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RespirAct Gas Challenge for Heart Disease Detection (NIMO-Healthy Trial)

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No known cardiac disease
Adults ≥ 45 years of age
Must not have
Low blood pressure (systolic blood pressure < 100 mmHg)
Persons with the inability to lie supine for 30-40 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 2
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a computer-controlled gas challenge is safe & effective for detecting heart disease in healthy people.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-invasive respiratory tests with RespirAct in healthy subjects without known cardiac issues, significant side effects are not anticipated. However, discomfort due to increased breathing rates may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any heart diseases.
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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is usually below 100/60.
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I cannot lie on my back for 30-40 minutes.
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My heart beats irregularly or faster than 100 beats per minute.
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I have a serious brain, lung, kidney, or liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Symptom Severity and Incidence
Physiological Parameters Monitoring
Secondary study objectives
Participant Completion
Patient comfort level score
Quality of Cardiac MRI

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Hypoxia GroupExperimental Treatment1 Intervention
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Group II: Hypercapnia Group CExperimental Treatment1 Intervention
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Group III: Hypercapnia Group BExperimental Treatment1 Intervention
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Group IV: Hypercapnia Group AExperimental Treatment1 Intervention
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,978 Total Patients Enrolled
9 Trials studying Coronary Artery Disease
938 Patients Enrolled for Coronary Artery Disease
Rohan DharmakumarLead Sponsor
8 Previous Clinical Trials
201,949 Total Patients Enrolled
~53 spots leftby Oct 2025
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