Coronary Artery DiseaseNIMO-HealthyNCT06000540
Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects
A study testing RespirAct in people with Coronary Artery Disease, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- RespirAct
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2027to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 45 years of age
- No known cardiac disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Rohan Dharmakumar, PhD, 317-274-0992, rdkumar@iu.edu
Keyur Vora, MD MS
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- RespirAct
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespirActDevice
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Hypercapnia Group A | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. Receives: Device: RespirAct |
| Hypercapnia Group B | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. Receives: Device: RespirAct |
| Hypercapnia Group C | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. Receives: Device: RespirAct |
| Hypoxia Group | Experimental | Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. Receives: Device: RespirAct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Parameters Monitoring
- Saturation of peripheral oxygen as percentage
- Heart rate as beats per minute
- Noninvasive blood pressure as mmHg
- Partial pressure of oxygen as mmHg
- Partial pressure of carbon dioxide as mmHg
Measured: 3 hours
Assessment of Symptom Severity and Incidence
- Chest pain
- Headache
- Dizziness
- Confusion
- Fatigue
- Upset stomach
- Nausea
- Vomiting
Measured: 3 hours
Secondary outcomes (3)
Participant Completion
Procedure tolerability will be evaluated by the number of participants completing day 1 and day 2 of study participation.
Measured: 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.
Measured: 3 hours
Quality of Cardiac MRI
The cardiac MRI images will be assessed for quality.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Nov 2027 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohan Dharmakumar, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000540
- Sponsor's protocol ID
- 15803
- Acronym
- NIMO-Healthy
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32096705Poublanc 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.
PubMed 34687064Spano 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.
PubMed 23204541
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06000540
- Acronym / sponsor ID
- NIMO-Healthy / 15803
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Nov 2027 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypercapnia Group A | Experimental | Device: RespirActHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
| Hypercapnia Group B | Experimental | Device: RespirActHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
| Hypercapnia Group C | Experimental | Device: RespirActHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
| Hypoxia Group | Experimental | Device: RespirActHealthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥ 45 years of age
- No known cardiac disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RespirActRespirAct device-based computer-controlled gas delivery at different concentrations as per protocol | Device | Hypercapnia Group A, Hypercapnia Group B, Hypercapnia Group C, Hypoxia Group |
Primary outcome
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
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
3 secondary outcomes
Participant Completion
Time frame: Day 1 and Day 2
Patient comfort level score
Time frame: 3 hours
Quality of Cardiac MRI
Time frame: 3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 32096705Yang 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.
- Results publication: PubMed 34687064Poublanc 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.
- Results publication: PubMed 23204541Spano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RespirAct in people with Coronary Artery Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (317 274 0975, csaha@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological Parameters Monitoring (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000540, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.