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Design and rationale of the randomized trial of comprehensive lifestyle modification, optimal pharmacological treatment and utilizing PET imaging for quantifying and managing stable coronary artery disease (the CENTURY study).
Kitkungvan, D, Johnson, NP, Kirkeeide, R, Haynie, M, Carter, C, Patel, MB, Bui, L, Madjid, M, Mendoza, P, Roby, AE, et al
American heart journal. 2021;:135-146
Abstract
BACKGROUND The literature reports no randomized trial in chronic coronary artery disease (CAD) of a comprehensive management strategy integrating intense lifestyle management, maximal medical treatment to specific goals and high precision quantitative cardiac positron emission tomography (PET) for identifying high mortality risk patients needing essential invasive procedures. We hypothesize that this comprehensive strategy achieves greater risk factor reduction, lower major adverse cardiovascular events and fewer invasive procedures than standard practice. METHODS The CENTURY Study (NCT00756379) is a randomized-controlled-trial study in patients with stable or at high risk for CAD. Patients are randomized to standard of care (Standard group) or intense comprehensive lifestyle-medical treatment to targets and PET guided interventions (Comprehensive group). Comprehensive Group patients are regularly consulted by the CENTURY team implementing diet/lifestyle/exercise program and medical treatment to target risk modification. Cardiac PET at baseline, 24-, and 60-months quantify the physiologic severity of CAD and guide interventions in the Comprehensive group while patients and referring physicians of the Standard group are blinded to PET results. The primary end-point is the CENTURY risk score reduction during 5 years follow-up. The secondary endpoint is a composite of death, non-fatal myocardial infarction, stroke, and coronary revascularization. CONCLUSIONS The CENTURY Study is the first study in stable CAD to test the incremental benefit of a comprehensive strategy integrating intense lifestyle modification, medical treatment to specific goals, and high-precision quantitative myocardial perfusion imaging to guide revascularization. A total of 1028 patients have been randomized, and the 5 years follow-up will conclude in 2022.
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Could Omega 3 fatty acids reduce the risk of contrast-induced nephropathy in patients undergoing coronary angiography? A randomized controlled trial.
Alrowaie, FA, Almatham, KI, Alsamadi, F, Bashir, MS, Munshi, HH
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia. 2021;(2):328-335
Abstract
Contrast medium-induced nephropathy (CIN) is a leading cause of acquired acute kidney injury and has been associated with prolonged hospitalization and adverse clinical outcomes. This study aimed to determine if omega 3 fatty acids reduce the risk of CIN in patients with chronic kidney disease undergoing coronary angiography. A total of 130 consecutive patients undergoing coronary angiography were randomly assigned to one of two groups as follows: 67 patients were assigned to the N-acetylcysteine (NAC; 1200 mg) and 63 patients were assigned to the omega 3 fatty acid (4 g). Both drugs were administered orally twice per day one day before and on the day of contrast administration. Of the 130 patients enrolled in this study, 10 (7.7%) experienced an increase of at least 0.5 mg/dL (44 μmol/L) in serum creatinine levels 48 h after administration of the contrast agent including 5 of the 67 patients in the NAC group (7.5%) and 5 of the 63 patients in the omega 3 fatty acids group (7.9%; P = 0.919). There were no significant differences in the need for renal replacement therapy (3.0% vs. 9.5%, P = 0.121) or in the mortality rate (3.0% vs. 6.3%, P = 0.361) between the two groups. Short-term prophylactic omega 3 fatty acid treatment with hydration does not reduce the risk of CIN in patients with chronic kidney disease undergoing coronary angiography.
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Impact of iodine concentration and iodine delivery rate on contrast enhancement in coronary CT angiography: a randomized multicenter trial (CT-CON).
