Coronary Artery Disease
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICERespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Sponsors
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological Parameters Monitoring | 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 |
| Assessment of Symptom Severity and Incidence | 3 hours | 1. Chest pain 2. Headache 3. Dizziness 4. Confusion 5. Fatigue 6. Upset stomach 7. Nausea 8. Vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Completion | Day 1 and Day 2 | Procedure tolerability will be evaluated by the number of participants completing day 1 and day 2 of study participation. |
| Patient comfort level score | 3 hours | 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. |
| Quality of Cardiac MRI | 3 hours | The cardiac MRI images will be assessed for quality. |
Countries
United States
Contacts
CONTACTClinical Research Coordinator
Outcome results
None listed