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Carotid intima media thickness (IMT) and IMT-progression as predictors of vascular events in a high risk european population
No full textThe intima-media thickness (IMT) of extracranial carotid arteries, assessed by ultrasound techniques, has been shown to be associated with most vascular risk factors for atherosclerosis and with the prevalence and extent of cardiovascular disease and coronary atherosclerosis. On this basis, this ultrasonic variable has been proposed as a surrogate index of atherosclerosis of other vascular regions. Studies have supported this hypothesis showing that IMT is a good predictor of new myocardial infarction and stroke. However, limited information has been provided on the relationship between IMT-progression, that is the real end point used in pharmacological studies, and cardiovascular events. Generally, attempts to delay IMT-progression using "anti-atherosclerotic" agents have provided encouraging results. However, no one of the studies so far published has been able to address, on a prospective basis, whether IMT-progression may effectively reflect the efficacy of the treatment in reducing the rate of cardiovascular events. To address these issues we designed “the IMPROVE study”, a currently on going prospective multicenter, longitudinal, long-term, observational study funded by the European community. The major objective of the IMPROVE study is to evaluate the association between IMT, IMT-progression and the rate of new vascular events in subjects at high risk of atherosclerosis. The effect of gene polymorphisms, lipid peroxidation, socio-economic and psychological variables on the same ultrasonic end points will be also evaluated. In order to achieve the project objectives, 3600 patients will be recruited in 7 European countries and followed ultrasonically and clinically for 30 months. Clinical events will be monitored up to 36 months. Data will be analysed with conventional statistics and with innovative approaches based on artificial neural networks. The study is considered as positive if a difference of at least 3% in the cumulative incidence of acute vascular events between the lowest and the highest quintiles of IMT or IMT-progression is detected. A summary of aims and design of the study will be presented
CAROTID INTIMA MEDIA THICKNESS (IMT) AND IMT-PROGRESSION AS PREDICTORS OF VASCULAR EVENTS IN A HIGH RISK EUROPEAN POPULATION: “THE IMPROVE STUDY”
No full textIssue with models of integration : "The IMPROVE Study"
No full textEpidemiological and clinical evidence indicates that < 50% of cardiovascular events are explained by vascular risk factors (VRFs), thus justifying for the need of alternative or integrated biomarkers to better stratify the patient risk. The intima-media thickness (IMT) of extracranial carotid arteries, measured by high-resolution B-mode ultrasound, is widely used to investigate the effects of conventional and non-conventional VRFs as well as the association with end-organ damage. In view of its correlation with coronary atherosclerosis, IMT has been proposed as an useful surrogate marker of atherosclerosis in carotid arteries and in other vascular regions. IMT is a good predictor of new myocardial infarction and it has been shown to be influenced by drugs known to reduce cardiovascular events, which supports the concept that IMT represents a biomarker of atherosclerosis. Carotid IMT alone has the same predictive capacity of VRFs. In a longitudinal - observational study, we have shown that the integrated use of VRFs included into the Framingham risk score and ultrasonic measurements of carotid IMT significantly increase their capacity to predict cardiovascular events in patients at low/intermediate risk. The integration of carotid IMT with non conventional VRFs (gene polymorphisms, oxidative burden, psyco or socioeconomic aspects etc.) may further optimize the stratification of patient risk. Another important carotid ultrasonic variable that may have predictive capacity, alone or when integrated with conventional or non conventional risk factors, is the progression of carotid IMT. A prospective, multicenter, longitudinal, long-term, observational study (The IMPROVE study) is currently ongoing. It aims to investigate the capacity of both cross sectional carotid IMT and overall IMT-progression to predict alone, or after integration with both conventional and non conventional VRF, the rate of new vascular events in an European population classified at high risk of cardiovascular disease for the presence of at least 3 VRFs. The patients’ enrolment ended in April 2005 and a total of 3711 patients were recruited in 6 European countries (1095 in Italy, 504 in France and 2140 in northern Europe).
Funding: Research describing correlations between carotid and coronary atherosclerosis is supported by the Italian Ministry of Health. The improve study is supported by European Union (IMPROVE: QLG1-CT-2002-00896)
References:
1. Measurement of carotid artery intima-media thickness in dyslipidemic patients increases the power of traditional risk factors to predict cardiovascular events. Baldassarre D, Amato M, Pustina L, Castelnuovo S, sancito S; Gerosa L; Veglia F, Keidar S, Tremoli E, Sirtori CR. Atherosclerosis. 2006 May 6; [Epub ahead of print].
