Pulmonary Hypertension Clinical Trial
Official title:
Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension
NCT number | NCT03134898 |
Other study ID # | OSIRIS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 24, 2013 |
Est. completion date | July 30, 2019 |
Verified date | March 2021 |
Source | Sociedad Española de Neumología y Cirugía Torácica |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 1025 |
Est. completion date | July 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Araba | Alava | |
Spain | Hospital U. Fundación Alcorcón | Alcorcón | Madrid |
Spain | Hospital M. de Badalona | Badalona | Barcelona |
Spain | Hospital U. German Trias i Pujol | Badalona | Barcelona |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital de Cruces | Bilbao | Guipuzcua |
Spain | Hospital Galdakao-Usansolo | Galdacano | Vizcaya |
Spain | Hospital U. de Girona Doctor Josep Trueta | Gerona | |
Spain | Hospital U. de Getafe | Getafe | Madrid |
Spain | Hospital U. Virgen de las Nieves | Granada | |
Spain | Hospital San Pedro | Logrono | La Rioja |
Spain | Hospital U. La Paz | Madrid | |
Spain | Hospital U. Ramón y Cajal | Madrid | |
Spain | Hospital U. Central. de Asturias | Oviedo | Asturias |
Spain | Hospital Virgen del Camino | Pamplona | Navarra |
Spain | Hospital G. de Cataluña | Sant Cugat del Valles | Barcelona |
Spain | Hospital U. Marqués de Valdecilla | Santander | Cantabria |
Spain | Hospital San Juan de Dios | Sevilla | |
Spain | Hospital Virgen del Rocío | Seville | Sevilla |
Spain | Hospital Sierrallana | Torrelavega | Cantabria |
Spain | Hospital C. U. de Valladolid | Valladolid | |
Spain | Hospital de Viladecans | Viladecans | Barcelona |
Spain | Hospital C. U. Lozano Blesa | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Sociedad Española de Neumología y Cirugía Torácica |
Spain,
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. — View Citation
Galiè N, Kim NH. Pulmonary microvascular disease in chronic thromboembolic pulmonary hypertension. Proc Am Thorac Soc. 2006 Sep;3(7):571-6. Review. — View Citation
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. Review. — View Citation
Lang IM. Chronic thromboembolic pulmonary hypertension--not so rare after all. N Engl J Med. 2004 May 27;350(22):2236-8. — View Citation
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: 2008/25/smw-11915. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary hypertension | Diagnosis on pulmonary hypertension after pulmonary thromboembolism | 2 years |
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