Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension

NCT03134898 | Completed

• 1 other identifier: OSIRIS
• Study Type: observational
• Target: 1,025
• Locations: 1 country
• Sites: 23

Brief Summary

The current data on the incidence of pulmonary hypertension (PH) are very variable, depending on the different studies designs. There are no data on the prognostic of PH in patients with asymptomatic pulmonary thromboembolisms (PT), neither paucisymptomatic PH, in which without a prospective follow-up would be underdiagnosed. We thought that the prognosis of both clinical forms (PT with or without symptoms) would be similar. The objective of this study is know the real incidence of pulmonary hypertension (PH) post symptomatic and asymptomatic pulmonary thromboembolic (PT).

Conditions

Pulmonary Hypertension; Pulmonary Thromboembolisms

Outcome Measures

Primary Outcomes (1)

• Pulmonary hypertension

  Diagnosis on pulmonary hypertension after pulmonary thromboembolism

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with diagnosis of incidental or symptomatic pulmonary thromboembolisms

You may qualify if:

• Patients 18 years or older and able to provide informed consent
• Diagnosis of pulmonary thromboembolisms confirmed by
• Computed Tomography Angiography (CTA) if there are a partial transluminal defect surrounded by contrast or a complete occlusion of pulmonary artery.
• Pulmonary ventilation/perfusion scan.- Patients with high risk based on PIOPED study criteria or in patients with deep venous thrombosis confirmed by echography and positron emission tomography (PET) scan not concluding.

You may not qualify if:

• Any contraindication to the performance of the pulmonary hypertension diagnostic tests
• Any circumstance, to investigator criteria, to impede the patient follow up
• Life expectancy lower than 6 months

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (23)

Hospital M. de Badalona

Badalona, Barcelona, Spain

Location

Hospital U. German Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital G. de Cataluña

Sant Cugat del Vallès, Barcelona, Spain

Location

Hospital de Viladecans

Viladecans, Barcelona, Spain

Location

Hospital U. Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Sierrallana

Torrelavega, Cantabria, Spain

Location

Hospital de Cruces

Bilbao, Guipuzcua, Spain

Location

Hospital San Pedro

Logroño, La Rioja, Spain

Location

Hospital U. Fundación Alcorcón

Alcorcón, Madrid, Spain

Location

Hospital U. de Getafe

Getafe, Madrid, Spain

Location

Hospital Virgen del Camino

Pamplona, Navarre, Spain

Location

Hospital U. Central. de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, Spain

Location

Hospital de Araba

Alava, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital U. de Girona Doctor Josep Trueta

Girona, Spain

Location

Hospital U. Virgen de las Nieves

Granada, Spain

Location

Hospital U. La Paz

Madrid, Spain

Location

Hospital U. Ramón y Cajal

Madrid, Spain

Location

Hospital San Juan de Dios

Seville, Spain

Location

Hospital C. U. de Valladolid

Valladolid, Spain

Location

Hospital C. U. Lozano Blesa

Zaragoza, Spain

Location

Related Publications (6)

• Tueller C, Stricker H, Soccal P, Tamm M, Aubert JD, Maggiorini M, Zwahlen M, Nicod L; Swiss Society for Pulmonary Hypertension. Epidemiology of pulmonary hypertension: new data from the Swiss registry. Swiss Med Wkly. 2008 Jun 28;138(25-26):379-84. doi: 10.4414/smw.2008.11915.

  PMID: 18587690 BACKGROUND

• Lang IM. Chronic thromboembolic pulmonary hypertension--not so rare after all. N Engl J Med. 2004 May 27;350(22):2236-8. doi: 10.1056/NEJMp048088. No abstract available.

  PMID: 15163772 BACKGROUND

• Humbert M. Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: pathophysiology. Eur Respir Rev. 2010 Mar;19(115):59-63. doi: 10.1183/09059180.00007309.

  PMID: 20956167 BACKGROUND

• Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Hodgkins D, Goldsmith K, Hughes RJ, Sheares K, Tsui SS, Armstrong IJ, Torpy C, Crackett R, Carlin CM, Das C, Coghlan JG, Pepke-Zaba J. Improved outcomes in medically and surgically treated chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med. 2008 May 15;177(10):1122-7. doi: 10.1164/rccm.200712-1841OC. Epub 2008 Feb 21.

  PMID: 18292468 BACKGROUND

• Galie N, Kim NH. Pulmonary microvascular disease in chronic thromboembolic pulmonary hypertension. Proc Am Thorac Soc. 2006 Sep;3(7):571-6. doi: 10.1513/pats.200605-113LR.

  PMID: 16963536 BACKGROUND

• Otero R, Lobo JL, Lopez R, Fernandez C, Jimenez D, Muriel A, Alfonso M, Ballaz A, Nunez-Ares A, Rodriguez-Matute C, de Miguel-Diez J, Rodriguez-Chiaradia DA, Alcalde M, Elias T, Jara-Palomares L, Rivas A, Alonso A, Garcia-Ortega A, Sancho T, Morillo R, Garcia-Bragado F, Hernandez-Blasco L, Uresandi F, Madridano O, Aguero R, Monreal M; OSIRIS Investigators. Feasibility of a screening algorithm for chronic thromboembolic pulmonary hypertension: The OSIRIS study. Thromb Res. 2023 Aug;228:1-9. doi: 10.1016/j.thromres.2023.05.005. Epub 2023 May 19.

  PMID: 37263121 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Remedios Otero Candelera

  Hospital Universitario Virgen del Rocío IBIS

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ferran Barbé

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: November 24, 2013
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (23)