Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension
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).
Studieoversikt
Status
Detaljert beskrivelse
Rationale
Pulmonary hypertension (PH) post pulmonary thromboembolisms is a serious and complex disease, is one major cause of pulmonary hypertension (1). It is the most feared late complication of pulmonary thromboembolism (PT) characterized by the organization of thrombotic material within the pulmonary arteries (2). Although a purely mechanical theory is too simplistic in view of the lack of correlation between the proportion of obliterated pulmonary arteries and the numbers of PH.
Acute, symptomatic, or asymptomatic PT may be the initial event, but disease progression would result from progressive vascular remodeling of small vessels. It is possible that unresolved pulmonary arterial thrombosis is a decisive factor for vascular endothelial cells to initiate their mesenchymal transition (3).
On the other hand, Pulmonary hypertension post pulmonary thromboembolisms is the only subclass of pulmonary hypertension that has a curative surgical treatment (4). The diagnosis of this situation should be detected as soon as possible to optimize the results of surgical and pharmacological treatment. Surgical indication should be established as early as possible to avoid progression (5).
Hypothesis
The current data on the incidence of PH are very variable, depending on the different studies designs. There are no data on the prognostic of PH in patients with asymptomatic 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. Also we thought and that there are forms of paucisymptomatic PH whose diagnosis and treatment would benefit from a prospective follow-up.
Objectives
Main objective
To know the incidence of pulmonary hypertension (PH) post symptomatic and asymptomatic pulmonary thromboembolic (PT).
The secondary objectives of the study are:
- To defined clinical subtypes of PT with a predictive value of diagnosis of PH in two years.
- To Measure biomarkers described that may be related to the diagnosis of PH or the disease progression.
- Use of genetic, proteomic, RNA transcription, cytometric and cellular and metabolic identification assays to aid in the search for new genetic factors and / or PH biomarkers.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Alava, Spania
- Hospital de Araba
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Barcelona, Spania
- Hospital del Mar
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Gerona, Spania
- Hospital U. de Girona Doctor Josep Trueta
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Granada, Spania
- Hospital U. Virgen de las Nieves
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Madrid, Spania
- Hospital U. La Paz
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Madrid, Spania
- Hospital U. Ramon y Cajal
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Sevilla, Spania
- Hospital San Juan de Dios
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Valladolid, Spania
- Hospital C. U. de Valladolid
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Zaragoza, Spania
- Hospital C. U. Lozano Blesa
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Asturias
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Oviedo, Asturias, Spania
- Hospital U. Central. de Asturias
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Barcelona
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Badalona, Barcelona, Spania
- Hospital M. de Badalona
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Badalona, Barcelona, Spania
- Hospital U. German Trias i Pujol
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Sant Cugat del Valles, Barcelona, Spania
- Hospital G. de Cataluña
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Viladecans, Barcelona, Spania
- Hospital de Viladecans
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Cantabria
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Santander, Cantabria, Spania
- Hospital U. Marques de Valdecilla
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Torrelavega, Cantabria, Spania
- Hospital Sierrallana
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Guipuzcua
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Bilbao, Guipuzcua, Spania
- Hospital de Cruces
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La Rioja
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Logrono, La Rioja, Spania
- Hospital San Pedro
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Madrid
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Alcorcón, Madrid, Spania
- Hospital U. Fundación Alcorcón
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Getafe, Madrid, Spania
- Hospital U. de Getafe
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Navarra
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Pamplona, Navarra, Spania
- Hospital Virgen del Camino
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Sevilla
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Seville, Sevilla, Spania, 41013
- Hospital Virgen del Rocío
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Vizcaya
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Galdacano, Vizcaya, Spania
- Hospital Galdakao-Usansolo
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pulmonary hypertension
Tidsramme: 2 years
|
Diagnosis on pulmonary hypertension after pulmonary thromboembolism
|
2 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Remedios Otero Candelera, Hospital Universitario Virgen del Rocío IBIS
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OSIRIS
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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