Does Patent Foramen Ovale Size Matter in Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- level of interferon alpha 2
研究概览
简要总结
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have a higher core body temperature, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema (Lovering, Elliott & Davis J Appl Physiol 2016). Specific to this application,subjects with a PFO may have worse pulmonary gas exchange efficiency because a PFO is a potential source of right-to-left shunt that will make pulmonary gas exchange efficiency worse. If true, then this may negatively impact exercise capacity and/or exercise tolerance. Further, in those with a PFO compared to those without, preliminary work from the investigator's lab indicates that there may be an effect of PFO size on pulmonary gas exchange efficiency. This is such that those with a large PFO (grade 3 or higher) display significantly worse gas exchange efficiency compared to those with a small (grade 2 or lower) or no PFO,even at low exercise workloads. Additionally, the investigators were curious as to whether there would be a sex effect, but due to logistical constraints, the investigators were unable to recruit an equal number of female and male subjects. Thus, in addition to the potential size effect on the investigators outcome measures, the investigators would like to build on this work by examining the potential effect of biological sex. Although a PFO has been traditionally considered to have a minimal impact of physiology and pathophysiology, emerging evidence suggests this may not be the case. The investigator's lab is focused on understanding how and why a relatively small hole in the heart (PFO) can have a relatively large impact on cardiopulmonary and respiratory physiology, and how these impacts may be based on the size of the PFO.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-40
- •Known to have/not have a PFO.
排除标准
- •Previous history of coronary artery disease(ischemic heart disease such as angina, heart attack, myocardial infarction).
- •Failure of Modified Allen's Test in both hands.
- •Currently taking medications or herbal supplements for any heart or respiratory disease that they cannot stop taking for 48 hrsprior to testing (seasonal allergy medication not included in exclusion medications).
- •Lidocaine, nitroglycerine or heparin allergy.
- •Women who are pregnant or trying to become pregnant.
- •Previous history of any condition that would prevent the subject from performing cycle ergometer exercise (for exercise study only).
结局指标
主要结局
level of interferon alpha 2
时间窗: Baseline
inflammatory marker
level of interleukin 6
时间窗: Baseline
inflammatory marker
level of interleukin 33
时间窗: Baseline
inflammatory marker
level of myloperoxidase
时间窗: Baseline
inflammatory marker
core body temperature
时间窗: Baseline
subject's core body temperature as measured through an ingestible pill
level of Cystatin C
时间窗: Baseline
inflammatory marker
minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)
时间窗: Baseline
minute flow through intrapulmonary arteriovenous anastamoses
level of interleukin 10
时间窗: Baseline
inflammatory marker
level of myeloid-related protein 8/14
时间窗: Baseline
inflammatory marker
level of neutrophil gelatinase-associated lipocalin
时间窗: Baseline and 3 months post percutaneous closure
inflammatory marker
level of vascular cell adhesion protein 1
时间窗: Baseline
inflammatory marker
level of C-C motif cytokine 2
时间窗: Baseline
inflammatory marker
aerobic exercise capacity
时间窗: Baseline
ability to utilize oxygen while exercising, AKA Vo2MAX
alveolar-arterial difference in oxygen
时间窗: Baseline
difference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)
level of tumor necrosis factor alpha
时间窗: Baseline
inflammatory marker
level of interleukin 1 beta
时间窗: Baseline
inflammatory marker
matrix metallopeptidase 2
时间窗: Baseline and 3 months post percutaneous closure
inflammatory marker
level of osteopontin
时间窗: Baseline
inflammatory marker
six-minute walk test
时间窗: Baseline
distance covered in 6 minutes of walking
level of interleukin 23
时间窗: Baseline
inflammatory marker
level of myoglobin
时间窗: Baseline
inflammatory marker
level of Serum amyloid A
时间窗: Baseline
inflammatory marker
level of intracellular adhesion molecule 1
时间窗: Baseline
inflammatory marker
level of metallopeptidase 9
时间窗: Baseline
inflammatory marker
level of insulin like growth factor binding protein 4
时间窗: Baseline
inflammatory marker
level of interferon gamma
时间窗: Baseline
inflammatory marker
level of interleukin 8
时间窗: Baseline
inflammatory marker
level of interleukin 12p70
时间窗: Baseline
inflammatory marker
level of interleukin 17 alpha
时间窗: Baseline
inflammatory marker
level of interleukin 18
时间窗: Baseline
inflammatory marker
level of c-reactive protein
时间窗: Baseline
inflammatory marker
次要结局
未报告次要终点