Improving interMediAte Risk management. MARK study

BMC Cardiovascular Disorders

Rafel Ramos⁴  Miquel Quesada⁴  Anna Ponjoan²  Maria Garcia-Gil⁴  Natalia Feuerbach¹  Cristina Agudo-Conde³  Jose I Recio-Rodriguez³  Natividad García-Regalado¹  Irene Sempere¹  Manuel A Gómez-Marcos³  Fernando Rigo¹  Luís García-Ortiz³  Dídac Parramon²  Ruth Martí² 

[1]CS San Agustín, Gerencia Atención Primaria Ibsalut, C/Nicolau Alemany 1, Palma de Mallorca, 07015, España

[2]Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Av. de França s/n, Girona, 17007, Espanya

[3]Unidad de Investigación de Atención Primaria La Alamedilla, Centro de Salud La Alamedilla, Av Comuneros 27-31, Salamanca, 37003, España

[4]Departament de Ciències Mèdiques. Facultat de Medicina Universitat de Girona, Campus de Montilivi, Girona, 17071, Espanya

关键词: primary health care.;    primary prevention;    cardiovascular diseases;    Risk assessment;   

Others  :  1085645
DOI  :  10.1186/1471-2261-11-61

 received in 2011-09-08, accepted in 2011-10-13,  发布年份 2011

【 摘 要 】

Background

Cardiovascular risk functions fail to identify more than 50% of patients who develop cardiovascular disease. This is especially evident in the intermediate-risk patients in which clinical management becomes difficult. Our purpose is to analyze if ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are independently associated to incidence of vascular events and whether they can improve the predictive capacity of current risk equations in the intermediate-risk population.

Methods/Design

This project involves 3 groups belonging to REDIAPP (RETICS RD06/0018) from 3 Spanish regions. We will recruit a multicenter cohort of 2688 patients at intermediate risk (coronary risk between 5 and 15% or vascular death risk between 3-5% over 10 years) and no history of atherosclerotic disease, selected at random. We will record socio-demographic data, information on diet, physical activity, comorbidity and intermittent claudication. We will measure ABI, pulse wave velocity and cardio ankle vascular index at rest and after a light intensity exercise. Blood pressure and anthropometric data will be also recorded. We will also quantify lipids, glucose and glycosylated hemoglobin in a fasting blood sample and postprandial capillary glucose. Eighteen months after the recruitment, patients will be followed up to determine the incidence of vascular events (later follow-ups are planned at 5 and 10 years). We will analyze whether the new proposed risk factors contribute to improve the risk functions based on classic risk factors.

Discussion

Primary prevention of cardiovascular diseases is a priority in public health policy of developed and developing countries. The fundamental strategy consists in identifying people in a high risk situation in which preventive measures are effective and efficient. Improvement of these predictions in our country will have an immediate, clinical and welfare impact and a short term public health effect.