Rengo, M, Dharampal, A, Lubbers, M, Kock, M, Wildberger, JE, Das, M, Niezen, A, van Tilborg, F, Kofflard, M, Laghi, A, et al
European radiology. 2019;(11):6109-6118
Abstract
OBJECTIVE To compare the effect of contrast medium iodine concentration on contrast enhancement, heart rate, and injection pressure when injected at a constant iodine delivery rate in coronary CT angiography (CTA). METHODS One thousand twenty-four patients scheduled for coronary CTA were prospectively randomized to receive one of four contrast media: iopromide 300 mg I/ml, iohexol 350 mg I/ml, iopromide 370 mg I/ml, or iomeprol 400 mg I/ml. Contrast media were delivered at an equivalent iodine delivery rate of 2.0 g I/s. Intracoronary attenuation was measured and compared (per vessel and per segment). Heart rate before and after contrast media injection was documented. Injection pressure was recorded (n = 403) during contrast medium injection and compared between groups. RESULTS Intracoronary attenuation values were similar for the different contrast groups. The mean attenuation over all segments ranged between 384 HU for 350 mg I/ml and 395 HU for 400 mg I/ml (p = 0.079). Dose-length product (p = 0.8424), signal-to-noise ratio (all p > 0.05), time to peak (p = 0.324), and changes in heart rate (p = 0.974) were comparable between groups. The peak pressures differed: 197.4 psi for 300 mg I/ml (viscosity 4.6 mPa s), 229.8 psi for 350 mg I/ml (10.4 mPa s), 216.1 psi for 370 mg I/ml (9.5 mPa s), and 243.7 psi for 400 mg I/ml (12.6 mPa s) (p < 0.0001). CONCLUSION Intravascular attenuation and changes in heart rate are independent of iodine concentration when contrast media are injected at the same iodine delivery rate. Differences in injection pressures are associated with the viscosity of the contrast media. KEY POINTS • The contrast enhancement in coronary CT angiography is independent of the iodine concentration when contrast media are injected at body temperature (37 °C) with the same iodine delivery rate. • Iodine concentration does not influence the change in heart rate when contrast media are injected at identical iodine delivery rates. • For a fixed iodine delivery rate and contrast temperature, the viscosity of the contrast medium affects the injection pressure.
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Left ventricular end-diastolic pressure-guided hydration for the prevention of contrast-induced acute kidney injury in patients with stable ischemic heart disease: the LAKESIDE trial.
Marashizadeh, A, Sanati, HR, Sadeghipour, P, Peighambari, MM, Moosavi, J, Shafe, O, Firouzi, A, Zahedmehr, A, Maadani, M, Shakerian, F, et al
International urology and nephrology. 2019;(10):1815-1822
Abstract
OBJECTIVES Contrast-induced acute kidney injury (CI-AKI) is a serious complication in patients undergoing diagnostic cardiac angiography or percutaneous coronary intervention. We aimed to evaluate the preventive effects of left ventricular end-diastolic pressure (LVEDP)-guided hydration for the prevention of CI-AKI in patients with chronic kidney disease undergoing cardiac catheterization. METHODS This prospective randomized single-blind clinical trial enrolled 114 eligible patients with an estimated glomerular filtration rate (eGFR) of 15 < eGFR ≤ 60 mL/min/1.73 m2 [according to the level-modified Modification of Diet in Renal Disease formula (MDRD)] and stable ischemic heart disease undergoing coronary procedures. The patients were randomly allocated 1:1 into the LVEDP-guided hydration group (n = 57) or the standard hydration group (n = 57). CI-AKI was defined as a greater than 25% or greater than 0.5 mg/dL (44.2 mmol/L) increase in the serum creatinine concentration compared with the baseline value. Hydration with 0.9% sodium chloride at a rate of 1 mL/kg/h (0.5 mL/kg/h if left ventricular ejection fraction < 40%) within 12 h was given to all the patients in both groups before the procedure. In the LVEDP-guided group, the hydration infusion rate was adjusted according to the LVEDP level during and after the procedure. RESULTS The incidence of CI-AKI was 7.01% (4/57) in the LVEDP-guided group vs 3.84% (2/52) in the standard hydration group (summary odds ratio 0.53, 95% CI 0.093-3.022; P = 0.463). Major adverse cardiac events, hemodialysis, or related deaths occurred in neither of the groups during hospitalization or the 30-day follow-up. CONCLUSIONS In the present study, LVEDP-guided fluid administration, by comparison with standard hydration, failed to offer protection against the risk of CI-AKI in patients with renal insufficiency undergoing coronary angiography with or without percutaneous coronary intervention.
