Carbon Dioxide for Coronary Artery Disease

(NIMO-CAD Trial)

Overseen By Chandana Saha, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Myocardial infarction, Hypotension, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the treatment RespirAct differ from other treatments for coronary artery disease?

RespirAct is unique because it uses controlled carbon dioxide levels to influence coronary blood flow, potentially improving oxygen delivery to the heart, unlike traditional treatments that primarily focus on reducing cholesterol or blood pressure. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with coronary artery disease. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I am older than 18 years.

I have stable heart disease or it's suspected.

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

Hypotension (systolic blood pressure < 100 mmHg)

Inability to voluntarily increase their breathing rate if prompted to do so

I have had a heart attack in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo computer-controlled gas challenges to assess coronary blood flow using carbon dioxide

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RespirAct

Trial Overview The trial is testing RespirAct, a method using carbon dioxide to assess blood flow in the coronary arteries. It's a pilot study focusing on how safe and feasible this technique is for patients with heart issues.

Participant Groups

Group I: Coronary Artery Disease (CAD) Subjects Experimental Treatment 1 Intervention

Subjects with a 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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The response of canine coronary vascular resistance to local alterations in coronary arterial P CO2. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Synergistic action of myocardial oxygen and carbon dioxide in controlling coronary blood flow. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Carbon Dioxide and the Heart: Physiology and Clinical Implications. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of intermittent apnea on myocardial tissue oxygenation--a study using oxygenation-sensitive cardiovascular magnetic resonance. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Carbon dioxide field flooding techniques for open heart surgery: monitoring and minimizing potential adverse effects. [2017]