Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06000540
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Hypercapnia Group A
    Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
  • Experimental: Hypercapnia Group B
    Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
  • Experimental: Hypercapnia Group C
    Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
  • Experimental: Hypoxia Group
    Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Primary Outcome Measure

Physiological Parameters Monitoring [ Time Frame: 3 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
IU Health Methodist HospitalIndianapolisIndiana46202
Rohan Dharmakumar, PhD
317-274-0992
Keyur Vora, MD MS (SUB_INVESTIGATOR)

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