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Quantitative coronary plaque analysis predicts high-risk plaque morphology on coronary computed tomography angiography: results from the ROMICAT II trial.
Liu, T, Maurovich-Horvat, P, Mayrhofer, T, Puchner, SB, Lu, MT, Ghemigian, K, Kitslaar, PH, Broersen, A, Pursnani, A, Hoffmann, U, et al
The international journal of cardiovascular imaging. 2018;(2):311-319
Abstract
Semi-automated software can provide quantitative assessment of atherosclerotic plaques on coronary CT angiography (CTA). The relationship between established qualitative high-risk plaque features and quantitative plaque measurements has not been studied. We analyzed the association between quantitative plaque measurements and qualitative high-risk plaque features on coronary CTA. We included 260 patients with plaque who underwent coronary CTA in the Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography (ROMICAT) II trial. Quantitative plaque assessment and qualitative plaque characterization were performed on a per coronary segment basis. Quantitative coronary plaque measurements included plaque volume, plaque burden, remodeling index, and diameter stenosis. In qualitative analysis, high-risk plaque was present if positive remodeling, low CT attenuation plaque, napkin-ring sign or spotty calcium were detected. Univariable and multivariable logistic regression analyses were performed to assess the association between quantitative and qualitative high-risk plaque assessment. Among 888 segments with coronary plaque, high-risk plaque was present in 391 (44.0%) segments by qualitative analysis. In quantitative analysis, segments with high-risk plaque had higher total plaque volume, low CT attenuation plaque volume, plaque burden and remodeling index. Quantitatively assessed low CT attenuation plaque volume (odds ratio 1.12 per 1 mm3, 95% CI 1.04-1.21), positive remodeling (odds ratio 1.25 per 0.1, 95% CI 1.10-1.41) and plaque burden (odds ratio 1.53 per 0.1, 95% CI 1.08-2.16) were associated with high-risk plaque. Quantitative coronary plaque characteristics (low CT attenuation plaque volume, positive remodeling and plaque burden) measured by semi-automated software correlated with qualitative assessment of high-risk plaque features.
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Efficacy of alprostadil in preventing contrast-induced nephropathy in patients undergoing percutaneous coronary intervention: A multicenter prospective randomized controlled trial.
Liang, M, Yang, S, Fu, N, Lu, C, Tian, F, Xing, X, Lin, W, Liu, J
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2018;(4):742-750
Abstract
BACKGROUND The role of alprostadil on the prevention of contrast-induced nephropathy (CIN) still remains controversial. The purpose of this study was to examine the effects of short-term alprostadil on the incidence of CIN in patients undergoing elective percutaneous coronary intervention (PCI). METHODS A total of 480 patients with coronary heart disease undergoing PCI were enrolled in our study and randomly assigned to two groups. The control group (n = 240) was given only hydration therapy and the alprostadil group (n = 240) received intravenous administration of 20 ug/day (diluted with 100 ml normal saline) from 0.5∼1 hr before to 3 days after operation on the basis of hydration. The primary endpoint of the study was the incidence of CIN, which was defined as an increase in SCr concentration ≥ 44.2 umol/l or ≥25% above baseline within 48 hr∼72 hr after exposure of contrast media. RESULTS The incidence of CIN was significantly lower in the alprostadil group than that in the control group (6.25% vs 11.67%, P = 0.038). Multivariate logistic regression analysis showed that alprostadil was the protective factor of CIN (OR = 0.699, 95% CI 0.542-0.902, P = 0.006). The benefits against CIN were consistent in prespecified high-risk patients with diabetes mellitus (P = 0.003). In addition, we also found that hs-CRP and blood homocysteine values after PCI were significantly lower in the alprostadil group than those in the control group. CONCLUSION Prophylactic administration of alprostadil may prevent against CIN in coronary heart disease patients undergoing elective PCI, particularly in high-risk patients with diabetes mellitus.
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Identification of Patients With Stable Chest Pain Deriving Minimal Value From Noninvasive Testing: The PROMISE Minimal-Risk Tool, A Secondary Analysis of a Randomized Clinical Trial.
Fordyce, CB, Douglas, PS, Roberts, RS, Hoffmann, U, Al-Khalidi, HR, Patel, MR, Granger, CB, Kostis, J, Mark, DB, Lee, KL, et al
JAMA cardiology. 2017;(4):400-408
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IMPORTANCE Guidelines recommend noninvasive testing for patients with stable chest pain, although many subsequently have normal test results and no adverse clinical events. OBJECTIVE To describe a risk tool developed to use only pretest clinical data to identify patients with chest pain with normal coronary arteries and no clinical events during follow-up (minimal-risk cohort). DESIGN, SETTING, AND PARTICIPANTS This secondary analysis of a randomized, pragmatic comparative effectiveness trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]) includes stable, symptomatic outpatients without known coronary artery disease referred for noninvasive testing at 193 sites in North America. INTERVENTIONS Patients were randomized to receive coronary computed tomography angiography (CCTA) vs functional testing. MAIN OUTCOMES AND MEASURES A low-risk tool was developed and internally validated from July 27, 2010, to September 19, 2013, in 4631 patients receiving CCTA as their initial test, with a median follow-up of 25 months. Logistic regression analysis was used to evaluate pretest variables to determine factors associated with minimal risk using a two-thirds random sample for model derivation (n = 3087) and a one-third sample for testing and validation (n = 1544). The model was then applied to the CCTA and functional testing arms, and test results and event rates were ascertained. RESULTS A total of 1243 of 4631 patients (26.8%) were in the minimal-risk cohort. The final minimal-risk model included 10 clinical variables that together were correlated with normal CCTA results and no clinical events (C statistic = 0.725 for the derivation and validation subsets; 95% CI, 0.705-0.746): younger age; female sex; racial or ethnic minority; no history of hypertension, diabetes, or dyslipidemia; family history of premature coronary artery disease; never smoking; symptoms unrelated to physical or mental stress; and higher high-density lipoprotein cholesterol level. Across the entire PROMISE cohort, this model was associated with the lowest rates of severely abnormal test results (1.3% for CCTA; 5.6% for functional) and cardiovascular death or myocardial infarction (0.5% for a median of 25 months) among patients at the highest probability (10th decile) of minimal risk. CONCLUSIONS AND RELEVANCE In contemporary practice, more than 25% of patients with stable chest pain referred for noninvasive testing will have normal coronary arteries and no long-term clinical events. A clinical tool using readily available pretest variables discriminates such minimal-risk patients, for whom deferred testing may be considered. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01174550.
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Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial.
Achenbach, S, Paul, JF, Laurent, F, Becker, HC, Rengo, M, Caudron, J, Leschka, S, Vignaux, O, Knobloch, G, Benea, G, et al
European radiology. 2017;(2):821-830
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OBJECTIVES To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. METHODS In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. RESULTS Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. CONCLUSIONS With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. KEY POINTS • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.
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Prognostic Value of Coronary Artery Calcium in the PROMISE Study (Prospective Multicenter Imaging Study for Evaluation of Chest Pain).
Budoff, MJ, Mayrhofer, T, Ferencik, M, Bittner, D, Lee, KL, Lu, MT, Coles, A, Jang, J, Krishnam, M, Douglas, PS, et al
Circulation. 2017;(21):1993-2005
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BACKGROUND Coronary artery calcium (CAC) is an established predictor of future major adverse atherosclerotic cardiovascular events in asymptomatic individuals. However, limited data exist as to how CAC compares with functional testing (FT) in estimating prognosis in symptomatic patients. METHODS In the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain (or dyspnea) and intermediate pretest probability for obstructive coronary artery disease were randomized to FT (exercise electrocardiography, nuclear stress, or stress echocardiography) or anatomic testing. We evaluated those who underwent CAC testing as part of the anatomic evaluation (n=4209) and compared that with results of FT (n=4602). We stratified CAC and FT results as normal or mildly, moderately, or severely abnormal (for CAC: 0, 1-99 Agatston score [AS], 100-400 AS, and >400 AS, respectively; for FT: normal, mild=late positive treadmill, moderate=early positive treadmill or single-vessel ischemia, and severe=large ischemic region abnormality). The primary end point was all-cause death, myocardial infarction, or unstable angina hospitalization over a median follow-up of 26.1 months. Cox regression models were used to calculate hazard ratios (HRs) and C statistics to determine predictive and discriminatory values. RESULTS Overall, the distribution of normal or mildly, moderately, or severely abnormal test results was significantly different between FT and CAC (FT: normal, n=3588 [78.0%]; mild, n=432 [9.4%]; moderate, n=217 [4.7%]; severe, n=365 [7.9%]; CAC: normal, n=1457 [34.6%]; mild, n=1340 [31.8%]; moderate, n=772 [18.3%]; severe, n=640 [15.2%]; P<0.0001). Moderate and severe abnormalities in both arms robustly predicted events (moderate: CAC: HR, 3.14; 95% confidence interval, 1.81-5.44; and FT: HR, 2.65; 95% confidence interval, 1.46-4.83; severe: CAC: HR, 3.56; 95% confidence interval, 1.99-6.36; and FT: HR, 3.88; 95% confidence interval, 2.58-5.85). In the CAC arm, the majority of events (n=112 of 133, 84%) occurred in patients with any positive CAC test (score >0), whereas fewer than half of events occurred in patients with mildly, moderately, or severely abnormal FT (n=57 of 132, 43%; P<0.001). In contrast, any abnormality on FT was significantly more specific for predicting events (78.6% for FT versus 35.2% for CAC; P<0.001). Overall discriminatory ability in predicting the primary end point of mortality, nonfatal myocardial infarction, and unstable angina hospitalization was similar and fair for both CAC and FT (C statistic, 0.67 versus 0.64). Coronary computed tomographic angiography provided significantly better prognostic information compared with FT and CAC testing (C index, 0.72). CONCLUSIONS Among stable outpatients presenting with suspected coronary artery disease, most patients experiencing clinical events have measurable CAC at baseline, and fewer than half have any abnormalities on FT. However, an abnormal FT was more specific for cardiovascular events, leading to overall similarly modest discriminatory abilities of both tests. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01174550.
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Efficacy of nicorandil treatment for prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization: A prospective randomized controlled trial.
Iranirad, L, Hejazi, SF, Sadeghi, MS, Jang, SA
Cardiology journal. 2017;(5):502-507
Abstract
BACKGROUND Contrast-induced nephropathy (CIN) remains to be a potentially serious complication of radiographic procedures and is the third leading cause of the acute kidney injury (AKI) among hospitalized patients. This clinical trial was performed to assess the preventive effect of oral nicorandil on CIN in high-risk patients undergoing cardiac catheterization. METHODS In this prospective, randomized, controlled trial, 128 patients with at least two risk factors for CIN undergoing elective percutaneous coronary intervention (PCI) were randomly assigned to either the nicorandil group or the control group. Patients in the nicorandil group (n = 64) received 10 mg nicorandil, daily from 30 min before and up to 3 days after procedure and intravenous hydration for 2 h before and 6 h after the procedure, whereas patients in the control group (n = 64) just received intravenous hydration. Serum creatinine (SCr) was measured before contrast exposure and at 72 h. CIN was defined as an increase of 25% in SCr or > 0.5 mg/dL 72 h after contrast administration. RESULTS Contrast-induced nephropathy occurred in 14 out of 64 (21.9%) patients in the control group and in 3 out of 64 (4.7%) patients in the nicorandil group. There was a significant difference in the incidence of CIN between the two groups at 72 h after administering the radiocontrast agent (p = 0.008). Moreover, there were significant differences between the two groups in SCr and estimated glomerular filtration rate 72 h after radiocontrast administration (p < 0.05). CONCLUSIONS The findings revealed that oral nicorandil had substantial efficacy over hydration protocol for the development of CIN in high-risk patients undergoing cardiac catheterization.