Symptom-related Screening Program Following Pulmonary Embolism for Early Detection of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 646
- Locations
- 16
- Primary Endpoint
- Number of new diagnosis of CTEPH
Study Overview
Brief 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.
Detailed Description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a long-term complication following an acute or silent pulmonary embolism (PE). A history of acute PE was reported in 75% of CTEPH patients. Nevertheless, incidence of CTEPH after a confirmed acute PE vary widely depending of the studies, with estimated incidence from 0.5 to 4%. Performing a follow-up examination of patients diagnosed with acute PE regardless of persisting symptoms and using all available technical procedures is not cost-effective. As a consequence, routine screening for CTEPH after PE is not supported by current evidence and guidelines.
CTEPH is a very disabling and mortal disease, although it is a potential curable disease. However, delayed diagnosis and misdiagnosis is common. Patients are frequently diagnosed with CTEPH at advanced stages of the disease leading to worse clinical outcomes. Early diagnosis of CTEPH is essential, as delay in diagnosis may be associated with a worse prognosis, higher perioperative mortality and inoperable diseases stages. Overall, evidence from various sources suggests that early detection and treatment of CTEPH is advantageous in achieving favorable clinical outcomes. Therefore, there is an important unmet need for early diagnosing this disease.
Focusing diagnostic procedures only on symptomatic patients may be a practical approach for detecting relevant CTEPH.
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.
Objectives
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 year
- •Objectively confirmed diagnosis of acute PE by multidetector CT, V/Q lung scan, or selective pulmonary angiography, according to established diagnostic criteria, with or without symptomatic DVT,
- •Ability of subject to understand the character and consequences of the study,
- •informed consent of the subject.
Exclusion Criteria
- •refused informed consent, inability to cooperation.
Arms & Interventions
Screening
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:
- Pulsioximetry.
- Electrocardiogram.
- Blood sample with determination of NT-ProBNP.
- Echocardiography. Only an echocardiography indicative of PH warrants further evaluation
- V/Q scintigraphy. Possible CTEPH can be assumed when mismatched perfusion defects are detected by VQ scan.
- Right heart catheterization & Pulmonary CT Scan are required for confirming the diagnosis
Intervention: dyspnea grade ≥ II according NYHA-WHO (Diagnostic Test)
Outcomes
Primary Outcomes
Number of new diagnosis of CTEPH
Time Frame: Up 3 years after PE
New diagnosis of CTEPH
Secondary Outcomes
- Derivation of a score to identify high risk population to develop CTEPH(Up 3 years after PE)
- External validation from score to identify patients at risk to develop CTEPH(Up 3 years after PE)
- Number of patients with Chronic Thromboembolic Disease (CTED) after PE(Up 3 years after PE)
Investigators
Luis Jara-Palomares, MD
Principal Investigator
Hospitales Universitarios Virgen del Rocío