A Prospective Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Utilizing Precise Computer Controlled Gas Challenge in Healthy Subjects for Identification of Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Assessment of Symptom Severity and Incidence
研究概览
简要总结
This is a prospective pilot study to evaluate the safety, tolerability and efficacy of utilizing precise computer controlled gas challenge in healthy subjects for identification of coronary artery disease.
详细描述
This study will establish the safe and tolerable level of high PC02 and low P02 for future studies as potential stressors for coronary artery disease assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 45 years of age
- •No known cardiac disease
排除标准
- •Low blood pressure (systolic blood pressure < 100 mmHg)
- •Inability to voluntarily increase their breathing rate if prompted to do so
- •Persons with the inability to lie supine for 30-40 minutes
- •Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
- •Persons with significant neurological, pulmonary, renal or hepatic disease
- •Persons who have an abnormal cardiac rhythm or resting heart rate >100/min
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
Hypercapnia Group A
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
干预措施: RespirAct (Device)
Hypercapnia Group B
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
干预措施: RespirAct (Device)
Hypercapnia Group C
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
干预措施: RespirAct (Device)
Hypoxia Group
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
干预措施: RespirAct (Device)
结局指标
主要结局
Assessment of Symptom Severity and Incidence
时间窗: 3 hours
1. Chest pain 2. Headache 3. Dizziness 4. Confusion 5. Fatigue 6. Upset stomach 7. Nausea 8. Vomiting
Physiological Parameters Monitoring
时间窗: 3 hours
1. Saturation of peripheral oxygen as percentage 2. Heart rate as beats per minute 3. Noninvasive blood pressure as mmHg 4. Partial pressure of oxygen as mmHg 5. Partial pressure of carbon dioxide as mmHg
次要结局
- Participant Completion(Day 1 and Day 2)
- Patient comfort level score(3 hours)
- Quality of Cardiac MRI(3 hours)
研究者
Rohan Dharmakumar
Executive Director, Krannert Cardiovascular Research Center
Indiana University