2. Carotid intima media thickness (IMT) and IMT-progression as predictors of vascular events in a high risk european population: “the IMPROVE study”. Tremoli E, Baldassarre D, on behalf of the “IMPROVE Study Group”. Atherosclerosis. 2006;7(3):42.
3. Baldassarre D, Amato M, Bondioli A, Sirtori CR, Tremoli E. Carotid artery intima-media thickness measured by ultrasonography in normal clinical practice correlates well with atherosclerosis risk factors. Stroke 2000;31:2426-2430.
4. Baldassarre D, Amato M, Pustina L, Tremoli E, Sirtori CR, Calabresi L, Franceschini G. Increased carotid artery intima-media thickness in subjects with primary hypoalphalipoproteinemia. Arterioscler Thromb Vasc Biol 2002;22:317-322
Carotid IMT measurements: a comparison between s-VHS or cd-ROM recorded ultrasonic scans
No full textObjective: To assess whether the use of new B-mode imaging technologies, which allow the direct storage of series of single digitalized images in electronic supports (CD-rom) in place of movies continuously recorded on analogical supports (s-VHS videotapes), may compromise the accuracy, precision and repeatability of carotid artery intima media thickness (IMT) measurements.
Methods: The agreement between 121 replicated-scans stored as movies on s-VHS videotapes was compared with the agreement obtained with 121 replicated-scans stored as series of single frozen images on CD-rom.
Results: The intra-method agreement was highest with movies recorded on s-VHS videotapes, with a bias between log-transformed readings of 0.0017±0.0305, mean absolute difference of 0.0210±0.0222 and repeatability coefficient of 0.061. The digital system provided a slightly lower repeatability with a bias between readings of −0.0040±0.0343, mean absolute difference of 0.0266±0.0219 and repeatability coefficient of 0.069. When the two methods were compared, the log-transformed bias between readings was 0.0169±0.06 with higher values obtained with s-VHS, the repeatability coefficient being 0.124, with almost all points within ±2SD of the mean difference. The mean absolute difference between the two measurements was 0.042±0.046.
Conclusions: Compared with movies recorded on videotapes, the direct storage of series of single digitalized images in CD-rom for IMT evaluation associates with a lower agreement (-28%) between replicate scans. This implies the need of sample size larger of about 28% when this technology is used in IMT-progression clinical trials.
Funding: European Project, IMPROVE QLG1-CT-2002-00896
Carotid diameter improves the carotid IMT capacity to predict coronary events : data from the IMPROVE study
No full textObjective: to investigate whether measurement of carotid artery intima media thickness (IMT) could be combined with inter-adventitial common carotid artery diameter (CCAD) to improve the predictability of cardiovascular events.
Background: The “IMPROVE study” is a prospective, longitudinal study designed to investigate whether cross-sectional IMT and IMT progression are predictors of vascular events in European individuals at high risk of cardiovascular diseases.
Methods and results: 3711 subjects (median age 64.4 years; 48% men) with at least three vascular risk factors (VRFs) were recruited in 7 centers in Europe. 3703 patients were monitored for a median of 36.2 months. 215 patients suffered a first cardiovascular event with an incidence of 19.9 per 1000 person-years.
In Cox proportional-hazards regression, C-IMT measures were associated with the risk of the combined end point even after adjustment for VRFs (Ptrend <0.005 for all). CCAD was associated with the risk of events independently of VRFs and C-IMTmax (adjusted HR for 1 SD increase: 1.26, 95% CI: 1.08-1.48, p=0.004). Results for cardio and cerebro-vascular events were in line with those observed with the combined end point.
By ROC curves analysis, CCAD alone has about the same predictive capacity of the best predictor among C-IMT variables (IMTmean). When combined, IMTmean and CCAD provided a better predictive capacity than conventional VRFs (c-statistic = 0.653 vs. 0.639). The combination of IMTmean, CCAD and VRFs further improved the total predictive capacity (c-statistic 0.669).
Conclusions: CCAD and C-IMT are independent predictors of cardiovascular events and together they enhance the predictive capacity of VRFs
Carotid intima media thickness as marker of atherosclerosis : results of the IMPROVE Study
No full textThe intima-media thickness (IMT) of extracranial carotid arteries, measured by high-resolution B-mode ultrasound has been proposed as an useful surrogate marker of atherosclerosis in carotid arteries and in other vascular regions. IMT is a good predictor of new myocardial infarction and it has been shown to be infl uenced by drugs known to reduce cardiovascular events, which supports the concept that IMT represents a biomarker of atherosclerosis. Carotid IMT alone has the same predictive capacity of VRFs. In a longitudinal - observational study, we have shown that the integrated use of VRFs included into the Framingham risk score and ultrasonic measurements of carotid IMT significantly increase their capacity to predict cardiovascular events in patients at low/intermediate risk. The integration of carotid IMT with non conventional VRFs may further optimize the stratification of patient risk. Another important carotid ultrasonic variable that may have predictive capacity, alone or when integrated with conventional or non conventional risk factors, is the progression of carotid IMT. A prospective, multicenter, longitudinal, long term, observational study (The IMPROVE study) is currently ongoing. It aims to investigate the capacity of both cross sectional carotid IMT and overall IMT-progression to predict alone, or after integration with both conventional and non conventional VRF, the rate of new vascular events in an European population classifi ed at high risk of cardiovascular disease for the presence of at least 3 VRFs. The patients’ enrolment ended in April 2005 and a total of 3711 patients were recruited in 6 European countries.
Funding: Italian Ministry of Health, European Commission, IMPROVE projec
Common carotid artery diameter as a promising new candidate marker of cardiovascular risk in the IMPROVE study cohort
No full textAim: To explore whether inter-adventitial common carotid artery diameter (CCAD) detected by B-mode ultrasound may be considered a candidate marker of cardiovascular risk.
Methods: The baseline data of the IMPROVE study cohort, including 1776 men and 1935 women representative of an European population at high risk of cardiovascular diseases, were analysed to explore whether CCAD is associated with the extent of carotid atherosclerosis, independently of traditional vascular risk factors and anthropometric variables.
Results: After adjustment for possible confounders (height, centre, reader and sonographer), CCAD was positively associated with male gender, age, weight, body mass index, waist, hip, waist/hip ratio, systolic and diastolic blood pressure, pulse pressure, triglycerides, blood glucose, uric acid, cigarette packyears and family history of peripheral vascular disease (all p<0.0001). In contrast, years elapsed since smoking cessation, total-, HDL- and LDL-cholesterol were negatively related to CCAD (all p<0.0001). In the full model adjusted for all these confounders, CCAD was positively associated with carotid wall thickness (p<0.0001 for both IMTmean and IMTmax) and with the prevalence of carotid segments with plaques (p<0.04).
Conclusion: Inter-adventitial CCAD is positively associated with carotid atherosclerosis and with most vascular risk factors. These results suggest that CCAD is a promising candidate marker of cardiovascular risk. Completion of the IMPROVE study will allow to assess prospectively the value of CCAD to predict new vascular events, independently to VRFs and carotid IMT.
Funding: European Project, IMPROVE QLG1-CT-2002-0089
Common carotid artery diameter as a marker of cardiovascular risk: preliminary results of the improve study
No full textBackground: The “IMPROVE study” was designed to investigate whether cross-sectional carotid artery intima media thickness (IMT) and overall IMT progression are predictors of vascular events in European individuals at high cardiovascular risk.
Aim: To investigate whether C-IMT could be combined with inter-adventitial common carotid artery diameter (ICCAD) to improve the predictability of vascular events.
Methods: IMPROVE is a prospective, multicenter, longitudinal, observational study. 3711 subjects (median age 64.4 years; 48% men) with at least 3 vascular risk factors (VRFs) were recruited in 7 centers in Finland, France, Italy, the Netherlands and Sweden. Collected variables included clinical, biochemical, genetic, socio-economic, psychological, nutritional, and educational data, personal and family history of diseases, drug intake and physical activity. 3703 patients were monitored for a median (IQR) follow-up of 36.2 (35.8-37.4) months. 215 patients suffered a first vascular event with an incidence of 20/1000 person-years.
Results: In Cox proportional-hazards regression, C-IMTs were associated with vascular risk (combined end point) even after adjustment for VRFs (Ptrend <0.005 for all). ICCAD was associated with the risk of events independently of VRFs and C-IMTmax (HRadj for 1 SD increase: 1.26, 95% CI: 1.08-1.48, p=0.004). Results for cardio and cerebro-vascular events were in line with those observed with the combined end point. By ROC curves analysis, ICCAD alone has about the same predictive capacity of the best predictor among C-IMT variables (IMTmean). When combined, IMTmean and ICCAD provided a better predictive capacity than conventional VRFs (c-statistic = 0.653 vs. 0.639).
Figure 1: Association of IMTmean-max and ICCAD with the incidence vascular events.
The combination of IMTmean, ICCAD and VRFs further improved the total predictive capacity (c-statistic 0.669).
