RespirAct Gas Challenge for Heart Disease Detection

(NIMO-Healthy Trial)

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Low blood pressure, Neurological, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect heart disease using a computer-controlled gas challenge called RespirAct. The researchers aim to determine if this method is safe, easy to tolerate, and effective in identifying coronary artery disease in healthy individuals. Participants will be divided into groups, each experiencing different gas conditions, to thoroughly test the method. The trial seeks adults aged 45 or older who have no known heart disease and can comfortably increase their breathing rate when asked. As an unphased study, this trial offers participants the chance to contribute to innovative research that could enhance heart disease detection methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for detecting heart disease?

Research shows that the RespirAct gas challenge is generally safe. This procedure uses a special machine to control the air participants breathe. Studies have found that similar breathing tests are safe for most people. In the RespirAct challenge, changes in oxygen and carbon dioxide levels in the blood are small and usually well-tolerated, with typically no serious side effects.

Participants in past studies did not report major issues. The tests are non-invasive, meaning nothing enters the body. Participants simply breathe in different gases. While every medical test carries some risk, evidence suggests that these gas challenges are usually safe and easy to manage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RespirAct gas challenge because it offers a fresh approach to detecting heart disease. Unlike traditional diagnostic methods that rely on imaging or invasive procedures, this technique uses computer-controlled gas challenges to evaluate cardiovascular health. This non-invasive method could potentially make heart disease detection quicker and less uncomfortable for patients. Additionally, by focusing on physiological responses to controlled gas mixtures, it might provide new insights into heart function that current tests can't capture.

What evidence suggests that the RespirAct gas challenge is effective for detecting heart disease?

This trial will evaluate the RespirAct gas challenge as a tool for detecting heart disease. Participants will join different groups, such as the Hypoxia Group or one of the Hypercapnia Groups (A, B, or C), to undergo computer-controlled gas challenges. Studies have shown that the RespirAct gas challenge can effectively detect heart disease. It uses a computer-controlled system to alter the gases participants breathe, testing how their blood vessels react. This non-invasive method, which doesn't require surgery or needles, focuses on analyzing breath. Research indicates that the brain and blood vessels' responses to changes in oxygen and carbon dioxide strongly indicate blood vessel health. Unlike traditional methods, which often involve more invasive techniques, this approach aims to spot coronary artery disease early by examining these blood vessel reactions. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This clinical trial is open to adults aged 45 and older who have no known heart disease. Participants must be able to increase their breathing rate when asked, not be pregnant or nursing, don't have an IUD, can lie on their back for up to 40 minutes, and don't suffer from serious neurological, lung, kidney or liver diseases.

Inclusion Criteria

I do not have any heart diseases.

I am 45 years old or older.

Exclusion Criteria

My blood pressure is usually below 100/60.

You can't speed up your breathing when asked to do so.

I cannot lie on my back for 30-40 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo computer-controlled gas challenges to evaluate safety, tolerability, and efficacy

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• RespirAct

Trial Overview The study is testing the safety and effectiveness of a needle-free method called RespirAct. It involves controlled breathing challenges using computer precision to detect coronary artery disease in healthy individuals.

How Is the Trial Designed?

Group I: Hypoxia Group Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Group II: Hypercapnia Group C Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Group III: Hypercapnia Group B Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Group IV: Hypercapnia Group A Experimental Treatment 1 Intervention

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Rohan Dharmakumar

Lead Sponsor

Trials

10

Recruited

120,000+

Citations

1. withpower.com withpower.com/trial/phase-coronary-artery-disease-9-2023-52e22

RespirAct Gas Challenge for Heart Disease Detection · Info ... The RespirAct Gas Challenge is unique because it uses exhaled breath analysis, a non-invasive method, to detect heart disease, unlike traditional methods that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4901170/

Respiratory challenge MRI: Practical aspects - PMC Patients with significant pulmonary or cardiac disease may need to be excluded from studies due to difficulties tolerating abnormal gas concentrations, issues ...

3. thornhillmedical.com thornhillmedical.com/may-30-2019-thornhill-medical-technology-investigative-tool-respiract-gas-control-system-contributes-to-international-team-led-by-scientists-from-lawson-health-research-institute-and-ceda/

Thornhill Medical Technology, Investigative Tool RespirAct ... To diagnose the potentially life-threatening condition, doctors typically inject a patient with radioactive dye that shows up on an MRI and take ...

4. dl.acm.org dl.acm.org/doi/10.1007/978-3-031-66538-7_4

Diagnostic Modeling to Identify Unrecognized Inpatient ... This work suggests that routinely available health record data can stratify the likelihood of hypercapnic respiratory failure among hospitalized adults.

5. nature.com nature.com/articles/s41598-021-99922-5

Ventilatory responses during and following hypercapnic ... Ventilatory responses during and following hypercapnic gas challenge are impaired in male but not female endothelial NOS knock-out mice.

6. thornhillmedical.com thornhillmedical.com/next-tech/respiract/

RespirAct RespirAct is a computer-controlled gas blender used to provide accurate, repeatable, non-invasive control of blood gases to stimulate vascular reactivity.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06000540

Study Details | NCT06000540 | Needle Free Assessment of ... This is a prospective pilot study to evaluate the safety, tolerability and efficacy of utilizing precise computer controlled gas challenge in healthy subjects ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213158216300791

Respiratory challenge MRI: Practical aspects Respiratory challenge MRI is the modification of arterial oxygen (PaO2) and/or carbon dioxide (PaCO2) concentration to induce a change in cerebral function ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11936916/

Variable cerebral blood flow responsiveness to acute ... At the (generally safe) levels of oxygen delivery used in mild-to-moderate hypoxia challenges, the blood flow response is comparatively small, limiting its ...