Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery

Emory University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary Computed Tomographic Angiogram (CCTA); Procedure: Dynamic Cardiac Positron Emission Tomography (dPET); Procedure: Invasive Cardiac Catheterization (ICA)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04221594

IRB00107151

1R01HL143350-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

68 participants in 1 patient group

CAD detection/risk assessment

Description:

Patients with angina referred for the assessment of CAD will undergo imaging studies to develop tools to fuse coronary anatomic data obtained from CCTA with dPET data to non-invasively measure absolute MBF, MFR and RFR along vessels centerlines and across coronary lesions.

Treatment:

Procedure: Coronary Computed Tomographic Angiogram (CCTA)

Procedure: Dynamic Cardiac Positron Emission Tomography (dPET)

Procedure: Invasive Cardiac Catheterization (ICA)