NCT06000540

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
13mo left

Started Jan 2026

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

August 3, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

August 3, 2023

Last Update Submit

August 20, 2025

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Physiological Parameters Monitoring

    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

    1. Chest pain 2. Headache 3. Dizziness 4. Confusion 5. Fatigue 6. Upset stomach 7. Nausea 8. Vomiting

    3 hours

Secondary Outcomes (3)

  • Participant Completion

    Day 1 and Day 2

  • Patient comfort level score

    3 hours

  • Quality of Cardiac MRI

    3 hours

Study Arms (4)

Hypercapnia Group A

EXPERIMENTAL

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

Device: RespirAct

Hypercapnia Group B

EXPERIMENTAL

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

Device: RespirAct

Hypercapnia Group C

EXPERIMENTAL

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

Device: RespirAct

Hypoxia Group

EXPERIMENTAL

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

Device: RespirAct

Interventions

RespirActDEVICE

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

Hypercapnia Group AHypercapnia Group BHypercapnia Group CHypoxia Group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

  • Yang HJ, Dey D, Sykes J, Butler J, Biernaski H, Kovacs M, Bi X, Sharif B, Cokic I, Tang R, Slomka P, Prato FS, Dharmakumar R. Heart Rate-Independent 3D Myocardial Blood Oxygen Level-Dependent MRI at 3.0 T with Simultaneous 13N-Ammonia PET Validation. Radiology. 2020 Apr;295(1):82-93. doi: 10.1148/radiol.2020191456. Epub 2020 Feb 25.

    PMID: 32096705RESULT

  • Poublanc J, Sobczyk O, Shafi R, Sayin ES, Schulman J, Duffin J, Uludag K, Wood JC, Vu C, Dharmakumar R, Fisher JA, Mikulis DJ. Perfusion MRI using endogenous deoxyhemoglobin as a contrast agent: Preliminary data. Magn Reson Med. 2021 Dec;86(6):3012-3021. doi: 10.1002/mrm.28974. Epub 2021 Oct 22.

    PMID: 34687064RESULT

  • Spano VR, Mandell DM, Poublanc J, Sam K, Battisti-Charbonney A, Pucci O, Han JS, Crawley AP, Fisher JA, Mikulis DJ. CO2 blood oxygen level-dependent MR mapping of cerebrovascular reserve in a clinical population: safety, tolerability, and technical feasibility. Radiology. 2013 Feb;266(2):592-8. doi: 10.1148/radiol.12112795. Epub 2012 Nov 30.

    PMID: 23204541RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Clinical Research Coordinator

CONTACT

317 274 0975csaha@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Krannert Cardiovascular Research Center

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 21, 2023

Study Start

January 10, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)