Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery to Determine the Physiological Significance of Specific Coronary Lesions.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 68
- Locations
- 6
- Primary Endpoint
- Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
Study Overview
Brief Summary
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. Results will be compared to those obtained invasively in the catheterization laboratory.
Detailed Description
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. These results will be compared to those obtained invasively in the catheterization laboratory. The long-term objective of the study is to improve the care of cardiac patients by developing, validating and implementing clinically computer-based methods to noninvasively determine the physiological significance of specific coronary lesions using methods to fuse and quantify multi-modality cardiac imagery.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (≥18 years of age) - as the research topic to be studied is irrelevant to children
- •Written consent form
- •Patients with prior dynamic PET or CCTA or ICA for any indications
Exclusion Criteria
- •Previous history of allergy to iodinated contrast
- •Previous CABG
- •Serum creatinine levels >1.8 mg/dl unless patient has end stage kidney disease, not producing any urine and dialysis
- •History of claustrophobia (CT tunnel length of more than 100 cm)
- •Significant arrhythmias or tachycardia
- •History of frequent asthma attacks or acting wheezing
- •Second- and third-degree heart block
- •Systolic blood pressure of < 90 mmHg
- •Heart failure with NYHA class III-IV at the time of the CCTA procedure. If it is deemed that, the heart failure has been resolved or the patient was incorrectly labeled as having heart failure the radiology physician in charge will verify the absence of Heart Failure at the time of CCTA and perform the procedure.
- •Recent myocardial infarction
- •If the patient has been diagnosed with unstable angina within 24 hours prior to CCTA, the patient will not be consented. If the patient does not have the diagnosis of unstable angina and is consented, the radiology physician in charge will verify the absence of unstable angina at the time of CCTA.
- •Patients enrolled and consented for the invasive measurements that at the time of catheterization exhibit severe vessel disease and/or obstructions that prevent the operator from safely conducting the measurements will be removed from the study; further research imaging sessions - if planned - will be canceled and patients indicated as "screen failure" in our enrollment log.
Outcomes
Primary Outcomes
Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
Time Frame: Up to 3 months
Myocardial blood flow (MBF) measured in milliliters per minute per gram of tissue is providing unique pathophysiologic and diagnostic information on the function of the coronary macro- and microcirculation.
Vessel-specific quantification of myocardial blood flow RFR
Time Frame: Up to 3 months
Ratio of absolute hyperemic MBFs (abnormal / normal) measured in mL/min/g.
Secondary Outcomes
- Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio(Up to 3 months)
- Distal/proximal pressure ratio(Up to 3 months)
- Absolute myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches(Up to 3 months)
- Myocardial flow reserve (MFR) measurement comparing non-invasive to the traditional approaches(Up to 3 months)
- Fractional Flow Reserve (FFR) measurement comparing non-invasive to the traditional approaches(Up to 3 months)
- Discriminatory power of dPET/CTA. And FFR(CTA)(Up to 3 months)
Investigators
Marina Piccinelli
Principal Investigator
Emory University