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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Invasive Cardiac Catheterization (ICA); Procedure: Coronary Computed Tomographic Angiogram (CCTA); Procedure: Dynamic Cardiac Positron Emission Tomography (dPET)

• Registration Number: NCT04221594
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAD detection/risk assessment	Coronary Computed Tomographic Angiogram (CCTA)	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.
CAD detection/risk assessment	Invasive Cardiac Catheterization (ICA)	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.
CAD detection/risk assessment	Dynamic Cardiac Positron Emission Tomography (dPET)	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.

Primary Outcome Measures

Name	Time	Method
Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches	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	Up to 3 months	Ratio of absolute hyperemic MBFs (abnormal / normal) measured in mL/min/g.

Secondary Outcome Measures

Name	Time	Method
Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio	Up to 3 months	Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio will be calculated
Distal/proximal pressure ratio	Up to 3 months	Distal/proximal pressure ratio will be calculated
Absolute myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches	Up to 3 months	Absolute myocardial blood flow (MBF) measured in ml/min/gm provides incremental diagnostic and prognostic information over relative perfusion alone.
Myocardial flow reserve (MFR) measurement comparing non-invasive to the traditional approaches	Up to 3 months	Myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone.
Fractional Flow Reserve (FFR) measurement comparing non-invasive to the traditional approaches	Up to 3 months	FFR calculates the maximum flow down a vessel in the presence of stenosis compared to maximum flow in the hypothetical absence of the stenosis.
Discriminatory power of dPET/CTA. And FFR(CTA)	Up to 3 months	Predictive discriminatory power of each technique will be compared to ICA (FFR)

Trial Locations

Locations (6)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Saint Francis Hospital & Heart Center; 🇺🇸 Roslyn, New York, United States

Chonnam National University; 🇰🇷 Gwangju, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of