Coronary Artery Disease
Conditions
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.
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.
Interventions
DEVICERespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Maximum Signal Intensity (MSI) by BOLD MRI | 3 hours | 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. |
| Ratio of Maximum Signal Intensity (MSI) by FFP MRI | 3 hours | 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. |
Countries
United States
Contacts
CONTACTChandana Saha, PhD
Outcome results
None listed