Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent but their assent should be obtained using age appropriate information. Institutional Review Board (IRB) need paediatric expertise to balance the benefits and risks of research in children. The lack of consent has implications on the design, analysis and the choice of comparators used in the trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The children requires even more careful review. Children represent a vulne rable population with developmental, physiological and psychological differences from adults, which make age- and development-related research important for their benefit. Finally, criteria for the protection of children in clinical trials there fore need to be laid down. Specific protection should be defined for research performed in children, at all stages and ages.
Adult ; Child ; Ethics Committees, Research ; Humans ; Parents ; Research Personnel ; Risk Assessment

Ultraviolet (UV) irradiation is a relevant environment factor to induce cellular senescence and photoaging. Both autophagy- and silent information regulator T1 (SIRT1)-dependent pathways are critical cellular processes of not only maintaining normal cellular functions, but also protecting cellular senescence in skin exposed to UV irradiation. In the present studies, we investigated whether modulation of autophagy induction using a novel synthetic SIRT1 activator, heptasodium hexacarboxymethyl dipeptide-12 (named as Aquatide), suppresses the UVB irradiation-induced skin aging. Treatment with Aquatide directly activates SIRT1 and stimulates autophagy induction in cultured human dermal fibroblasts. Next, we found that Aquatide-mediated activation of SIRT1 increases autophagy induction via deacetylation of forkhead box class O (FOXO) 1. Finally, UVB irradiation-induced cellular senescence measured by SA-β-gal staining was significantly decreased in cells treated with Aquatide in parallel to occurring SIRT1 activation-dependent autophagy. Together, Aquatide modulates autophagy through SIRT1 activation, contributing to suppression of skin aging caused by UV irradiation.
Autophagy ; Cell Aging* ; Fibroblasts ; Humans ; Skin ; Skin Aging

BACKGROUND/AIMS: We evaluated the efficacy and safety and influence on glucose tolerance by different doses of pitavastatins in acute myocardial infarction (AMI) patients. METHODS: Consecutive 1,101 AMI patients who were enrolled in Livalo in Acute Myocardial Infarction Study (LAMIS)-II were randomly assigned to receive either 2 mg of pitavastatin or 4 mg of pitavastatin orally per day. Primary efficacy endpoint was composite of cardiac death, nonfatal myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina, heart failure or arrhythmic events at 12-month. RESULTS: There was no significant difference in primary efficacy endpoint between 2 mg and 4 mg groups (9.07% vs. 9.13%, p = 0.976). The degree of the reduction of low density lipoprotein cholesterol (LDL-C) was significantly greater in 4 mg group compared to 2 mg group from baseline to follow-up (–42.05 ± 32.73 mg/dL vs. –34.23 ± 31.66 mg/dL, p = 0.002). Fasting plasma glucose level was reduced significantly in both groups (–20.16 ± 54.49 mg/dL in 4 mg group and –24.45 ± 63.88 mg/dL in 2 mg group, p < 0.001 and p < 0.001, respectively) and there was no significant change of glycated hemoglobin in two groups from baseline to follow-up (–0.13% ± 1.21% in 4 mg group and –0.04% ± 1.10% in 2 mg group, p = 0.256 and p = 0.671, respectively). CONCLUSIONS: Although LDL-C was reduced more significantly by using 4 mg of pitavastatin compared to 2 mg of pitavastatin, the event rate was comparable without adverse effects on glucose tolerance in both groups in AMI patients who were enrolled in LAMIS-II.
Angina, Unstable ; Atherosclerosis ; Blood Glucose ; Cholesterol, LDL ; Death ; Fasting ; Follow-Up Studies ; Glucose ; Heart Failure ; Hemoglobin A, Glycosylated ; Hospitalization ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Myocardial Infarction*

BACKGROUND AND OBJECTIVES: Overt and subclinical hypothyroidism is known to be associated with developing atherosclerosis and adverse changes in blood lipid. There has been no data regarding the effects of a normal range of thyroid hormone on the presence of coronary atherosclerosis. SUBJECTS AND METHODS: We studied 1 25 consecutive patients (age: 60.0 +/-11.1 years, male: female=84:41) who underwent diagnostic coronary angiography. The clinical diagnoses on admission were stable angina (32.0%), unstable angina (53.6%), and acute myocardial infarction (14.4%). The thyroid hormones [thyroid stimulating hormone (TSH), free thyroxine and free 3 -iodothyronine], serum lipid levels, high sensitivity C-reactive protein (hsCRP) level, homocysteine and fibrinogen levels were measured. The coronary angiographic results were compared with laboratory findings. RESULTS: The angiographic diagnoses of coronary artery disease were no significant stenosis in 4 1 patients (32.8%), single vessel disease in 47 patients (37.6%) and multivessel disease in 37 patients (29.6%). The serum TSH levels showed a trend toward higher levels in the patients with multivessel disease compared to the patients with no significant stenosis (1.22+/-0.96 uIU/mL vs. 0.73+/-0.53 uIU/mL, respectively, p=0.053). According to the levels of TSH (<1.0 uIU/mL and > or =1.0 IU/mL), the incidence of multivessel disease was significantly higher in the patients with high serum TSH levels (23.1 % vs. 40.0%, respectively, p=0.038). A significant correlation was observed between the levels of TSH and the monocyte count (r=0.251, p=0.005), hsCRP level (r=0.208, p=0.023) and homocysteine level (r=0.279, p=0.002). CONCLUSION: The high level of serum TSH is associated with multivessel disease, abnormal inflammatory markers and high homocysteine levels.
Angina, Stable ; Angina, Unstable ; Arteriosclerosis ; Atherosclerosis ; C-Reactive Protein ; Constriction, Pathologic ; Coronary Angiography ; Coronary Artery Disease* ; Coronary Disease ; Diagnosis ; Fibrinogen ; Homocysteine ; Humans ; Hypothyroidism ; Incidence ; Male ; Monocytes ; Myocardial Infarction ; Reference Values ; Risk Factors* ; Thyroid Gland* ; Thyroid Hormones ; Thyroxine

Insulin resistance is an important risk factor for coronary artery disease. However, there has been no data regarding its clinical effect on the outcomes of percutaneous coronary intervention (PCI) in non-diabetic patients. We analyzed 98 non-diabetic consecutive patients (59+/-11.5 yr, male:female=63:35) who underwent elective coronary angiography. The patients were divided into two groups: Group I (n=71; the value of HOMA-IR [homeostasis model assessment of insulin resistance] <2.6) and Group II (n=27; the value of HOMA-IR > or = 2.6). In-hospital and 30-day major adverse cardiac events (MACE) were compared between the two groups. The concentrations of fasting insulin and triglyceride were significantly higher in Group II than in Group I. Significant correlations were observed between the value of HOMA-IR and body mass index (r=0.489, p<0.001), levels of total cholesterol (r=0.204, p=0.045), triglyceride (r=0.334, p=0.001) and apolipoprotein B (r=0.212, p=0.038). PCI was performed in 59 patients (60.2%). In-hospital and 30-day MACE were higher in Group II than Group I (2.4% vs. 27.8%, p=0.008; 2.4% vs. 27.8%, p=0.008). Multivariate analysis revealed that the value of HOMA-IR > or = 2.6 was an independent predictor of MACE. Increased HOMA-IR level is an important prognostic indicator in non-diabetic patients underwent PCI.
Prognosis ; Models, Biological ; Middle Aged ; Male ; *Insulin Resistance ; Humans ; Homeostasis ; Female ; Coronary Stenosis/blood/physiopathology/therapy ; Coronary Arteriosclerosis/blood/physiopathology/therapy ; *Angioplasty, Transluminal, Percutaneous Coronary/adverse effects ; Aged

