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Focused, low tube potential, coronary calcium assessment prior to coronary CT angiography: A prospective, randomized clinical trial.
Crimm, HA, Fergestrom, NM, Dye, C, Philip, C, Nguyen, BT, Villines, TC
Journal of cardiovascular computed tomography. 2021;(3):240-245
Abstract
BACKGROUND Coronary artery calcium (CAC) scanning is commonly performed before coronary CT angiography (CTA) based partly on its potential to influence CTA scan parameters. Encompassing the whole heart and performed at high tube potential (120 kVp), standard (Agatston) CAC scanning adds to patient radiation exposure. Most CAC exists in the proximal and mid coronary segments and is easily visualized at low kVp. METHODS We tested the impact of a modified calcium scan on coronary CTA acquisition decision-making and image quality in a randomized clinical trial. Providers documented planned CTA acquisition parameters prior to CAC scanning in a blinded manner. Standard Agatston CAC scans proceeded in typical fashion whereas modified scans utilized 80 kVp and reduced z-axis length focused on the proximal-to-mid coronary arteries. CTA providers reviewed the CAC burden then documented final acquisition parameters. RESULTS The study included 172 patients (48% female; mean age 59 ± 6.7). As planned, the calcium scan effective dose was significantly lower in the modified CAC scan group (0.14 vs. 0.74 mSv using a 0.014 k-factor or 0.26 vs. 1.38 mSv using a 0.026 k-factor; both p < 0.001). Initially selected CTA parameters were changed at an identical rate following visual CAC assessment (59%). There was no significant difference in coronary CTA image quality (median quality score = 4 in both groups, p = 0.26), noise (31.0 vs 31.4 HU; p = 0.81), or signal/noise ratio (17.9 vs 16.8; p = 0.26). CONCLUSIONS A low-kVp scan with focused field-of-view provides actionable information regarding the presence and severity of CAC prior to coronary CTA. Coronary CTA parameters based on patient variables are frequently modified after assessing CAC burden in the CTA suite. CLINICALTRIALS. GOV REGISTRATION NUMBER NCT02972242.
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Factors associated with participation in a short-term dietary intervention study among patients with established coronary artery disease: insights from the EVADE CAD trial.
Rubinfeld, G, Driggin, E, Woolf, K, Slater, J, Newman, JD, Heffron, S, Shah, B
Coronary artery disease. 2021;(3):258-260
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Abstract
Optimal management of patients with coronary artery disease (CAD) includes a heart healthy diet. We evaluated associations between patient characteristics with the decision to enroll in a dietary intervention study. The EVADE CAD trial was a randomized trial assessing the impact of eight weeks of a vegan versus AHA-recommended diet on inflammatory and glucometabolic profiles in patients with angiographically-defined CAD. Characteristics of subjects who provided informed consent to participate in EVADE CAD but did not attend the initial visit and were not enrolled (n=40) were compared to those who were compliant with the visit and enrolled in the trial (n=100). After multivariable adjustment, lower body mass index (OR 0.89 [0.81–0.97)], p=0.01), active tobacco use (OR 6.0 [1.5–24.9], p=0.01), and greater number of vessels with CAD (OR 1.8 [1.1–3.0], p=0.03) were independent predictors of non-enrollment. These results identify discrete characteristics that may be predictive of lower engagement in dietary interventions.
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Efficacy of Histidine-Tryptophan-Ketoglutarate Solution Versus Blood Cardioplegia in Cardiac Surgical Procedures: A Randomized Controlled | Parallel Group Study.
