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

April 24, 2024 updated by: Rohan Dharmakumar, Indiana University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chandana Saha, PhD
  • Phone Number: 317 274 0975
  • Email: csaha@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Methodist Hospital
        • Contact:
          • Rohan Dharmakumar, PhD
          • Phone Number: 317-274-0992
          • Email: rdkumar@iu.edu
        • Sub-Investigator:
          • Keyur Vora, MD MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypercapnia Group A
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Device: RespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Experimental: Hypercapnia Group B
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Device: RespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Experimental: Hypercapnia Group C
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Device: RespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Experimental: Hypoxia Group
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Device: RespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological Parameters Monitoring
Time Frame: 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
3 hours
Assessment of Symptom Severity and Incidence
Time Frame: 3 hours
  1. Chest pain
  2. Headache
  3. Dizziness
  4. Confusion
  5. Fatigue
  6. Upset stomach
  7. Nausea
  8. Vomiting
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 and Day 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 hours
Quality of Cardiac MRI
Time Frame: 3 hours
The cardiac MRI images will be assessed for quality.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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