Utilizing Carbon Dioxide for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease

NCT ID: NCT06253884

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-10

Study Completion Date

2027-07-15

Brief Summary

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This is a prospective pilot study to evaluate the safety, tolerability and technical feasibility of utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease.

Detailed Description

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The purpose of this study is to noninvasively assess changes in the heart's blood flow through inducing changes in the amount of carbon dioxide in the participant's blood and having them breathe various combinations of carbon dioxide and oxygen.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Coronary Artery Disease (CAD) Subjects

Subjects with a 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 \> 18 years of age
2. Clinically stable individuals with suspected or known coronary artery disease (CAD)
3. The SPECT/PET study indicates at least a mild to moderate myocardial ischemia (\>5-9%) or fractional-flow-reserve (FFR) of \<0.75.

Exclusion Criteria

1. Prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded)
2. Hypotension (systolic blood pressure \< 100 mmHg)
3. Significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.)
4. Inability to schedule the research study within 30 days of the SPECT/PET study and prior to any coronary revascularization procedure
5. Inability to voluntarily increase their breathing rate if prompted to do so
6. Persons with mechanically, magnetically, or electrically activated implants (such as cardiac pacemakers, neurostimulators, and infusion pumps), with ferromagnetic implants or foreign bodies (such as intracranial, aneurysm clips, shrapnel, and intraocular metal chips)
7. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
8. Persons with a history of significant heart, lung, kidney, or liver disease
9. Persons with asthma
10. Persons who have abnormal cardiac rhythm and rate
11. Persons unable to tolerate MRI secondary to an inability to lie supine for 60-90 minutes or severe claustrophobia
12. Persons whose renal function test does not meet MRI contrast protocol requirements \[estimated Glomerular filtration rate (eGFR) \< 40 mL/min/1.73m2\]
13. Persons with a known history of allergy to gadolinium-based contrast
14. Enrollment in another research study.
15. Inability or unwillingness to provide informed consent
Minimum Eligible Age

18 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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Chandana Saha, PhD

Role: CONTACT

317 274 0975

Facility Contacts

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Rohan Dharmakumar, PhD

Role: primary

317-274-0992

Other Identifiers

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12319

Identifier Type: -

Identifier Source: org_study_id

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