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

NCT06253884 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 12319
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Ratio of Maximum Signal Intensity (MSI) by BOLD MRI

  Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by blood oxygen level dependent (BOLD) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.

  3 hours

• Ratio of Maximum Signal Intensity (MSI) by FFP MRI

  Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by first pass perfusion (FFP) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.

  3 hours

Study Arms (1)

Coronary Artery Disease (CAD) Subjects

EXPERIMENTAL

Subjects with a of coronary artery disease will undergo computer-controlled gas challenges.

Device: RespirAct

Interventions

RespirAct DEVICE

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

Coronary Artery Disease (CAD) Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded)
• Hypotension (systolic blood pressure \< 100 mmHg)
• Significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.)
• Inability to schedule the research study within 30 days of the SPECT/PET study and prior to any coronary revascularization procedure
• Inability to voluntarily increase their breathing rate if prompted to do so
• 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)
• Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
• Persons with a history of significant heart, lung, kidney, or liver disease
• Persons with asthma
• Persons who have abnormal cardiac rhythm and rate
• Persons unable to tolerate MRI secondary to an inability to lie supine for 60-90 minutes or severe claustrophobia
• Persons whose renal function test does not meet MRI contrast protocol requirements \[estimated Glomerular filtration rate (eGFR) \< 40 mL/min/1.73m2\]
• Persons with a known history of allergy to gadolinium-based contrast
• Enrollment in another research study.
• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Chandana Saha, PhD

CONTACT

317 274 0975; csaha@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Krannert Cardiovascular Research Center

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: January 10, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)