Utilizing Carbon Dioxide for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease (NIMO-CAD)

A Prospective Pilot Study to Evaluate the Safety, Tolerability and Technical Feasibility of Utilizing Carbon Dioxide (CO2) for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: RespirAct

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chandana Saha, PhD; Phone Number: 317 274 0975; Email: csaha@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital
      • Contact: Rohan Dharmakumar, PhD; Phone Number: 317-274-0992; Email: rdkumar@iu.edu
      • Sub-Investigator: Keyur Vora, MD MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coronary Artery Disease (CAD) Subjects; Subjects with a of coronary artery disease will undergo computer-controlled gas challenges.	Device: RespirAct; RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 12319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No