Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

NCT ID: NCT06000540

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-10

Study Completion Date

2027-06-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hypercapnia Group A

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

Group Type EXPERIMENTAL

RespirAct

Intervention Type DEVICE

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

Hypercapnia Group B

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

Group Type EXPERIMENTAL

RespirAct

Intervention Type DEVICE

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

Hypercapnia Group C

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

Group Type EXPERIMENTAL

RespirAct

Intervention Type DEVICE

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

Hypoxia Group

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

Group Type EXPERIMENTAL

RespirAct

Intervention Type DEVICE

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

Interventions

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RespirAct

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Rohan Dharmakumar

Executive Director, Krannert Cardiovascular Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Central Contacts

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Clinical Research Coordinator

Role: CONTACT

317 274 0975

Facility Contacts

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Rohan Dharmakumar, PhD

Role: primary

317-274-0992

References

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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.

Reference Type RESULT
PMID: 32096705 (View on PubMed)

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.

Reference Type RESULT
PMID: 34687064 (View on PubMed)

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.

Reference Type RESULT
PMID: 23204541 (View on PubMed)

Other Identifiers

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15803

Identifier Type: -

Identifier Source: org_study_id

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