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Symptom-related Screening for Early Detection of CTEPH.

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ClinicalTrials.gov Identifier: NCT03953560
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Luis Jara-Palomares, MD, Hospitales Universitarios Virgen del Rocío

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.


Condition or disease Intervention/treatment Phase
CTEPH Pulmonary Embolism Symptoms and Signs Dyspnea Diagnostic Test: dyspnea grade ≥ II according NYHA-WHO Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1611 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Design Cohorts study in consecutive patients with objectively confirmed PE.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Symptom-related Screening Program Following Pulmonary Embolism for Early Detection of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH)
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 30, 2020


Arm Intervention/treatment
Experimental: 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:

  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
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




Primary Outcome Measures :
  1. Number of new diagnosis of CTEPH [ Time Frame: Up 3 years after PE ]
    New diagnosis of CTEPH


Secondary Outcome Measures :
  1. External validation from score to identify patients at risk to develop CTEPH [ Time Frame: Up 3 years after PE ]
    external validation from score (Klok FA et al. Derivation of a clinical prediction score for chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. J Thromb Haemost. 2016)

  2. Derivation of a score to identify high risk population to develop CTEPH [ Time Frame: Up 3 years after PE ]
    With variables assocciated to CTEPH investigators will obtain derivation and validation of a score to identify high risk population to develop CTEPH

  3. Number of patients with Chronic Thromboembolic Disease (CTED) after PE [ Time Frame: Up 3 years after PE ]
    Describe the number and clinical characteristics of patients with CTED after PE



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 year
  2. 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,
  3. Ability of subject to understand the character and consequences of the study,
  4. informed consent of the subject.

Exclusion Criteria:

  • refused informed consent, inability to cooperation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953560


Locations
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Spain
Luis Jara-Palomares Recruiting
Sevilla, Seville, Spain, 41014
Contact: Luis Jara-Palomares, MD    667956480    luisoneumo@hotmail.com   
Luis Jara-Palomares Not yet recruiting
Seville, Spain, 41014
Contact: Luis Jara-Palomares, MD    0034667956480 ext 635624    luisoneumo@hotmail.com   
Sponsors and Collaborators
Luis Jara-Palomares, MD

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Responsible Party: Luis Jara-Palomares, MD, Principal Investigator, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT03953560     History of Changes
Other Study ID Numbers: 0034667956480
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be included in RIETE registry. We will done all analyses prestablished and data collected could be used by RIETE investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luis Jara-Palomares, MD, Hospitales Universitarios Virgen del Rocío:
CTEPH
Pulmonary Embolism
Symptoms and Signs
Dyspnea

Additional relevant MeSH terms:
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Embolism
Pulmonary Embolism
Dyspnea
Signs and Symptoms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory