Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects (NIMO-Healthy)

Indiana University

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Device: RespirAct

Study type: Interventional

Funder types: Other

Identifiers

NCT06000540

15803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Hypercapnia Group A

Experimental group

Description:

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

Treatment:

Device: RespirAct

Hypercapnia Group B

Experimental group

Description:

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

Treatment:

Device: RespirAct

Hypercapnia Group C

Experimental group

Description:

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

Treatment:

Device: RespirAct

Hypoxia Group

Experimental group

Description:

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

Treatment:

Device: RespirAct