Ali, I, Hassan, A, Shokri, H, Khorshed, R
The heart surgery forum. 2021;(1):E170-E176
Abstract
BACKGROUND In cardiac surgery, myocardial protection is required during cross-clamping followed by reperfusion. The use of cardioplegic solutions helps preserve myocardial energy stores, hindering electrolyte disturbances and acidosis during periods of myocardial ischaemia. This study aimed to compare the efficacy and safety between the histidine-tryptophan-ketoglutarate (HTK) solution and blood cardioplegia in various cardiac surgeries. METHODS Three-hundred-twenty patients aged 30-70 years old undergoing various cardiac surgeries were randomized into the HTK group and the blood cardioplegia group. The ventilation time, total bypass time, cross-clamp time, length of intensive care unit (ICU) or hospital stay, and postoperative complications were analyzed. RESULTS The total bypass time and cross-clamp time were significantly shorter in the HTK group than in the blood cardioplegia group (P < 0.001). Segmental wall motion abnormalities (SWMA) at postoperative echocardiography were significantly higher in in the blood cardioplegia group (P = 0.008). The number of patients requiring DC Shock was significantly higher in the HTK group (P < 0.001). The number of patients requiring inotropic support was significantly higher in the blood cardioplegia group (P < 0.001). The length of ICU, hospital stay, and ventilation time were significantly longer in the blood cardioplegia group than in the HTK group (P = 0.004, P < 0.001, P < 0.001, respectively). The number of patients requiring prolonged ventilation was significantly higher in the blood cardioplegia group compared with the HTK group (P = 0.022). There was no significant difference between the study groups regarding electrocardiographic changes, 30-day mortality, and 30-day readmission. CONCLUSION The use of HTK cardioplegia was associated with significantly shorter cross-clamp time, bypass time, duration of mechanical ventilation, length of ICU stay, and length of hospital stay. It is associated with less incidence of postoperative segmental wall abnormalities and less need for inotropic support than blood cardioplegia. Custodiol cardioplegia is a safe and feasible option that can be used as an effective substitute for blood cardioplegia to enhance myocardial protection.
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Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial.
Watanabe, H, Domei, T, Morimoto, T, Natsuaki, M, Shiomi, H, Toyota, T, Ohya, M, Suwa, S, Takagi, K, Nanasato, M, et al
Cardiovascular intervention and therapeutics. 2021;(1):91-103
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Previously we briefly reported the effect of 1-month dual antiplatelet therapy (DAPT) for patients with high bleeding risk (HBR) receiving percutaneous coronary intervention (PCI) in the STOPDAPT-2 trial, but full analysis data have not been available. We conducted post hoc subgroup analysis regarding the effect of very short DAPT for HBR patients in STOPDAPT-2 trial. The primary endpoint was a 1-year composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and bleeding (TIMI major/minor bleeding) outcomes. Major secondary endpoints were 1-year cardiovascular composite endpoint and bleeding endpoint. HBR was defined by the academic research consortium (ARC) HBR criteria. Among the 3009 study patients, 1054 (35.0%) were classified as HBR and 1955 (65.0%) were as non-HBR. There were no significant interactions between HBR/non-HBR subgroups and the assigned DAPT group on the primary endpoint (HBR; 3.48% vs. 5.98%, HR 0.57, 95% CI 0.32-1.03, and non-HBR; 1.81% vs. 2.36%, HR 0.78, 95% CI 0.42-1.45; P for interaction = 0.48), the major secondary cardiovascular endpoint (HBR; 3.07% vs. 4.03%, HR 0.77, 95% CI 0.40-1.48, and non-HBR; 1.41% vs. 1.61%, HR 0.89, 95% CI 0.43-1.84; P for interaction = 0.77), and the major secondary bleeding endpoint (HBR; 0.41% vs. 2.71%, HR 0.15, 95% CI 0.03-0.65, and non-HBR; 0.40% vs. 0.85%, HR 0.48, 95% CI 0.14-1.58; P for interaction = 0.22). In conclusion, the effects of 1-month DAPT for the primary and major secondary endpoints were consistent in HBR and non-HBR patients without any significant interactions. The benefit of 1-month DAPT in reducing major bleeding was numerically greater in HBR patients.Clinical trial registration Short and optimal duration of dual antiplatelet therapy after everolimus-eluting cobalt-chromium stent-2 [STOPDAPT-2]; NCT02619760.
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Mediterranean Diet Reduces Atherosclerosis Progression in Coronary Heart Disease: An Analysis of the CORDIOPREV Randomized Controlled Trial.
Jimenez-Torres, J, Alcalá-Diaz, JF, Torres-Peña, JD, Gutierrez-Mariscal, FM, Leon-Acuña, A, Gómez-Luna, P, Fernández-Gandara, C, Quintana-Navarro, GM, Fernandez-Garcia, JC, Perez-Martinez, P, et al
Stroke. 2021;(11):3440-3449
Abstract
BACKGROUND AND PURPOSE Lifestyle and diet affect cardiovascular risk, although there is currently no consensus about the best dietary model for the secondary prevention of cardiovascular disease. The CORDIOPREV study (Coronary Diet Intervention With Olive Oil and Cardiovascular Prevention) is an ongoing prospective, randomized, single-blind, controlled trial in 1002 coronary heart disease patients, whose primary objective is to compare the effect of 2 healthy dietary patterns (low-fat rich in complex carbohydrates versus Mediterranean diet rich in extra virgin olive oil) on the incidence of cardiovascular events. Here, we report the results of one secondary outcome of the CORDIOPREV study. Thus, to evaluate the efficacy of these diets in reducing cardiovascular disease risk. Intima-media thickness of both common carotid arteries (IMT-CC) was ultrasonically assessed bilaterally. IMT-CC is a validated surrogate for the status and future cardiovascular disease risk. METHODS From the total participants, 939 completed IMT-CC evaluation at baseline and were randomized to follow a Mediterranean diet (35% fat, 22% monounsaturated fatty acids, <50% carbohydrates) or a low-fat diet (28% fat, 12% monounsaturated fatty acids, >55% carbohydrates) with IMT-CC measurements at 5 and 7 years. We also analyzed the carotid plaque number and height. RESULTS The Mediterranean diet decreased IMT-CC at 5 years (−0.027±0.008 mm; P<0.001), maintained at 7 years (−0.031±0.008 mm; P<0.001), compared to baseline. The low-fat diet did not modify IMT-CC. IMT-CC and carotid plaquemax height were higher decreased after the Mediterranean diet, compared to the low-fat diet, throughout follow-up. Baseline IMT-CC had the strongest association with the changes in IMT-CC after the dietary intervention. CONCLUSIONS Long-term consumption of a Mediterranean diet rich in extravirgin olive oil, if compared to a low-fat diet, was associated with decreased atherosclerosis progression, as shown by reduced IMT-CC and carotid plaque height. These findings reinforce the clinical benefits of the Mediterranean diet in the context of secondary cardiovascular prevention. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT00924937.
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Central aortic hemodynamics following acute lower and upper-body exercise in a cold environment among patients with coronary artery disease.
Hintsala, HE, Valtonen, RIP, Kiviniemi, A, Crandall, C, Perkiömäki, J, Hautala, A, Mäntysaari, M, Alén, M, Ryti, N, Jaakkola, JJK, et al
Scientific reports. 2021;(1):2550
Abstract
Exercise is beneficial to cardiovascular health, evidenced by reduced post-exercise central aortic blood pressure (BP) and wave reflection. We assessed if post-exercise central hemodynamics are modified due to an altered thermal state related to exercise in the cold in patients with coronary artery disease (CAD). CAD patients (n = 11) performed moderate-intensity lower-body exercise (walking at 65-70% of HRmax) and rested in neutral (+ 22 °C) and cold (- 15 °C) conditions. In another protocol, CAD patients (n = 15) performed static (five 1.5 min work cycles, 10-30% of maximal voluntary contraction) and dynamic (three 5 min workloads, 56-80% of HRmax) upper-body exercise at the same temperatures. Both datasets consisted of four 30-min exposures administered in random order. Central aortic BP and augmentation index (AI) were noninvasively assessed via pulse wave analyses prior to and 25 min after these interventions. Lower-body dynamic exercise decreased post-exercise central systolic BP (6-10 mmHg, p < 0.001) and AI (1-6%, p < 0.001) both after cold and neutral and conditions. Dynamic upper-body exercise lowered central systolic BP (2-4 mmHg, p < 0.001) after exposure to both temperatures. In contrast, static upper-body exercise increased central systolic BP after exposure to cold (7 ± 6 mmHg, p < 0.001). Acute dynamic lower and upper-body exercise mainly lowers post-exercise central BP in CAD patients irrespective of the environmental temperature. In contrast, central systolic BP was elevated after static exercise in cold. CAD patients likely benefit from year-round dynamic exercise, but hemodynamic responses following static exercise in a cold environment should be examined further.Clinical trials.gov: NCT02855905 04/08/2016.
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The effects of rice bran oil on left ventricular systolic function, cardiometabolic risk factors and inflammatory mediators in men with coronary artery disease: a randomized clinical trial.
Mahdavi-Roshan, M, Salari, A, Ghorbani, Z, Nikpey, Z, Haghighatkhah, M, Fakhr Mousavi, A, Gholipour, M, Pourfarzad, A
Food & function. 2021;(10):4446-4457
Abstract
BACKGROUND/OBJECTIVE In the current study, we aimed to explore the effects of rice bran oil (RBO) in adjunct to conventional medical therapy on left ventricular ejection fraction (LVEF), cardiometabolic risk factors, and inflammatory mediators in male patients with coronary artery disease (CAD). SUBJECTS/METHODS The present randomized controlled trial included 40 men diagnosed with CAD (mean age = 55.76 years) who were randomly allocated into two groups to receive either 30 grams per day of RBO (intervention group) or sunflower oil (control group) plus a standard diet for eight weeks. At the initial visit, demographic and anthropometric data and blood samples were collected. LVEF levels and serum concentrations of lipid profile, glucose, uric acid, hs-CRP, and TNF-α were investigated. RESULTS A total of 37 participants completed the study (n = 18 in the intervention group, n = 19 in the control group). Analysis of covariance (ANCOVA) adjusted for baseline values, age and body mass index revealed that RBO significantly improved LVEF (51.34%) and reduced triglyceride (125.01 mg dl-1), blood sugar (110.4 mg dl-1), total cholesterol (123.01 mg dl-1) and low density lipoprotein (56.88 mg dl-1) levels compared to sunflower oil ((45.56%), (155.93 mg dl-1), (128.94 mg dl-1), (163.93 mg dl-1) and (83.79 mg dl-1), respectively) following a 8-week trial (P-values < 0.05). Additionally, the test demonstrated that RBO consuming patients had significantly lower levels of serum uric acid (4.60 mg dl-1), TNF-α (6.99 ng L-1) and hs-CRP (2.11 mg L-1) compared to the control group ((5.92 mg dl-1), (15.23 ng L-1), (4.47 mg L-1), respectively) (P-value < 0.05). However, no significant changes were found regarding weight, blood pressure or serum HDL levels throughout the trial. CONCLUSION Consumption of 30 grams per day RBO within a standard diet could be considered an effective non-pharmacological approach in improving LVEF, cardiometabolic risk factors, and inflammatory state in CAD. However, future trials are recommended for more clarification.
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The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial.
Wlosinska, M, Nilsson, AC, Hlebowicz, J, Hauggaard, A, Kjellin, M, Fakhro, M, Lindstedt, S
BMC complementary medicine and therapies. 2020;(1):132
Abstract
BACKGROUND One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. This study aimed to evaluate whether aged garlic extract (AGE) can influence coronary artery calcification (CAC) and to predict the individual effect of AGE using a standard process for data mining (CRISP-DM). METHOD This was a single-center parallel randomized controlled study in a university hospital in Europe. Patients were randomized, in a double-blind manner, through a computer-generated randomization chart. Patients with a Framingham risk score ≥ 10 after CT scan (n = 104) were randomized to an intake of placebo or AGE (2400 mg daily) for 1 year. Main outcome measures were changes in CAC score and secondary outcome measures changes in blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers. RESULT 104 patients were randomized and 46 in the active group and 47 in the placebo group were analyzed. There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and IL-6 (OR 2.56 [1.00-6.53]) in favor of the active group. There was also a significant (p = 0.027) decrease in systolic blood pressure in the AGE group, from a mean of 148 (SD: 19) mmHg at 0 months, to 140 (SD: 15) mmHg after 12 months. The AGE Algorithm, at a selected probability cut-off value of 0.5, the accuracy score for CAC progression was 80%, precision score of 79% and recall score 83%. The score for blood pressure was 74% (accuracy, precision and recall). There were no side-effects in either group. CONCLUSIONS AGE inhibits CAC progression, lowers IL-6, glucose levels and blood pressure in patients at increased risk of cardiovascular events in a European cohort. An algorithm was made and was used to predict with 80% precision which patient will have a significantly reduced CAC progression using AGE. The algorithm could also predict with a 74% precision which patient will have a significant blood pressure lowering effect pressure using AGE. TRIAL REGISTRATION Clinical trials NCT03860350, retrospectively registered (1/32019).
