Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: RespirAct

• Registration Number: NCT06000540
• Lead Sponsor: Indiana University

Brief Summary

This is a prospective pilot study to evaluate the safety, tolerability and efficacy of utilizing precise computer controlled gas challenge in healthy subjects for identification of coronary artery disease.

Detailed Description

This study will establish the safe and tolerable level of high PC02 and low P02 for future studies as potential stressors for coronary artery disease assessment.

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Study Start: 2025-07-01
• Primary Completion: 2026-06-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Adults ≥ 45 years of age
2. No known cardiac disease

Exclusion Criteria

1. Low blood pressure (systolic blood pressure < 100 mmHg)
2. Inability to voluntarily increase their breathing rate if prompted to do so
3. Persons with the inability to lie supine for 30-40 minutes
4. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
5. Persons with significant neurological, pulmonary, renal or hepatic disease
6. Persons who have an abnormal cardiac rhythm or resting heart rate >100/min
7. Inability or unwillingness to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypercapnia Group B	RespirAct	Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Hypercapnia Group C	RespirAct	Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Hypoxia Group	RespirAct	Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Hypercapnia Group A	RespirAct	Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Primary Outcome Measures

Name	Time	Method
Assessment of Symptom Severity and Incidence	3 hours	1. Chest pain; 2. Headache; 3. Dizziness; 4. Confusion; 5. Fatigue; 6. Upset stomach; 7. Nausea; 8. Vomiting
Physiological Parameters Monitoring	3 hours	1. Saturation of peripheral oxygen as percentage; 2. Heart rate as beats per minute; 3. Noninvasive blood pressure as mmHg; 4. Partial pressure of oxygen as mmHg; 5. Partial pressure of carbon dioxide as mmHg

Secondary Outcome Measures

Name	Time	Method
Participant Completion	Day 1 and Day 2	Procedure tolerability will be evaluated by the number of participants completing day 1 and day 2 of study participation.
Patient comfort level score	3 hours	Participants will be asked to rate their comfort level for breathing from the mask and the gas changes as Painful, Not Comfortable, Tolerable for short time, tolerable for entire study, or comfortable.
Quality of Cardiac MRI	3 hours	The cardiac MRI images will be assessed for quality.

Trial Locations

Locations (1)

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States