Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- FDG uptake in lung parenchyma
研究概览
简要总结
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently, pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been adequately characterized due to the lack of markers. A better understanding of the mechanisms that regulate this proliferative disorder will allow the identification of new therapeutic targets for HP.
The objective of the project is to identify cell proliferative processes in severe forms of PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs) analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs and the right ventricle between patients and controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with PAH:
- •Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
- •Exclusion of group 2,3,4 or 5
- •Patients with CTEPH:
- •Hemodynamic diagnosis of precapillary pulmonary hypertension: PAPm ≥25 mmHg, PCWP ≤15 mmHg
- •Persistence of thrombotic perfusion defects on pulmonary scintigraphy or angioCT, after 3 months or more of correct anticoagulant therapy
- •Healthy subjects
- •No known disease or condition
- •Normal lung function, chest x-ray, EKG and blood chemistry and haematology
排除标准
- •Severe comorbidity.
- •Pulmonary, pleural or rib cage disease interfering with FDG-PET acquisition
- •Malignancy with exception of basocellular carcinoma
- •Current smoker or former smoker (last 10 years or more than 10-year-pack).
- •Pregnant or lactating women Hyperglycemia (fasting above 200 mg/dL)
- •Hypersensitivity to the product or its excipients
研究组 & 干预措施
FDG
all patients will undergo a PET scan and will receive 18F fludeoxyglucose
干预措施: fludeoxyglucose (Drug)
结局指标
主要结局
FDG uptake in lung parenchyma
时间窗: 1 hour
次要结局
未报告次要终点
研究者
Joan Albert Barbera Mir
Dr
Hospital Clinic of Barcelona