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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Indiana University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Assessment of Symptom Severity and Incidence
- Status
- Not Yet Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Rohan Dharmakumar
Executive Director, Krannert Cardiovascular Research Center
Indiana University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Adults ≥ 45 years of age
- •No known cardiac disease
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Assessment of Symptom Severity and Incidence
Time Frame: 3 hours
1. Chest pain 2. Headache 3. Dizziness 4. Confusion 5. Fatigue 6. Upset stomach 7. Nausea 8. Vomiting
Physiological Parameters Monitoring
Time Frame: 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
Secondary Outcomes
- Participant Completion(Day 1 and Day 2)
- Patient comfort level score(3 hours)
- Quality of Cardiac MRI(3 hours)