Utilizing Carbon Dioxide for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease
NCT ID: NCT06253884
Last Updated: 2025-08-22
Study Results
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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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-10
2027-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
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.
RespirAct
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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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Rohan Dharmakumar
Executive Director, Krannert Cardiovascular Research Center
Locations
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IU Health Methodist Hospital
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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12319
Identifier Type: -
Identifier Source: org_study_id
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