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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypercapnia Group A | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
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| Hypercapnia Group B | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
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| Hypercapnia Group C | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
|
| Hypoxia Group | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RespirAct | Device | RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Parameters Monitoring |
| 3 hours |
| Assessment of Symptom Severity and Incidence |
| 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Completion | Procedure tolerability will be evaluated by the number of participants completing day 1 and day 2 of study participation. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | 317 274 0975 | csaha@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32096705 | Result | Yang HJ, Dey D, Sykes J, Butler J, Biernaski H, Kovacs M, Bi X, Sharif B, Cokic I, Tang R, Slomka P, Prato FS, Dharmakumar R. Heart Rate-Independent 3D Myocardial Blood Oxygen Level-Dependent MRI at 3.0 T with Simultaneous 13N-Ammonia PET Validation. Radiology. 2020 Apr;295(1):82-93. doi: 10.1148/radiol.2020191456. Epub 2020 Feb 25. | |
| 34687064 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 3 hours |
| Quality of Cardiac MRI | The cardiac MRI images will be assessed for quality. | 3 hours |
| Poublanc J, Sobczyk O, Shafi R, Sayin ES, Schulman J, Duffin J, Uludag K, Wood JC, Vu C, Dharmakumar R, Fisher JA, Mikulis DJ. Perfusion MRI using endogenous deoxyhemoglobin as a contrast agent: Preliminary data. Magn Reson Med. 2021 Dec;86(6):3012-3021. doi: 10.1002/mrm.28974. Epub 2021 Oct 22. |
| 23204541 | Result | Spano VR, Mandell DM, Poublanc J, Sam K, Battisti-Charbonney A, Pucci O, Han JS, Crawley AP, Fisher JA, Mikulis DJ. CO2 blood oxygen level-dependent MR mapping of cerebrovascular reserve in a clinical population: safety, tolerability, and technical feasibility. Radiology. 2013 Feb;266(2):592-8. doi: 10.1148/radiol.12112795. Epub 2012 Nov 30. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |