An observational study in Coronary Artery Disease, sponsored by Emory University. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Emory University · Observational
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 68 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
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Patients with angina referred to an initial imaging test for the assessment of CAD will be screened and considered for inclusion in the study. Different hospital policies and guidelines determine which initial test is commonly requested: at Emory University Hospital patients who underwent a dPET will be considered for enrollment; at the South Korean centers patients who received a CTA will be screened. Depending on test results, patients who are referred to undergo a cardiac catheterization, will be invited to participate in the study.
Exclusion Criteria:
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.
Procedure: Invasive Cardiac Catheterization (ICA) · Procedure: Coronary Computed Tomographic Angiogram (CCTA) · Procedure: Dynamic Cardiac Positron Emission Tomography (dPET)
Invasive functional measurements will be performed to assess the functional significance of specific lesions by means of FFR and CFR, and to test the presence of microvascular disease by means of IMR in all vessels for which the procedures are feasible. In summary, a 5- to 7-F guide catheter without side holes is used to engage the coronary artery and a pressure-temperature sensor-tipped guidewire introduced. The pressure sensor is positioned at the distal segment of a target vessel, and intracoronary nitroglycerine (100-200 mg) administered before each measurement. The best systolic and diastolic phase (located between 30-50%, and 60-75% of the cardiac cycle) will be selected for successive processing as it allows a relative motion free visualization of the main vessels and the myocardium.
Fasting patients will undergo a test for coronary calcium by CT; calcium scoring analysis will be done post image data acquisition using the manufacturer's software. Nitroglycerine will be administered in all patients (sublingual administration prior to CCTA initiation). CT acquisitions will be prospectively ECG-gated (30-80% of the cardiac cycle). The acquisition begins with a scout scan to identify the borders of the heart to minimize the field of view and exposure to the patient. A bolus of 60 mL nonionic contrast agent is then injected followed by 60 mL of saline at a rate of 4 mL/s to enhance signal from coronary arteries and blood chambers. In case of irregular heart rate, beta-blockers can be provided to keep optimal heart rate \~65-70 bpm. Trans-axial images are reconstructed by means of a filtered back-projection algorithm.
Patients will be asked to fast for 24 hours prior to the test. Before the resting perfusion phase, a single low-dose CT-based transmission scan is acquired for attenuation correction (AC) of all subsequent acquisitions. AC-CT images are automatically registered to the perfusion images, visually verified and manually corrected if necessary. Resting perfusion imaging started with the intravenous injection of a single bolus of 82Rb. Pharmacological stress imaging is obtained after adenosine infusion (140 μg/kg/min) through a peripheral vein, followed by a second dose of 82Rb. Image reconstruction is achieved by means of ordered subset expectation maximization (OSEM) iterative method. The hemodynamic responses to rest/stress tests are collected in terms of mean heart rate, mean blood systolic pressures and diastolic at rest and stress. Dynamic, gated and ungated trans-axial reconstructions are saved in DICOM format for further analysis and processing.
Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
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.
Time frame: Up to 3 months
Vessel-specific quantification of myocardial blood flow RFR
Ratio of absolute hyperemic MBFs (abnormal / normal) measured in mL/min/g.
Time frame: Up to 3 months
Absolute myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
Absolute myocardial blood flow (MBF) measured in ml/min/gm provides incremental diagnostic and prognostic information over relative perfusion alone.
Time frame: Up to 3 months
Myocardial flow reserve (MFR) measurement comparing non-invasive to the traditional approaches
Myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone.
Time frame: Up to 3 months
Fractional Flow Reserve (FFR) measurement comparing non-invasive to the traditional approaches
FFR calculates the maximum flow down a vessel in the presence of stenosis compared to maximum flow in the hypothetical absence of the stenosis.
Time frame: Up to 3 months
Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio
Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio will be calculated
Time frame: Up to 3 months
Distal/proximal pressure ratio
Distal/proximal pressure ratio will be calculated
Time frame: Up to 3 months
Discriminatory power of dPET/CTA. And FFR(CTA)
Predictive discriminatory power of each technique will be compared to ICA (FFR)
Time frame: Up to 3 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All PET imaging data, All CTA imaging data, Invasive Coronary Angiography (ICA) static images used for measurements, all processing and measurements made from all imaging data, patient pertinent demographics and clinical data, as well as dictionary of database formats will be shared.
Supporting information: Study protocol, Sap
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Emory University