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Could CO2 replace dye for heart scans? new study investigates

NCT ID NCT06253884

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study will test whether breathing controlled amounts of carbon dioxide (CO2) can help doctors see blood flow in the heart using MRI, without needing standard contrast dyes. Thirty adults with known or suspected coronary artery disease will take part. The goal is to check if the method is safe, tolerable, and technically feasible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carbon dioxide (CO2) gas delivered via RespirAct device
What this could lead to
If successful, this could lead to a safer, contrast-free way to diagnose blocked arteries in the heart using just CO2 and MRI.
What could go wrong
This is a very early pilot study with only 30 people, so it may not work as hoped or be widely usable. The approach is still experimental and needs much more testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults \> 18 years of age 2. Clinically stable individuals with suspected or known coronary artery disease (CAD) 3. The SPECT/PET study indicates at least a mild to moderate myocardial ischemia (\>5-9%) or fractional-flow-reserve (FFR) of \<0.75. Exclusion Criteria: 1. Prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded) 2. Hypotension (systolic blood pressure \< 100 mmHg) 3. Significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.) 4. Inability to schedule the research study within 30 days of the SPECT/PET study and prior to any coronary revascularization procedure 5. Inability to voluntarily increase their breathing rate if prompted to do so 6. 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) 7. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's) 8. Persons with a history of significant heart, lung, kidney, or liver disease 9. Persons with asthma 10. Persons who have abnormal cardiac rhythm and rate 11. Persons unable to tolerate MRI secondary to an inability to lie supine for 60-90 minutes or severe claustrophobia 12. Persons whose renal function test does not meet MRI contrast protocol requirements \[estimated Glomerular filtration rate (eGFR) \< 40 mL/min/1.73m2\] 13. Persons with a known history of allergy to gadolinium-based contrast 14. Enrollment in another research study. 15. Inability or unwillingness to provide informed consent

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.