Impact of iterative reconstruction vs. filtered back projection on image quality in 320-slice CT coronary angiography: Insights from the CORE320 multicenter study

Abstract Iterative reconstruction has been shown to reduce image noise compared with traditional filtered back projection with quantum denoising software (FBP/QDS+) in CT imaging but few comparisons have been made in the same patients without the influence of interindividual factors. The objective of this study was to investigate the impact of adaptive iterative dose reduction in 3-dimensional (AIDR 3D) and FBP/QDS+-based image reconstruction on image quality in the same patients. We randomly selected 100 patients enrolled in the coronary evaluation using 320-slice CT study who underwent CT coronary angiography using prospectively electrocardiogram triggered image acquisition with a 320-detector scanner. Both FBP/QDS+ and AIDR 3D reconstructions were performed using original data. Studies were blindly analyzed for image quality by measuring the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR). Image quality was assessed qualitatively using a 4-point scale. Median age was 63 years (interquartile range [IQR]: 56–71) and 72% were men, median body mass index 27 (IQR: 24–30) and median calcium score 222 (IQR: 11–644). For all regions of interest, mean image noise was lower for AIDR 3D vs. FBP/QDS+ (31.69 vs. 34.37, P ≤ .001). SNR and CNR were significantly higher for AIDR 3D vs. FBP/QDS+ (16.28 vs. 14.64, P < .001 and 19.21 vs. 17.06, P < .001, respectively). Subjective (qualitative) image quality scores were better using AIDR 3D vs. FBP/QDS+ with means of 1.6 and 1.74, respectively (P ≤ .001). Assessed in the same individuals, iterative reconstruction decreased image noise and raised SNR/CNR as well as subjective image quality scores compared with traditional FBP/QDS+ in 320-slice CT coronary angiography at standard radiation doses

Lectin‐Like Oxidized Low‐Density Lipoprotein Receptor 1 Inhibition in Type 2 Diabetes: Phase 1 Results

Background Blockade of the lectin‐like oxidized low‐density lipoprotein receptor‐1 (LOX‐1) is a potentially attractive mechanism for lowering inflammatory and lipid risk in patients with atherosclerosis. This study aims to assess the safety, tolerability, and target engagement of MEDI6570, a high‐affinity monoclonal blocking antibody to LOX‐1. Methods and Results This phase 1, first‐in‐human, placebo‐controlled study (NCT03654313) randomized 88 patients with type 2 diabetes to receive single ascending doses (10, 30, 90, 250, or 500 mg) or multiple ascending doses (90, 150, or 250 mg once monthly for 3 months) of MEDI6570 or placebo. Primary end point was safety; secondary and exploratory end points included pharmacokinetics, immunogenicity, free soluble LOX‐1 levels, and change in coronary plaque volume. Mean age was 57.6/58.1 years in the single ascending doses/multiple ascending doses groups, 31.3%/62.5% were female, and mean type 2 diabetes duration was 9.7/8.7 years. Incidence of adverse events was similar among cohorts. MEDI6570 exhibited nonlinear pharmacokinetics, with terminal half‐life increasing from 4.6 days (30 mg) to 11.2 days (500 mg), consistent with target‐mediated drug disposition. Dose‐dependent reductions in mean soluble LOX‐1 levels from baseline were observed (>66% at 4 weeks and 71.61–82.96% at 10 weeks in the single ascending doses and multiple ascending doses groups, respectively). After 3 doses, MEDI6570 was associated with nonsignificant regression of noncalcified plaque volume versus placebo (−13.45 mm3 versus −8.25 mm3). Conclusions MEDI6570 was well tolerated and demonstrated dose‐dependent soluble LOX‐1 suppression and a pharmacokinetic profile consistent with once‐monthly dosing. Registration URL: https://clinicaltrials.gov/; Unique identifier: NCT03654313

Nuclear stress perfusion imaging versus computed tomography coronary angiography for identifying patients with obstructive coronary artery disease as defined by conventional angiography: insights from the CorE-64 multicenter study

We investigated the diagnostic accuracy of computed tomography angiography (CTA) versus myocardial perfusion imaging (MPI) for detecting obstructive coronary artery disease (CAD) as defined by conventional quantitative coronary angiography (QCA). Sixty-three patients who were enrolled in the CorE-64 multicenter study underwent CTA, MPI, and QCA imaging. All subjects were referred for cardiac catheterization with suspected or known coronary artery disease. The diagnostic accuracy of quantitative CTA and MPI for identifying patients with 50% or greater coronary arterial stenosis by QCA was evaluated using receiver operating characteristic (ROC) analysis. Pre-defined subgroups were patients with known CAD and those with a calcium score of 400 or over. Diagnostic accuracy by ROC analysis revealed greater area under the curve (AUC) for CTA than MPI for all 63 patients: 0.95 [95% confidence interval (CI): 0.89-0.100] vs 0.65 (95%CI: 0.53-0.77), respectively (P<0.01). Sensitivity, specificity, positive and negative predictive values were 0.93, 0.95, 0.97, 0.88, respectively, for CTA and 0.85, 0.45, 0.74, 0.63, respectively, for MPI. In 48 patients without known CAD, AUC was 0.96 for CTA and to 0.67 for SPECT (P<0.01). There was no significant difference in AUC for CTA in patients with calcium score below 400 versus over 400 (0.93 vs 0.95), but AUC was different for SPECT (0.61 vs 0.95; P<0.01). In a direct comparison, CTA is markedly superior to MPI for detecting obstructive coronary artery disease in patients. Even in subgroups traditionally more challenging for CTA, SPECT does not offer similarly good diagnostic accuracy. CTA may be considered the non-invasive test of choice if diagnosis of obstructive CAD is the purpose of imaging

Influence of image acquisition settings on radiation dose and image quality in coronary angiography by 320-detector volume computed tomography: the CORE320 pilot experience

The objective of this study was to investigate the impact of image acquisition settings and patients’ characteristics on image quality and radiation dose for coronary angiography by 320-row computed tomography (CT). CORE320 is a prospective study to investigate the diagnostic performance of 320-detector CT for detecting coronary artery disease and associated myocardial ischemia. A run-in phase in 65 subjects was conducted to test the adequacy of the computed tomography angiography (CTA) acquisition protocol. Tube current, exposure window, and number of cardiac beats per acquisition were adjusted according to subjects’ gender, heart rate, and body mass index (BMI). Main outcome measures were image quality, assessed by contrast/noise measurements and qualitatively on a 4-point scale, and radiation dose, estimated by the dose-length-product. Average heart rate at image acquisition was 55.0±7.3 bpm. Median Agatston calcium score was 27.0 (interquartile range 1-330). All scans were prospectively triggered. Single heart beat image acquisition was obtained in 61 of 65 studies (94%). Sixty-one studies (94%) and 437 of 455 arterial segments (96%) were of diagnostic image quality. Estimated radiation dose was significantly greater in obese (5.3±0.4 mSv) than normal weight (4.6±0.3 mSv) or overweight (4.7±0.3 mSv) subjects (P&amp;lt;0.001). BMI was the strongest factor influencing image quality (odds ratio=1.457, P=0.005). The CORE320 CTA image acquisition protocol achieved a good balance between image quality and radiation dose for a 320-detector CT system. However, image quality in obese subjects was reduced compared to normal weight subjects, possibly due to tube voltage/current restrictions mandated by the study protocol

Patient Characteristics as Predictors of Image Quality and Diagnostic Accuracy of MDCT Compared With Conventional Coronary Angiography for Detecting Coronary Artery Stenoses: CORE-64 Multicenter International Trial

OBJECTIVE. The purpose of the study was to investigate patient characteristics associated with image quality and their impact on the diagnostic accuracy of MDCT for the detection of coronary artery stenosis. MATERIALS AND METHODS. Two hundred ninety-one patients with a coronary artery calcification (CAC) score of <= 600 Agatston units (214 men and 77 women; mean age, 59.3 +/- 10.0 years [SD]) were analyzed. An overall image quality score was derived using an ordinal scale. The accuracy of quantitative MDCT to detect significant (>= 50%) stenoses was assessed using quantitative coronary angiography (QCA) per patient and per vessel using a modified 19-segment model. The effect of CAC, obesity, heart rate, and heart rate variability on image quality and accuracy were evaluated by multiple logistic regression. Image quality and accuracy were further analyzed in subgroups of significant predictor variables. Diagnostic analysis was determined for image quality strata using receiver operating characteristic (ROC) curves. RESULTS. Increasing body mass index (BMI) (odds ratio [OR] = 0.89, p < 0.001), increasing heart rate (OR = 0.90, p < 0.001), and the presence of breathing artifact (OR = 4.97, p = 0.001) were associated with poorer image quality whereas sex, CAC score, and heart rate variability were not. Compared with examinations of white patients, studies of black patients had significantly poorer image quality (OR = 0.58, p = 0.04). At a vessel level, CAC score (10 Agatston units) (OR = 1.03, p = 0.012) and patient age (OR = 1.02, p = 0.04) were significantly associated with the diagnostic accuracy of quantitative MDCT compared with QCA. A trend was observed in differences in the areas under the ROC curves across image quality strata at the vessel level (p = 0.08). CONCLUSION. Image quality is significantly associated with patient ethnicity, BMI, mean scan heart rate, and the presence of breathing artifact but not with CAC score at a patient level. At a vessel level, CAC score and age were associated with reduced diagnostic accuracy

Characterization of Peri-Infarct Zone Heterogeneity by Contrast-Enhanced Multidetector Computed Tomography: A Comparison With Magnetic Resonance Imaging

