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NCT Number: NCT06000540

Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location contact

Keyur Vora, MD MS

SUB_INVESTIGATOR

Rohan Dharmakumar, PhD

CONTACT

[email protected]

317-274-0992

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥ 45 years of age
  • No known cardiac disease

Exclusion criteria

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

Treatment and study plan

RespirAct

Device

RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol

Primary outcomes

  1. Physiological Parameters Monitoring

    Time frame: 3 hours

    • Saturation of peripheral oxygen as percentage
    • Heart rate as beats per minute
    • Noninvasive blood pressure as mmHg
    • Partial pressure of oxygen as mmHg
    • Partial pressure of carbon dioxide as mmHg

  2. Assessment of Symptom Severity and Incidence

    Time frame: 3 hours

    • Chest pain
    • Headache
    • Dizziness
    • Confusion
    • Fatigue
    • Upset stomach
    • Nausea
    • Vomiting

Secondary outcomes

  1. Participant Completion

    Time frame: Day 1 and Day 2

    Procedure tolerability will be evaluated by the number of participants completing day 1 and day 2 of study participation.

  2. Patient comfort level score

    Time frame: 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.

  3. Quality of Cardiac MRI

    Time frame: 3 hours

    The cardiac MRI images will be assessed for quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Coordinator

CONTACT

[email protected]

317 274 0975

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Acronym: NIMO-Healthy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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