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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 2
Awards & highlights

NIMO-Healthy Trial 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.Check my eligibility
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.See study design
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.

NIMO-Healthy Trial Eligibility Criteria

Inclusion Criteria

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

NIMO-Healthy Trial 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

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

NIMO-Healthy 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.

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,081 Total Patients Enrolled
9 Trials studying Coronary Artery Disease
938 Patients Enrolled for Coronary Artery Disease
Rohan DharmakumarLead Sponsor
5 Previous Clinical Trials
200,612 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study accommodate participants aged sixty and above?

"This investigation seeks participants aged 45 and above, but under the age of 75."

Answered by AI

Am I eligible to take part in this investigation?

"The clinical trial will accept participants who have been diagnosed with coronary artery disease, aged 45 to 75 years. It is looking for 80 individuals in total."

Answered by AI

Are there still opportunities for individuals to enroll in this trial?

"The clinical trial mentioned is not currently recruiting patients. This information was initially posted on October 15th 2023 and last updated 8/31/2023, as cited by clinicaltrials.gov. Nonetheless, there are a plethora of other studies that remain open for enrollment at this moment in time."

Answered by AI
~53 spots leftby Dec 2024