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
Indiana University
Summary
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.
Description
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.
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Adults ≥ 45 years of age 2. No known cardiac disease Exclusion Criteria: 1. Low blood pressure (systolic blood pressure \< 100 mmHg) 2. Inability to voluntarily increase their breathing rate if prompted to do so 3. Persons with the inability to lie supine for 30-40 minutes 4. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's) 5. Persons with significant neurological, pulmonary, renal or hepatic disease 6. Persons who have an abnormal cardiac rhythm or resting heart rate \>100/min 7. Inability or unwillingness to provide informed consent
Interventions
- DeviceRespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Location
- IU Health Methodist HospitalIndianapolis, Indiana