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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Physiological Parameters Monitoring
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
Time frame: 3 hours
Assessment of Symptom Severity and Incidence
1. Chest pain 2. Headache 3. Dizziness 4. Confusion 5. Fatigue 6. Upset stomach 7. Nausea 8. Vomiting
Time frame: 3 hours
Participant Completion
Procedure tolerability will be evaluated by the number of participants completing day 1 and day 2 of study participation.
Time frame: Day 1 and Day 2
Patient comfort level score
Participants will be asked to rate their comfort level for breathing from the mask and the gas changes as Painful, Not Comfortable, Tolerable for short time, tolerable for entire study, or comfortable.
Time frame: 3 hours
Quality of Cardiac MRI
The cardiac MRI images will be assessed for quality.
Time frame: 3 hours
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