BACKGROUND/AIMS: There are controversies surrounding strict control of blood glucose levels in diabetic patients. Therefore, we evaluated the influence of hypoglycemia at admission on the clinical outcomes of patients with acute myocardial infarction (AMI). METHODS: We analyzed 5,249 diabetic patients who enrolled in the Korean Acute Myocardial Infarction Registry from November 2005 to March 2013. The patients were divided into three groups according to their blood glucose level at admission; Group I: hypoglycemia (< or = 70 mg/dL), Group II: normoglycemia (70-140 mg/dL) and Group III: hyperglycemia (> or = 140 mg/dL). We assessed in-hospital mortality and the major adverse cardiac events based on blood glucose levels at admission. RESULTS: The mean age was older in group I at 72.6 +/- 11.0 years compared to 71.3 +/- 10.7 in group II and 70.3 +/- 11.1 in group III (p < 0.006). A total of 344 patients died during hospitalization. In-hospital mortality was higher in group I at 12.9%, compared to 5.2% in group II and 6.8% in group III (p < 0.006). Multivariable logistic regression analysis determined that the independent predictors of 1-month mortality were age, Killip class III-IV, cerebrovascular disease, chronic renal failure, acute renal failure, cardiogenic shock, ventricular tachycardia, ejection fraction < 40% and hypoglycemia in admission. The mortality rate at 1 month was significantly higher in group I compared to group II (odds ratio [OR] 3.571; 95% confidence interval [CI] 1.465-8.705, p = 0.005) compared to group II and group III (OR 4.088; 95% CI 1.757-9.511, p = 0.001). CONCLUSIONS: Hypoglycemia on admission was an important predictor of in-hospital and one-month mortality in AMI patients with diabetes mellitus.
Acute Kidney Injury ; Blood Glucose ; Diabetes Mellitus* ; Hospital Mortality ; Hospitalization ; Humans ; Hyperglycemia ; Hypoglycemia* ; Logistic Models ; Mortality ; Myocardial Infarction* ; Prognosis ; Renal Insufficiency, Chronic ; Shock, Cardiogenic ; Tachycardia, Ventricular

BACKGROUND/AIMS: There are controversies surrounding strict control of blood glucose levels in diabetic patients. Therefore, we evaluated the influence of hypoglycemia at admission on the clinical outcomes of patients with acute myocardial infarction (AMI). METHODS: We analyzed 5,249 diabetic patients who enrolled in the Korean Acute Myocardial Infarction Registry from November 2005 to March 2013. The patients were divided into three groups according to their blood glucose level at admission; Group I: hypoglycemia (< or = 70 mg/dL), Group II: normoglycemia (70-140 mg/dL) and Group III: hyperglycemia (> or = 140 mg/dL). We assessed in-hospital mortality and the major adverse cardiac events based on blood glucose levels at admission. RESULTS: The mean age was older in group I at 72.6 +/- 11.0 years compared to 71.3 +/- 10.7 in group II and 70.3 +/- 11.1 in group III (p < 0.006). A total of 344 patients died during hospitalization. In-hospital mortality was higher in group I at 12.9%, compared to 5.2% in group II and 6.8% in group III (p < 0.006). Multivariable logistic regression analysis determined that the independent predictors of 1-month mortality were age, Killip class III-IV, cerebrovascular disease, chronic renal failure, acute renal failure, cardiogenic shock, ventricular tachycardia, ejection fraction < 40% and hypoglycemia in admission. The mortality rate at 1 month was significantly higher in group I compared to group II (odds ratio [OR] 3.571; 95% confidence interval [CI] 1.465-8.705, p = 0.005) compared to group II and group III (OR 4.088; 95% CI 1.757-9.511, p = 0.001). CONCLUSIONS: Hypoglycemia on admission was an important predictor of in-hospital and one-month mortality in AMI patients with diabetes mellitus.
Acute Kidney Injury ; Blood Glucose ; Diabetes Mellitus* ; Hospital Mortality ; Hospitalization ; Humans ; Hyperglycemia ; Hypoglycemia* ; Logistic Models ; Mortality ; Myocardial Infarction* ; Prognosis ; Renal Insufficiency, Chronic ; Shock, Cardiogenic ; Tachycardia, Ventricular

