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).
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Alava、西班牙
- Hospital de Araba
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Barcelona、西班牙
- Hospital del Mar
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Gerona、西班牙
- Hospital U. de Girona Doctor Josep Trueta
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Granada、西班牙
- Hospital U. Virgen de las Nieves
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Madrid、西班牙
- Hospital U. La Paz
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Madrid、西班牙
- Hospital U. Ramon y Cajal
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Sevilla、西班牙
- Hospital San Juan de Dios
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Valladolid、西班牙
- Hospital C. U. de Valladolid
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Zaragoza、西班牙
- Hospital C. U. Lozano Blesa
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Asturias
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Oviedo、Asturias、西班牙
- Hospital U. Central. de Asturias
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Barcelona
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Badalona、Barcelona、西班牙
- Hospital M. de Badalona
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Badalona、Barcelona、西班牙
- Hospital U. German Trias i Pujol
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Sant Cugat del Valles、Barcelona、西班牙
- Hospital G. de Cataluña
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Viladecans、Barcelona、西班牙
- Hospital de Viladecans
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Cantabria
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Santander、Cantabria、西班牙
- Hospital U. Marques de Valdecilla
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Torrelavega、Cantabria、西班牙
- Hospital Sierrallana
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Guipuzcua
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Bilbao、Guipuzcua、西班牙
- Hospital de Cruces
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La Rioja
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Logrono、La Rioja、西班牙
- Hospital San Pedro
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Madrid
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Alcorcón、Madrid、西班牙
- Hospital U. Fundación Alcorcón
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Getafe、Madrid、西班牙
- Hospital U. de Getafe
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Navarra
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Pamplona、Navarra、西班牙
- Hospital Virgen del Camino
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Sevilla
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Seville、Sevilla、西班牙、41013
- Hospital Virgen del Rocío
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Vizcaya
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Galdacano、Vizcaya、西班牙
- Hospital Galdakao-Usansolo
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pulmonary hypertension
大体时间：2 years
|
Diagnosis on pulmonary hypertension after pulmonary thromboembolism
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2 years
|
合作者和调查者
调查人员
- 学习椅：Remedios Otero Candelera、Hospital Universitario Virgen del Rocío IBIS
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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