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Lung and Heart Function Across Decades of Life in Health

2026年9月9日 更新者:University of California, San Francisco

Lung and Heart Function Across Decades of Life in Healthy Population

The main objective of this study is to develop baseline "normal" reference values of both lung and heart function for healthy adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations.

This study will involve performing key components of the Department of Veterans Affairs the Airborne Hazards and Open Burn Pit Center of Excellence (AHOBPCE) and a VA network of Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) Core Clinical Evaluation in asymptomatic unexposed healthy controls without known lung or heart disease to serve as a "normal" control comparator group for veterans evaluated by PDCEN.

研究概览

详细说明

This is an observational study to recruit and thoroughly characterize 200 age- and gender-matched healthy controls without a history of exposure to airborne hazards. The childhood health and disease profiles of participants will also be evaluated to provide assessment of their physical fitness as adolescents. The participants will undergo detailed clinical, physiological, and radiological evaluations that will match the PDCEN Core Clinical Evaluation, which includes administration of health, environmental and occupational exposures, respiratory, and physical fitness questionnaires, pulmonary function testing (PFT), forced oscillometry (FOT), cardiopulmonary exercise testing (CPET) with maximum effort, dynamic hyperinflation, and exercise-induced bronchospasm protocols, methacholine challenge testing, transthoracic echocardiography, and computer tomography (CT) of chest, as well as pulmonary and systemic biomarker analysis including fractional exhalation of nitric oxide (FeNO) and peripheral blood sampling for blood count and metabolic panel including liver and kidney function.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • California
      • San Francisco、California、美国、94143
        • 招聘中
        • University of California San Francisco
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Healthy "normal" adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations.

描述

Inclusion Criteria:

  • Age 24-68
  • U.S. Veteran deployed between 1990 to 2021
  • No respiratory complaints (defined as modified Medical Research Council score = 0)
  • No use of respiratory medications

Exclusion Criteria:

  • Non-English speaking
  • Pregnancy
  • BMI>35 Kg/m2
  • Tobacco smoking within prior year
  • Lifetime tobacco smoking of >5 pack-years
  • Current inhaled cannabis use (any modality) >2x weekly
  • Prior inhaled cannabis uses exceeding 2x weekly within the prior year
  • Illicit drug use (other than cannabis)
  • No prior or current major organ disease, including but not limited to:

    • Neuromuscular weakness
    • History of malignancy (other than non-melanoma skin cancer)-- HIV/AIDS
    • Autoimmune disease
    • Solid-organ or hematopoietic stem cell transplant
    • Cardiovascular disease (other than mild HTN; < 140/90; controlled on 2 or less medications)

      • Poorly-controlled HTN (SBP>140 or DBP>90 or use of more than 2 anti-hypertensive medications)
      • Any history of congestive heart failure (CHF, either HFpEF or HFrEF)
      • Any history of arrythmia (including atrial fibrillation)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
Pulmonary Function Testing: The purpose of this test is to determine the participant's lungs' capacity.
2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
Cardiopulmonary Exercise Testing: The purpose of this test is to determine the participant's lung and heart capacity during maximum exercise.
2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
Echocardiogram: The purpose of this test is to determine how well the subject's heart is functioning and identify causes of cardiac-related symptoms.
2 years

次要结果测量

结果测量
措施说明
大体时间
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
FeNO: The purpose of this test is to measure a marker of inflammation in the lungs.
2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
Forced Oscillation Technique: The purpose of this test is to determine the resistance of the airways in the subject's lungs.
2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
Methacholine Challenge Test: The purpose of this test is to determine how irritable the participant's airways are by administering gradually increasing doses of methacholine.
2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
Chest CT: The purpose of this test is to examine for abnormalities and to help diagnose the cause of signs or symptoms of chest disease.
2 years
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
大体时间:2 years
Peripheral Blood Draw: The purpose of this blood draw is to determine metabolic and blood inflammatory markers.
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mehrdad Arjomandi, MD、University of California, San Francisco

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年8月1日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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