NCT03953560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
646

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

May 14, 2019

Last Update Submit

March 16, 2022

Conditions

CTEPHPulmonary EmbolismSymptoms and SignsDyspnea

Keywords

CTEPHPulmonary EmbolismSymptoms and SignsDyspnea

Outcome Measures

Primary Outcomes (1)

  • Number of new diagnosis of CTEPH

    New diagnosis of CTEPH

    Up 3 years after PE

Secondary Outcomes (3)

  • External validation from score to identify patients at risk to develop CTEPH

    Up 3 years after PE

  • Derivation of a score to identify high risk population to develop CTEPH

    Up 3 years after PE

  • Number of patients with Chronic Thromboembolic Disease (CTED) after PE

    Up 3 years after PE

Study Arms (1)

Screening

EXPERIMENTAL

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

Interventions

dyspnea grade ≥ II according NYHA-WHODIAGNOSTIC_TEST

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

Screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • refused informed consent, inability to cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hospital Universitario Puerto Real

Puerto Real, Cadiz, Spain

Location

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellon, Spain

Location

Hospital de Galdakao

Galdakao, Vizcaya, Spain

Location

Hospital General Universitario de Albacete

Albacete, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Spain

Location

Parc Sanitari Sant Joan de Deu

Barcelona, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Virgen de la Luz

Cuenca, Spain

Location

Hospital General Universitario de Elche

Elche, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Virgen del Rocio

Seville, 41014, Spain

Location

Hospital Universitario Joan XXIII de Tarragona

Tarragona, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Related Publications (1)

  • Marin-Romero S, Ballaz-Quincoces A, Gomez-Cuervo C, Marchena-Yglesias PJ, Lopez-Miguel P, Francisco-Albesa I, Pedrajas-Navas JM, Lumbierres M, Aibar-Arregui MA, Bosco Lopez-Saez J, Perez-Pinar M, Baeza-Martinez C, Riera-Mestre A, Peris-Sifre M, Porras-Ledantes JA, Criado-Garcia J, Elias-Hernandez T, Otero R, Barca-Hernando M, Muriel A, Klok FA, Jara-Palomares L; SYSPPE investigators. Symptom-related screening programme for early detection of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism: the SYSPPE study. Thorax. 2024 Jan 18;79(2):144-152. doi: 10.1136/thorax-2023-220580.

    PMID: 38050187DERIVED

MeSH Terms

Conditions

Pulmonary EmbolismSigns and SymptomsDyspnea

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, Respiratory

Study Officials

  • Luis Jara-Palomares, MD

    Medical Surgical Unit of Respiratory Diseases, Virgen del Rocio Hospital, CIBERES

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Design Cohorts study in consecutive patients with objectively confirmed PE.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

January 16, 2019

Primary Completion

December 31, 2021

Study Completion

February 15, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Data will be included in RIETE registry. We will done all analyses prestablished and data collected could be used by RIETE investigators

Locations

ES(16)