Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06000540
- Status
- Not Yet Recruiting
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Conditions
- Coronary Artery Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- RespirAct — DEVICERespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Study Details
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.
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- May 2026
- Primary completion
- Aug 30, 2027
- Completion
- Aug 30, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Hypercapnia Group AHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
- Experimental: Hypercapnia Group BHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
- Experimental: Hypercapnia Group CHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
- Experimental: Hypoxia GroupHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Primary Outcome Measure
Physiological Parameters Monitoring [ Time Frame: 3 hours ]
Central Contacts
- Clinical Research Coordinator317 274 0975
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | Keyur Vora, MD MS (SUB_INVESTIGATOR) |
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