Coronary Artery DiseaseNIMO-CADNCT06253884
Utilizing Carbon Dioxide for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease
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 technical feasibility of utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2027to 15 Dec 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults > 18 years of age
- Clinically stable individuals with suspected or known coronary artery disease (CAD)
- The SPECT/PET study indicates at least a mild to moderate myocardial ischemia (>5-9%) or fractional-flow-reserve (FFR) of <0.75.
Who cannot join
- Prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded)
- Hypotension (systolic blood pressure < 100 mmHg)
- Significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.)
- Inability to schedule the research study within 30 days of the SPECT/PET study and prior to any coronary revascularization procedure
- Inability to voluntarily increase their breathing rate if prompted to do so
- Persons with mechanically, magnetically, or electrically activated implants (such as cardiac pacemakers, neurostimulators, and infusion pumps), with ferromagnetic implants or foreign bodies (such as intracranial, aneurysm clips, shrapnel, and intraocular metal chips)
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- Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
- Persons with a history of significant heart, lung, kidney, or liver disease
- Persons with asthma
- Persons who have abnormal cardiac rhythm and rate
- Persons unable to tolerate MRI secondary to an inability to lie supine for 60-90 minutes or severe claustrophobia
- Persons whose renal function test does not meet MRI contrast protocol requirements [estimated Glomerular filtration rate (eGFR) < 40 mL/min/1.73m2]
- Persons with a known history of allergy to gadolinium-based contrast
- Enrollment in another research study.
- 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 Technical Feasibility of Utilizing Carbon Dioxide (CO2) for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease
This is a prospective pilot study to evaluate the safety, tolerability and technical feasibility of utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease.
Read the detailed description
The purpose of this study is to noninvasively assess changes in the heart's blood flow through inducing changes in the amount of carbon dioxide in the participant's blood and having them breathe various combinations of carbon dioxide and oxygen.
- 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 |
|---|---|---|
| Coronary Artery Disease (CAD) Subjects | Experimental | Subjects with a 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.
Ratio of Maximum Signal Intensity (MSI) by BOLD MRI
Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by blood oxygen level dependent (BOLD) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.
Measured: 3 hours
Ratio of Maximum Signal Intensity (MSI) by FFP MRI
Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by first pass perfusion (FFP) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.
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 posted12 Feb 2024
- Study start10 Jan 2027 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06253884
- Sponsor's protocol ID
- 12319
- Acronym
- NIMO-CAD
- Status last verified
- May 2026
- First submitted
- 2 Feb 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 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 Technical Feasibility of Utilizing Carbon Dioxide (CO2) for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06253884
- Acronym / sponsor ID
- NIMO-CAD / 12319
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 Jan 2027 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 12 Feb 2024 (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 technical feasibility of utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease.
Detailed description
The purpose of this study is to noninvasively assess changes in the heart's blood flow through inducing changes in the amount of carbon dioxide in the participant's blood and having them breathe various combinations of carbon dioxide and oxygen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) Subjects | Experimental | Device: RespirActSubjects with a of coronary artery disease will undergo computer-controlled gas challenges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults > 18 years of age
- Clinically stable individuals with suspected or known coronary artery disease (CAD)
- The SPECT/PET study indicates at least a mild to moderate myocardial ischemia (>5-9%) or fractional-flow-reserve (FFR) of <0.75.
Key exclusion criteria (15 listed)
- Prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded)
- Hypotension (systolic blood pressure < 100 mmHg)
- Significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.)
- Inability to schedule the research study within 30 days of the SPECT/PET study and prior to any coronary revascularization procedure
- Inability to voluntarily increase their breathing rate if prompted to do so
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 | Coronary Artery Disease (CAD) Subjects |
Primary outcome
Ratio of Maximum Signal Intensity (MSI) by BOLD MRI
Time frame: 3 hours
Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by blood oxygen level dependent (BOLD) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.
Ratio of Maximum Signal Intensity (MSI) by FFP MRI
Time frame: 3 hours
Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by first pass perfusion (FFP) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.
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 May 2026.
- 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 3 inclusion and 15 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 May 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 Chandana Saha, PhD (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?
Ratio of Maximum Signal Intensity (MSI) by BOLD MRI (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?
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 May 2026.