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

Coronary Artery Disease Clinical Trial

— NIMO-CAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253884
• Other study ID #: 12319
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: Chandana Saha, PhD
• Phone: 317 274 0975
• Email: csaha[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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