Conclusions: ICCAD and C-IMT are independent predictors of cardiovascular events in European high-risk patients and together they enhance the predictive capacity of VRFs
Low levels of IgM antibodies against phosphorylcholine (anti-PC)increase the risk of ischemic cardiovascular events among European men at high risk of cardiovascular events
No full textPurpose: IgM antibodies against phosphorylcholine (anti-PC) reduce the uptake of oxidized LDL and inhibit the effect of-inflammatory phospholipids, thereby exerting an atheroprotective effect. Prevoius studies have shown that low anti-PC serum levels increase the risk of cardiovascular (CV) events. The aim of the present study was to investigate the association of low levels of anti-PC with the incidence of CV events and the progression of intima media thickness (IMT) in a large cohort of individuals at high risk of cardiovascular diseases contained in the IMPROVE study, a prospective multicenter European study.
Methods: 3711 subjects (age 54-79) with at least three established cardiovascular risk factors at enrollment. Serum levels of anti-PC were measured at baseline on all the study participants by ELISA (CV Define, Athera Biotechnologies AB, Stockholm Sweden). Carotid ultrasound investigations were performed at baseline and after 15 and 30 months of follow-up. The risk of ischemic cardiovascular events and IMT progression associated with low anti-PC levels was tested by a Cox regression and a logistic regression analysis, respectively. Risk estimates were adjusted by center, gender, age and the conventional cardiovascular risk factors.
Results: 3516 were included in the present analysis and 198 incident ischemic cardiovascular events were recorded during a 3 year follow up. Anti-PC levels (U/ml) were classified into quartiles [Q1≤ 40, Q2 >40-≤64, Q3 >64-≤102, Q4 >102] and the highest quartile (Q4) was taken as reference. Presence of low levels (Q1 vs Q4) of anti-PC was associated with an increased risk of CV events in men with a multivariately adjusted HR of 1.76 and 95%CI (1.02-3.03). In men, low levels of anti-PC were found to be associated with the highest (> 90th) percentile of the fastest IMT progression, i.e. the segment showing the fastest progression over 30 months in the whole carotid tree, with an OR of 1.42 (95%CI:1.03-1.98). No significant associations were found in women.
Conclusions: These results suggest that low anti-PC serum levels increase the risk of cardiovascular events in men partly through effects on progression of atherosclerosis
The count of family histories of vascular diseases is an independent de-terminant of susbclinical atherosclerosis
No full textBACKGROUND: The individual cardiovascular risk increases with the numbers of relatives affected by cardiovascular (CV) diseases and with the genealogical proximity of relatives affected. These findings document the importance of genetic/environmental factors, nested in the family, for the development of atherosclerosis or cardiovascular diseases. Several FH items have been associated with an increased risk of CV disease, among these: FH of coronary heart disease (FHCHD), FH of cerebrovascular disease (FHCVD), and FH of peripheral vascular disease (FHPVD). Most of the studies published so far, however, were carried out by considering these FH items one at a time, completely neglecting that a single individuals may be simultaneously exposed to more than one FH items and that these may increase the individual atherosclerosis with an additive or even synergistic effects. In this study we have addressed this issue by investigating whether multiple FH items associates with carotid artery intima media thickness (C-IMT) independently by the personal presence of vascular risk factors and whether these items act with an additive/synergistic effect or not.
METHODS: To reach the study objective we have take advantage of the dataset of the IMPROVE project, a European, multicenter, longitudinal, observational study specifically designed to assess whether C-IMT and its change over time associate with vascular events (VEs). The data set includes 3711 individuals free of vascular events (median age 64.4 years; 48% men) followed up for three years. The subject’s FH profile was determined by a face-to-face interviews. The presence of at least one first-degree family member (father, mother, brothers or sisters) affected by CHD, CVD or PVD identified the patient as positive for a specific FH. The total count of FH items (FHcount) was calculated on individual basis.
RESULTS: The 21.5% of subjects were free of any family history of vascular diseases, the 50.8% was exposed to one FH item, the 23.8% to two, and the 3.9% to three. In a multivariable general linear model, adjusted for those vascular risk factors which may aggregate at the family level; (i.e. dyslipidemia, hypertension and diabetes), FHCHD, FHPVD but not FHCVD associated with a greater IMT value (both p<0.05) when compared to subjects free of any family history. Regardless of the type of FH item considered, the average value of IMTmean-max increased, step by step, of about 1.02% (95% C.I. 1.00-1.03), moving from subjects without any FH item, to subjects with one, two or three types of family history of vascular diseases (ptrend=0.003). This trend was confirmed also after adjustment for confounders and for the personal history of VRFs (ptrend=0.011), thus suggesting an independent and additive effect of the three FH items in determining the individual atherosclerotic profile.
CONCLUSIONS: Regardless the type of items included, the simple count of FH items, may be considered as a new risk factor for carotid IMT which adds over and above each single FH item
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