ObjectivesThis study examined whether multidetector computed tomography (MDCT) improves the ability to define peri-infarct zone (PIZ) heterogeneity relative to magnetic resonance imaging (MRI).BackgroundThe PIZ as characterized by delayed contrast-enhancement (DE)-MRI identifies patients susceptible to ventricular arrhythmias and predicts outcome after myocardial infarction (MI).MethodsFifteen mini-pigs underwent coronary artery occlusion followed by reperfusion. Both MDCT and MRI were performed on the same day approximately 6 months after MI induction, followed by animal euthanization and ex vivo MRI (n = 5). Signal density threshold algorithms were applied to MRI and MDCT datasets reconstructed at various slice thicknesses (1 to 8 mm) to define the PIZ and to quantify partial volume effects.ResultsThe DE-MDCT reconstructed at 8-mm slice thickness showed excellent correlation of infarct size with post-mortem pathology (r2= 0.97; p < 0.0001) and MRI (r2= 0.92; p < 0.0001). The DE-MDCT and -MRI were able to detect a PIZ in all animals, which correlates to a mixture of viable and nonviable myocytes at the PIZ by histology. The ex vivo DE-MRI PIZ volume decreased with slice thickness from 0.9 ± 0.2 ml at 8 mm to 0.2 ± 0.1 ml at 1 mm (p = 0.01). The PIZ volume/mass by DE-MDCT increased with decreasing slice thickness because of declining partial volume averaging in the PIZ, but was susceptible to increased image noise.ConclusionsA DE-MDCT provides a more detailed assessment of the PIZ in chronic MI and is less susceptible to partial volume effects than MRI. This increased resolution best reflects the extent of tissue mixture by histopathology and has the potential to further enhance the ability to define the substrate of malignant arrhythmia in ischemic heart disease noninvasively

The Absence of Coronary Calcification Does Not Exclude Obstructive Coronary Artery Disease or the Need for Revascularization in Patients Referred for Conventional Coronary Angiography

Objectives This study was designed to evaluate whether the absence of coronary calcium could rule out >= 50% coronary stenosis or the need for revascularization. Background The latest American Heart Association guidelines suggest that a calcium score (CS) of zero might exclude the need for coronary angiography among symptomatic patients. Methods A substudy was made of the CORE64 (Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors) multicenter trial comparing the diagnostic performance of 64-detector computed tomography to conventional angiography. Patients clinically referred for conventional angiography were asked to undergo a CS scan up to 30 days before. Results In all, 291 patients were included, of whom 214 (73%) were male, and the mean age was 59.3 +/- 10.0 years. A total of 14 (5%) patients had low, 218 (75%) had intermediate, and 59 (20%) had high pre-test probability of obstructive coronary artery disease. The overall prevalence of >= 50% stenosis was 56%. A total of 72 patients had CS = 0, among whom 14 (19%) had at least 1 >= 50% stenosis. The overall sensitivity for CS = 0 to predict the absence of >= 50% stenosis was 45%, specificity was 91%, negative predictive value was 68%, and positive predictive value was 81%. Additionally, revascularization was performed in 9 (12.5%) CS = 0 patients within 30 days of the CS. From a total of 383 vessels without any coronary calcification, 47 (12%) presented with >= 50% stenosis; and from a total of 64 totally occluded vessels, 13 (20%) had no calcium. Conclusions The absence of coronary calcification does not exclude obstructive stenosis or the need for revascularization among patients with high enough suspicion of coronary artery disease to be referred for coronary angiography, in contrast with the published recommendations. Total coronary occlusion frequently occurs in the absence of any detectable calcification. (Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors [CORE-64]; NCT00738218) (J Am Coll Cardiol 2010;55:627-34) (C) 2010 by the American College of Cardiology Foundatio

Diagnostic Performance of Combined Noninvasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-MDCT: The CT Angiography and Perfusion Methods of the CORE320 Multicenter Multinational Diagnostic Study

OBJECTIVE. Coronary MDCT angiography has been shown to be an accurate noninvasive tool for the diagnosis of obstructive coronary artery disease (CAD). Its sensitivity and negative predictive value for diagnosing percentage of stenosis are unsurpassed compared with those of other noninvasive testing methods. However, in its current form, it provides no information regarding the physiologic impact of CAD and is a poor predictor of myocardial ischemia. CORE320 is a multicenter multinational diagnostic study with the primary objective to evaluate the diagnostic accuracy of 320-MDCT for detecting coronary artery luminal stenosis and corresponding myocardial perfusion deficits in patients with suspected CAD compared with the reference standard of conventional coronary angiography and SPECT myocardial perfusion imaging. CONCLUSION. We aim to describe the CT acquisition, reconstruction, and analysis methods of the CORE320 study.Toshiba Medical System