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).
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Alava、スペイン
- Hospital de Araba
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Barcelona、スペイン
- Hospital del Mar
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Gerona、スペイン
- Hospital U. de Girona Doctor Josep Trueta
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Granada、スペイン
- Hospital U. Virgen de las Nieves
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Madrid、スペイン
- Hospital U. La Paz
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Madrid、スペイン
- Hospital U. Ramón y Cajal
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Sevilla、スペイン
- Hospital San Juan de Dios
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Valladolid、スペイン
- Hospital C. U. de Valladolid
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Zaragoza、スペイン
- Hospital C. U. Lozano Blesa
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Asturias
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Oviedo、Asturias、スペイン
- Hospital U. Central. de Asturias
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Barcelona
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Badalona、Barcelona、スペイン
- Hospital M. de Badalona
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Badalona、Barcelona、スペイン
- Hospital U. German Trias i Pujol
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Sant Cugat del Valles、Barcelona、スペイン
- Hospital G. de Cataluña
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Viladecans、Barcelona、スペイン
- Hospital de Viladecans
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Cantabria
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Santander、Cantabria、スペイン
- Hospital U. Marques de Valdecilla
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Torrelavega、Cantabria、スペイン
- Hospital Sierrallana
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Guipuzcua
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Bilbao、Guipuzcua、スペイン
- Hospital de Cruces
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La Rioja
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Logrono、La Rioja、スペイン
- Hospital San Pedro
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Madrid
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Alcorcón、Madrid、スペイン
- Hospital U. Fundación Alcorcón
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Getafe、Madrid、スペイン
- Hospital U. de Getafe
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Navarra
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Pamplona、Navarra、スペイン
- Hospital Virgen del Camino
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Sevilla
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Seville、Sevilla、スペイン、41013
- Hospital Virgen del Rocío
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Vizcaya
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Galdacano、Vizcaya、スペイン
- Hospital Galdakao-Usansolo
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Pulmonary hypertension
時間枠:2 years
|
Diagnosis on pulmonary hypertension after pulmonary thromboembolism
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2 years
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協力者と研究者
捜査官
- スタディチェア:Remedios Otero Candelera、Hospital Universitario Virgen del Rocío IBIS
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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