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Effects of crocin and saffron aqueous extract on gene expression of SIRT1, AMPK, LOX1, NF-κB, and MCP-1 in patients with coronary artery disease: A randomized placebo-controlled clinical trial.
Abedimanesh, N, Motlagh, B, Abedimanesh, S, Bathaie, SZ, Separham, A, Ostadrahimi, A
Phytotherapy research : PTR. 2020;(5):1114-1122
Abstract
This trial evaluated the potential impacts of saffron aqueous extract (SAE) and its main carotenoid on some of the atherosclerosis-related gene expression and serum levels of oxidized low-density cholesterol (ox-LDL) and Monocyte chemoattractant protein 1 (MCP-1) in patients with coronary artery disease (CAD). Participants of this randomized controlled trial included 84 CAD patients who categorized into three groups: Group 1 received crocin (30 mg/day), Group 2 SAE (30 mg/day), and Group 3 placebo for 8 weeks. Gene expression of Sirtuin 1 (SIRT1), 5'-adenosine monophosphate-activated protein kinase (AMPK), Lectin-like oxidized LDL receptor 1 (LOX1), nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB), and MCP-1 in peripheral blood mononuclear cells assessed by real-time PCR. Furthermore, serum ox-LDL and MCP-1 levels measured at the beginning and end of the intervention. Compared with the placebo group, gene expression of SIRT1 and AMPK increased significantly in the crocin group (p = .001), and the expression of LOX1 and NF-κB decreased significantly (p = .016 and .004, respectively). Serum ox-LDL levels decreased significantly in the crocin group after the intervention (p = .002) while MCP-1 levels decreased both in crocin and SAE groups (p = .001). Crocin may have beneficial effects on CAD patients by increasing the gene expression of SIRT1 and AMPK and decreasing the expression of LOX1 and NF-κB.
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Comparing the effects of ketorolac and Paracetamol on postoperative pain relief after coronary artery bypass graft surgery. A randomized clinical trial.
Javaherforooshzadeh, F, Abdalbeygi, H, Janatmakan, F, Gholizadeh, B
Journal of cardiothoracic surgery. 2020;(1):80
Abstract
INTRODUCTION Pain management after coronary artery bypass graft (CABG) surgery remains challenging. OBJECTIVE This study aimed to compare the effects of Ketorolac and Paracetamol on postoperative CABG pain relief. METHOD This double-blind randomized clinical trial study was conducted in Ahvaz, Iran, from September 2018-December 2019. Two consecutive groups of 60 patients undergoing elective on-pump coronary artery bypass graft surgery. INTERVENTION The patients were divided into 0.5 mg/kg of ketorolac mg/dl and 10 mg/kg of Paracetamol after surgery for pain management. Primary outcomes were: visual analog pain scale (VAS) at the time point immediately after extubation (baseline) and at 6, 12, 24 and 48 h and the total dose of morphine consumption. Secondary outcomes included the hemodynamic variables, weaning time, chest tube derange, in-hospital mortality and myocardial infarction. STATISTICAL ANALYSIS The data were analyzed using SPSS version 22(SPSS, Chicago, IL). The Mann-Whitney U-test was used to compare demographic data, VAS scores, vital signs, and side effects. Repeated measurements were tested within groups using Friedman's ANOVA and the Wilcoxon rank-sum test. Values were expressed as means ± standard deviations. Statistical significance was defined as a p-value < 0.05. RESULTS Compared with baseline scores, there were significant declines in VAS scores in both groups throughout the time sequence (P< 0.05). The statistical VAS score was slightly higher in the Paracetamol group at most time points, except for the time of 6 h. However, at 24 and 48 h, the VAS score in group Paracetamol was significantly higher than in group Ketorolac. There were no significant differences between groups about hemodynamic variables. CONCLUSION The efficacy of ketorolac is comparable to that of Paracetamol in postoperative CABG pain relief. TRIAL REGISTRY IRCT20150216021098N5. Registered at 2019-09-12.