyspnea symptoms will be performed. All patients that refer dyspnea grade ≥ II according NYHA-WHO (6) modified scale will be cited as outpatient to be evaluated Imaging studies and right heart catheterization is the procedure agreeing with the standard care according to current ESC/ERS Guidelines. In all patients, the following tests will be performed: 1. Pulsioximetry. 2. Electrocardiogram. 3. Blood sample with determination of NT-ProBNP. 4. Echocardiography. Only an echocardiography indicative of PH warrants further evaluation 5. V/Q scintigraphy. Possible CTEPH can be assumed when mismatched perfusion defects are detected by VQ scan. 6. Right heart catheterization \& Pulmonary CT Scan are required for confirming the diagnosis

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Sociedad Española de Neumología y Cirugía Torácica

    collaborator OTHER

  • Luis Jara-Palomares, MD

    lead OTHER

Principal Investigators

  • Luis Jara-Palomares, MD · Medical Surgical Unit of Respiratory Diseases, Virgen del Rocio Hospital, CIBERES

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2021-12-31
Completion
2022-02-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03953560 on ClinicalTrials.gov