Traumatic thoracic aortic injury is typically fatal. However, recent improvements in pre-hospital care and diagnostic modalities have resulted in an increased number of patients with traumatic aortic injury arriving alive at the hospital. Also, the morbidity and mortality associated with endovascular repair are significantly lower than with conventional open surgery in traumatic thoracic aorta injury. We experienced two cases of successful management of traumatic thoracic aortic dissection with endovascular stents caused by traffic accidents.
Accidents, Traffic ; Aorta, Thoracic ; Aortography ; Humans ; Multidetector Computed Tomography ; Stents

BACKGROUND AND OBJECTIVES: Non-high density lipoprotein-cholesterol (non-HDL-C) and apolipoprotein B (ApoB) are markers of atherosclerotic risk and predictors of cardiovascular events. The aim of this study was to evaluate clinical impact of non-HDL-C and ApoB on clinical outcomes in metabolic syndrome (MS) patients with acute myocardial infarction (AMI) undergoing percuatneous coronary intervetion. SUBJECTS AND METHODS: We analyzed 470 MS patients (64.4+/-12.0 years, 53.6% male) with AMI who were followed-up for 12-month after percutaneous coronary intervention (PCI) from December 2005 to January 2008 in a single center. These patients were divided into 2 groups based on median values of non-HDL-C and ApoB. We studied their baseline and follow-up relation with 12-month clinical outcomes, all-cause death and major adverse cardiac events (MACE). RESULTS: Mean values of baseline non-HDL-C and ApoB were 141.2+/-43.1 mg/dL and 99.3+/-29.0 mg/dL respectively. During 12-month follow-up 32 MACE (6.8%) and 12 deaths (2.5%) occurred. We observed significant correlation between non-HDL-C and ApoB. Twelve-month MACE and all-cause death after PCI showed no significant relation as non-HDL-C or ApoB levels increased. Follow-up patients (n=306, rate 65%) also did not show significant relation with clinical outcomes. Twelve-month MACE decreased as non-HDL-C and ApoB reduction rates increased. CONCLUSION: There was no significant association between higher non-HDL-C or ApoB and 12-month clinical outcomes in MS patients with AMI undergoing PCI. ApoB was found to be a better predictor of 12-month MACE than non-HDL-C based on their reduction rates.
Apolipoproteins ; Apolipoproteins B ; Cholesterol ; Follow-Up Studies ; Humans ; Myocardial Infarction ; Percutaneous Coronary Intervention

BACKGROUND/AIMS: It has been suggested that admission hyperglycemia is associated with poor clinical outcomes in patients with acute myocardial infarction (AMI). The aim of this study was to assess the relationship between admission hyperglycemia and short-long term prognosis in patients with AMI. METHODS: A total of 6,030 AMI patients without a previous history of diabetes were enrolled between Nov. 2005 and Jan. 2008. The patients were divided into three groups according to the levels of admission glucose levels: group I (<140 mg/dL, n=3,307), group II (140~199 mg/dL, n=1,946), and group III (> or =200 mg/dL, n=777). In-hospital and one-year mortality were compared among three the groups. RESULTS: The mean age was 64.3+/-13.3, 65.9+/-12.7, and 67.7+/-13.0 years in group I, II and III, respectively. The proportion of female gender (23.9%, 29.5%, 35.0%; p<0.001), Killip class III-IV (8.9%, 12.3%, 28.3%; p<0.001), ST-segment elevation myocardial infarction (54.6%, 71.5%, 71.7%; p<0.001), and in-hospital mortality (3.5%, 7.5%, 19.7%; p<0.001) increased with higher tertiles of elevated values of initial serum glucose. Hazard ratio (HR) for mortality rate were significantly increased in group II [HR=1.19, 95% confidential interval (Cl) 1.02~1.40, p=0.032], and in group III [HR=1.91, 95% Cl 1.59~2.30, p=0.001], compared with group I. And also significant differences were existed between group II and group III [HR =1.55, 95% Cl 1.27~1.88, p=0.001]. CONCLUSIONS: Admission glucose in patients with AMI provides incremental prognostic value, and significantly correlates with in-hospital and one-year mortalities.
Female ; Glucose ; Hospital Mortality ; Humans ; Hyperglycemia ; Myocardial Infarction ; Prognosis