Pilot Study for Perfusion Heterogeneity: a Mechanistic Image-Based Emphysema Phenotype
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration
研究概览
简要总结
The purpose of this study is to determine if the events leading to smoking-associated centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced inflammation.
详细描述
Overall goals of this study are to 1) determine the effects on sildenafil on the heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT 2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate normal and susceptible smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between the ages of 30 and
- •Must be currently smoking at least 1/2 pack/day (confirmed with cotinine level).
- •Must have pulmonary function test (PFT) results that meet the following:
- •Forced Expiratory Volume at one second (FEV1)/Forced Vital Capacity (FVC) > 70%
- •Forced Expiratory Flow at 25-75% (FEF25-75) > 79% of predicted
- •FVC greater than 80% of predicted
- •Must be able to give informed consent for self.
排除标准
- •Pregnant or breastfeeding females.
- •Body Mass Index (BMI) greater than
- •Weight of greater than 220 pounds (100 kg).
- •Allergies to shell fish, seafood, eggs or iodine.
- •Heart disease, kidney disease or diabetes.
- •Diagnosis of asthma.
- •Usage of any medications that are known to affect the heart or lungs (contraceptives, anti-depressants, analgesics EXCEPT aspirin, antihypertensives, and medications for osteoporosis and gastrointestinal diseases will be allowed).
- •Any metal in or on the body between the nose and the abdomen.
- •Any major organ system disease (by judgment of study medical team).
- •For the subjects that will receive Sildenafil as part of the study, additional exclusion criteria are as follows:
- •Nitroglycerin usage.
- •Prior history of hypersensitivity to Sildenafil.
研究组 & 干预措施
Nonsusceptible Smokers (NS)
8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
干预措施: Sildenafil study group (Drug)
Susceptible Smokers (SS)
11 subjects recruited to study non-contrast imaging at TLC and 20% VC and with contrast using DECT to assess pefused blood volume. For the intervention the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
干预措施: Sildenafil study group (Drug)
结局指标
主要结局
Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration
时间窗: Change of perfused blood volume from baseline at one hour after sildenafil administration.
Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil.
次要结局
未报告次要终点
研究者
Eric A. Hoffman
Professor
University of Iowa