scholarly journals Measuring effects on intima-media thickness: an evaluation of rosuvastatin in Chinese subjects with subclinical atherosclerosis—design, rationale, and methodology of the METEOR-China study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yilong Wang ◽  
Anxin Wang ◽  
Hongwei Li ◽  
Zhanquan Li ◽  
Bo Hu ◽  
...  
Keyword(s):  
Subclinical Atherosclerosis ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Rate Of Change ◽  
Double Blind ◽  
Media Thickness ◽  
Safety Parameters ◽  
Study Sites ◽  
Chinese Subjects ◽  
China Study

Abstract Background The beneficial effect of statins on atherosclerosis and cardiovascular outcomes has been well established. The Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin (METEOR) global study demonstrated that a 2-year orally administered treatment with rosuvastatin 40 mg daily significantly slowed the progression of carotid intima-media thickness (CIMT) compared to placebo. The current METEOR-China study is designed to evaluate the effect of rosuvastatin 20 mg daily versus placebo on the progression of atherosclerosis measured by CIMT in asymptomatic Chinese subjects. Methods This is a phase 3, randomised, double-blind, placebo-controlled, multicentre parallel-group study. Asymptomatic Chinese subjects with a 10-year ischaemic cardiovascular disease (ICVD) risk < 10% will be recruited at 25 study sites. They will be treated with rosuvastatin 20 mg or placebo for 104 weeks. The primary endpoint is the annualised rate of change in CIMT measured by B-mode ultrasonography. Secondary endpoints include the annualised rate of change in CIMT at three different sections of the carotid artery and changes in the serum lipid profile. Safety parameters will also be assessed. Conclusion The study will evaluate whether rosuvastatin 20 mg slows the progression of CIMT in asymptomatic Chinese subjects at low risk of ICVD. Trial registration ClinicalTrials.gov NCT02546323. Registered on September 10, 2015

Effects of lutein and lycopene on carotid intima–media thickness in Chinese subjects with subclinical atherosclerosis: a randomised, double-blind, placebo-controlled trial

2013 ◽  
Vol 111 (3) ◽  
pp. 474-480 ◽  
Author(s):  
Zhi-Yong Zou ◽  
Xian-Rong Xu ◽  
Xiao-Ming Lin ◽  
Hua-Bin Zhang ◽  
Xin Xiao ◽  
...  
Keyword(s):  
Synergistic Effects ◽  
Controlled Trial ◽  
Subclinical Atherosclerosis ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Combination Group ◽  
Double Blind ◽  
Mean Values ◽  
Media Thickness ◽  
Chinese Subjects

The aim of the present study was to evaluate the effects of lutein and lycopene supplementation on carotid artery intima–media thickness (CAIMT) in subjects with subclinical atherosclerosis. A total of 144 subjects aged 45–68 years were recruited from local communities. All the subjects were randomly assigned to receive 20 mg lutein/d (n 48), 20 mg lutein/d+20 mg lycopene/d (n 48) or placebo (n 48) for 12 months. CAIMT was measured using Doppler ultrasonography at baseline and after 12 months, and serum lutein and lycopene concentrations were determined using HPLC. Serum lutein concentrations increased significantly from 0·34 to 1·96 μmol/l in the lutein group (P< 0·001) and from 0·35 to 1·66 μmol/l in the combination group (P< 0·001). Similarly, serum lycopene concentrations increased significantly from 0·18 to 0·71 μmol/l in the combination group at month 12 (P< 0·001), whereas no significant change was observed in the placebo group. The mean values of CAIMT decreased significantly by 0·035 mm (P= 0·042) and 0·073 mm (P< 0·001) in the lutein and combination groups at month 12, respectively. The change in CAIMT was inversely associated with the increase in serum lutein concentrations (P< 0·05) in both the active treatment groups and with that in serum lycopene concentrations (β = − 0·342, P= 0·031) in the combination group. Lutein and lycopene supplementation significantly increased the serum concentrations of lutein and lycopene with a decrease in CAIMT being associated with both concentrations. In addition, the combination of lutein and lycopene supplementation was more effective than lutein alone for protection against the development of CAIMT in Chinese subjects with subclinical atherosclerosis, and further studies are needed to confirm whether synergistic effects of lutein and lycopene exist.

Abstract 194: Rosuvastatin Reduces Progression of Carotid Atherosclerosis within 12 Months of Treatment: The METEOR Trial

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Michiel L Bots ◽  
Joel S Raichlen ◽  
Gregory W Evans ◽  
Mike K Palmer ◽  
Daniel H O’Leary ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Controlled Trial ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Rate Of Change ◽  
Double Blind ◽  
Atherosclerosis Progression ◽  
Media Thickness ◽  
The Difference ◽  
The Individual

Background: In several statin trials, vascular event rates for treatment groups begin to separate 1 year after commencement of treatment. For atherosclerosis progression, the temporal sequence of the effect has not been defined. We sought to determine the earliest time point at which significant differences in atherosclerosis progression rates were detectable after initiation of statin therapy using data from the METEOR trial (Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin). Methods: METEOR was a double-blind, randomized, placebo-controlled trial among 984 low risk subjects, which studied the effect of LDL lowering with 40 mg rosuvastatin on the rate of change in carotid intima media thickness (CIMT) over time. Ultrasound assessments were made at 12 carotid artery sites at baseline and every 6 months up to two years. In these analyses, the data were cut at 6 months, 1 year, and 18 months, and compared with analysis of all data at 2 years, using the same statistical method. Results: The difference in rate of maximum CIMT progression for all carotid artery sites (primary endpoint - near and far walls of the left and right common carotid artery [CCA], carotid bulb and internal carotid artery) between the rosuvastatin and placebo groups was apparent 6 months after baseline (0.0023 mm/yr and 0.0106 mm/yr, respectively p =0.36). After 12 months CIMT progression rates were significantly different between groups: 0.0032 mm/yr and 0.0133 mm/yr (p=0.049). This divergence grew with further follow-up: − 0.0009 mm/yr and 0.0131 mm/yr after 18 months (p<0.0001), and − 0.0014 mm/yr and 0.0131 mm/yr after 24 months of treatment (p<<178>0.0001). For the individual carotid artery segments, significant differences were seen at 12 months for the mean CIMT of the CCA, and at 18 months for the maximum CIMT of the bulb and the CCA. Conclusion: Aggressive LDL lowering with rosuvastatin exerts its beneficial effect on atherosclerosis during the first year of treatment, which parallels the timing of event rate reduction seen in clinical trials. These findings suggest that, in trials examining the effects of treatment on CIMT progression, a duration of 12 months may be adequate, given sufficient sample size, high precision of measurements, and treatment effect.

Abstract 2648: Design of Carotid Intima-Media Thickness Trials

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Gregory W Evans ◽  
Mike K Palmer ◽  
Daniel H O’Leary ◽  
John R Crouse ◽  
Michiel L Bots ◽  
...  
Keyword(s):  
Sample Size ◽  
Treatment Effect ◽  
Subclinical Atherosclerosis ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Double Blind ◽  
Aged Patients ◽  
Media Thickness ◽  
The Impact

Carotid artery intima-media thickness (CIMT) assessed by B-mode ultrasound is an accepted marker for subclinical atherosclerosis commonly used in clinical trials. Their sample size and power calculations apply 2-sample independent t-tests and within group variance in progression rates from the literature. However, this approach obscures the impact of differences in study designs including length of follow-up and differences in the number of and interval between ultrasound scans. These effects can be assessed using common sample size formula for longitudinal models, but this approach requires decomposition of the total variance into between and within subject components that have not generally been reported in the literature. Here, we derive these variance components for the Measuring Effects on intima-media Thickness: an Evaluation of Rosuvastatin (METEOR) study, a randomized, double-blind trial that demonstrated treatment with 40 mg rosuvastatin significantly slowed CIMT progression in middle-aged patients with a low Framingham risk of coronary heart disease and subclinical atherosclerosis (baseline maximum CIMT ≥1.2-<3.5mm). We examined the impact of differing follow-up periods, use of intermediate scans, and use of duplicate scans using both sample size calculations and actual analyses based on subsets of the METEOR data. Reductions in study length or number of scans result in increased variances and larger sample sizes to detect a given treatment effect. Table shows the impact of duplicate scans at baseline and end of the 2-year study, with and without intermediate scans performed every 6 months, on the sample size required to detect a treatment effect of 0.012 mm/year. These results underscore the importance of considering the number and spacing of ultrasound exams explicitly during study design, and suggest that reductions in scanning frequency may seriously erode study power and/or increase costs by requiring recruitment of additional subjects.

Subclinical atherosclerosis in children and adolescents with congenital heart disease

2020 ◽  
pp. 1-8
Author(s):  
Silvia M. Cardoso ◽  
Michele Honicky ◽  
Yara M. F. Moreno ◽  
Luiz R. A. de Lima ◽  
Matheus A. Pacheco ◽  
...  
Keyword(s):  
Risk Factors ◽  
Congenital Heart Disease ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Clinical Characteristics ◽  
Congenital Heart ◽  
Subclinical Atherosclerosis ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Media Thickness

Abstract Background: Subclinical atherosclerosis in childhood can be evaluated by carotid intima-media thickness, which is considered a surrogate marker for atherosclerotic disease in adulthood. The aims of this study were to evaluate carotid intima-media thickness and, to investigate associated factors. Methods: Cross-sectional study with children and adolescents with congenital heart disease (CHD). Socio-demographic and clinical characteristics were assessed. Subclinical atherosclerosis was evaluated by carotid intima-media thickness. Cardiovascular risk factors, such as physical activity, screen time, passive smoke, systolic and diastolic blood pressure, waist circumference, dietary intake, lipid parameters, glycaemia, and C-reactive protein, were also assessed. Factors associated with carotid intima-media thickness were analysed using multiple logistic regression. Results: The mean carotid intima-media thickness was 0.518 mm and 46.7% had subclinical atherosclerosis (carotid intima-media thickness ≥ 97th percentile). After adjusting for confounding factors, cyanotic CHD (odds ratio: 0.40; 95% confidence interval: 0.20; 0.78), cardiac surgery (odds ratio: 3.17; 95% confidence interval: 1.35; 7.48), and be hospitalised to treat infections (odds ratio: 1.92; 95% confidence interval: 1.04; 3.54) were associated with subclinical atherosclerosis. Conclusion: Clinical characteristics related to CHD were associated with subclinical atherosclerosis. This finding suggests that the presence of CHD itself is a risk factor for subclinical atherosclerosis. Therefore, the screen and control of modifiable cardiovascular risk factors should be made early and intensively to prevent atherosclerosis.

scholarly journals Meta-analysis of epigenome-wide association studies of carotid intima-media thickness

2021 ◽  
Author(s):  
Eliana Portilla-Fernández ◽  
Shih-Jen Hwang ◽  
Rory Wilson ◽  
Jane Maddock ◽  
W. David Hill ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Disease ◽  
Dna Methylation ◽  
Cardiovascular Risk ◽  
Cardiovascular Risk Factors ◽  
Association Studies ◽  
Subclinical Atherosclerosis ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Media Thickness

AbstractCommon carotid intima-media thickness (cIMT) is an index of subclinical atherosclerosis that is associated with ischemic stroke and coronary artery disease (CAD). We undertook a cross-sectional epigenome-wide association study (EWAS) of measures of cIMT in 6400 individuals. Mendelian randomization analysis was applied to investigate the potential causal role of DNA methylation in the link between atherosclerotic cardiovascular risk factors and cIMT or clinical cardiovascular disease. The CpG site cg05575921 was associated with cIMT (beta = −0.0264, p value = 3.5 × 10–8) in the discovery panel and was replicated in replication panel (beta = −0.07, p value = 0.005). This CpG is located at chr5:81649347 in the intron 3 of the aryl hydrocarbon receptor repressor gene (AHRR). Our results indicate that DNA methylation at cg05575921 might be in the pathway between smoking, cIMT and stroke. Moreover, in a region-based analysis, 34 differentially methylated regions (DMRs) were identified of which a DMR upstream of ALOX12 showed the strongest association with cIMT (p value = 1.4 × 10–13). In conclusion, our study suggests that DNA methylation may play a role in the link between cardiovascular risk factors, cIMT and clinical cardiovascular disease.

scholarly journals AB0258 CAROTID INTIMA-MEDIA THICKNESS AND SERUM BIOMARKERS IN PARAGUAYAN PATIENTS WITH RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1428.2-1428
Author(s):  
V. Valinotti ◽  
A. Paats ◽  
R. Acosta ◽  
L. Roman ◽  
I. Acosta-Colman ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Disease Duration ◽  
Subclinical Atherosclerosis ◽  
High Sensitivity ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Serum Biomarkers ◽  
Carotid Plaques ◽  
Media Thickness ◽  
Hs Crp

Background:The mechanism of increased cardiovascular risk in RA is not well understood and is independent of traditional CV risk factors. Intima-media thickness of the common carotid wall measured by ultrasonogram is a safe and useful biomarker of early stage atherosclerosis that correlates with coronary involvement; and it correlates with severity and duration of disease. Several studies have shown a relationship between inflammation markers, endothelial dysfunction markers, and carotid involvement. (1)Objectives:To determine the presence of inflammation biomarkers and its relationship with subclinical atherosclerosis measured by carotid ultrasound, and with the clinical characteristics in patients with established Rheumatoid Arthritis (RA)Methods:Descriptive, cross sectional, prospective study, in a Paraguayan cohort of patients with RA meeting ACR/EULAR2010 criteria. This study had two phases: the first one, included a standardized questionnaire according to the variables included in the Cardiovascular Risk project (PINV15-0346), from the National Sciences and Technology Council (CONACYT), and physical examination; the second one included laboratory sample collection performed by a specialized laboratory for serum biomarkers measurement for cardiovascular risk prediction (i.e endothelin, alpha-TNF, E-selectin, homocysteine, apolipoprotein, fibrinogen, and high sensitivity-CRP levels) and carotid ultrasound evaluation by a trained specialist, to evaluate subclinical atherosclerosis. Subclinical atherosclerosis was defined as carotid intima-media thickness (CIMT) >0,9mm and/or presence of carotid plaques. All patients signed informed consent. SPSS 23rd version was used for data analysis. Quantitative variables were presented as means and qualitative as frequencies. Chi square test was performed for comparisons between dichotomous variables and t Student for continuous, and p ≤ 0.05 for statistical significance.Results:100 patients were included, 87% were women, mean disease duration 130.9±102.64 months, 77% were RF positive, and 84.4% were ACPA positive, 43.4% had bone erosions, mean ESR-DAS28 was 3,42±1,1; 30% had remission criteria. 39% had extra-articular manifestations.Elevated serum biomarkers were found: fibrinogen >400 mg/dL 88.2%, high sensitivity-CRP (hs-CRP) >5mg/dL 42.9%, endothelin >2 ng/mL 20%, alpha-TNF >15,6 pg/mL 13.1%, E-selectin >79,2 ng/mL 6%. 25.3% had CIMT >0,9 mm and mean CIMT was 0.68±0.25mm. 27.14% had carotid plaques. Patients with CIMT>1mm had higher frequency of family history of arterial hypertension (p=0.006), greater mean disease duration (p=0.0007), hip circumference (p=0.014), blood pressure (SBP p=0.038, DBP p=0.027), HAQ levels (p=0,019) and hs-CRP levels (p=0.013), also lower mean height (p=0,04); while carotid plaques were related to higher homocysteine (p=0.026) and hs-CRP levels (p=0.024).Conclusion:A considerable percentage of patients had subclinical atherosclerosis. Patients with CIMT>0,9mm had a longer disease duration, higher HAQ levels, hip circumference, as well as higher BP. High levels of hs-CRP were more frequently related to the presence of subclinical atherosclerosisReferences:[1]Aday, A. targeting residual inflammatory risk: a shifting paradigm for atherosclerotic disease. Frontiers in cardiovascular medicine. 2019. 6:16.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6403155/pdf/fcvm-06-00016.pdfDisclosure of Interests:None declared

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