Trial Registration

Clinical Trials.gov Identifier: NCT01428934

【 授权许可】

   
2011 Martí et al; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Mortality study in Spain. Instituto de Salud Carlos III (08/01/2010) [http://193.146.50.130/raziel.php] webcite
• [2]Marrugat J, Elosua R, Martí H: Epidemiology of ischaemic heart disease in Spain: estimation of the number of cases and trends from 1997 to 2005. Rev Esp Cardiol 2002, 55:337-346.
• [3]Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, Dallongeville J, De Backer G, Ebrahim S, Gjelsvik B, Herrmann-Lingen C, Hoes A, Humphries S, Knapton M, Perk J, Priori SG, Pyorala K, Reiner Z, Ruilope L, Sans-Menendez S, Scholte op Reimer W, Weissberg P, Wood D, Yarnell J, Zamorano JL, Walma E, Fitzgerald T, Cooney MT, Dudina A: European guidelines on cardiovascular disease prevention in clinical practice: executive summary: Fourth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (Constituted by representatives of nine societies and by invited experts). Eur Heart J 2007, 28:2375-414.
• [4]Marrugat J, Subirana I, Comín E, Cabezas C, Vila J, Elosua R, Nam BH, Ramos R, Sala J, Solanas P, Cordón F, Gené-Badia J, D'Agostino RB, VERIFICA Investigators: Validity of an adaptation of the Framingham cardiovascular risk function: the VERIFICA study. J Epidemiol Community Health 2007, 61:40-47.
• [5]Folsom AR, Chambless LE, Ballantyne CM, Coresh J, Heiss G, Wu KK, Boerwinkle E, Mosley TH Jr, Sorlie P, Diao G, Sharrett AR: An Assessment of Incremental Coronary Risk Prediction Using C-Reactive Protein and Other Novel Risk Markers. Arch Intern Med 2006, 166:1368-73.
• [6]Helfand M, Buckley DI, Freeman M, Fu R, Rogers K, Fleming C, Humphrey LL: Emerging risk factors for coronary heart disease: a summary of systematic reviews conducted for the U.S. Preventive Services Task Force. Ann Intern Med 2009, 151:496-507.
• [7]U.S. Preventive Services Task Force: Using nontraditional risk factors in coronary heart disease risk assessment: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2009, 151:474-482.
• [8]Morrow DA, de Lemos JA: Benchmarks for the assessment of novel cardiovascular biomarkers. Circulation 2007, 115:949-952.
• [9]Ankle Brachial Index Collaboration, Fowkes FG, Murray GD, Butcher I, Heald CL, Lee RJ, Chambless LE, Folsom AR, Hirsch AT, Dramaix M, deBacker G, Wautrecht JC, Kornitzer M, Newman AB, Cushman M, Sutton-Tyrrell K, Fowkes FG, Lee AJ, Price JF, d'Agostino RB, Murabito JM, Norman PE, Jamrozik K, Curb JD, Masaki KH, Rodríguez BL, Dekker JM, Bouter LM, Heine RJ, Nijpels G, Stehouwer CD, Ferrucci L, McDermott MM, Stoffers HE, Hooi JD, Knottnerus JA, Ogren M, Hedblad B, Witteman JC, Breteler MM, Hunink MG, Hofman A, Criqui MH, Langer RD, Fronek A, Hiatt WR, Hamman R, Resnick HE, Guralnik J, McDermott MM: Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. JAMA 2008, 300:197-208.
• [10]Diehm C, Allenberg JR, Pittrow D, Mahn M, Tepohl G, Haberl RL, Darius H, Burghaus I, Trampisch HJ, German Epidemiological Trial on Ankle Brachial Index Study Group: Mortality and vascular morbidity in older adults with asymptomatic versus symptomatic peripheral artery disease. Circulation 2009, 120:2053-2061.
• [11]Ramos R, Quesada M, Solanas P, Subirana I, Sala J, Vila J, Masiá R, Cerezo C, Elosua R, Grau M, Cordón F, Juvinyà D, Fitó M, Isabel Covas M, Clarà A, Angel Muñoz M, Marrugat J, REGICOR Investigators: Prevalence of symptomatic and asymptomatic peripheral arterial disease and the value of the ankle-brachial index to stratify cardiovascular risk. Eur J Vasc Endovasc Surg 2009, 38:305-311.
• [12]Vlachopoulos C, Aznaouridis K, Stefanadis C: Prediction of Cardiovascular Events and All-Cause Mortality With Arterial Stiffness A Systematic Review and Meta-Analysis. J Am Coll Cardiol 2010, 55:1318-1327.
• [13]Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clément D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, van Zwieten PA, Viigimaa M, Zanchetti A, European Society of Hypertension: Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens 2009, 27:2121-58.
• [14]Shirai K, Utino J, Otsuka K, Takata M: A novel blood pressure-independent arterial wall stiffness parameter; cardio-ankle vascular index (CAVI). J Atheroscler Thromb 2006, 13:101-107.
• [15]Takaki A, Ogawa H, Wakeyama T, Iwami T, Kimura M, Hadano Y, Matsuda S, Miyazaki Y, Hiratsuka A, Matsuzaki M: Cardio-ankle vascular index is superior to brachial-ankle pulse wave velocity as an index of arterial stiffness. Hypertens Res 2008, 31:1347-1355.
• [16]Selvin E, Marinopoulos S, Berkenblit G, Rami T, Brancati FL, Powe NR, Golden SH: Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med 2004, 141:421-431.
• [17]Adams RJ, Appleton SL, Hill CL, Wilson DH, Taylor AW, Chittleborough CR, Gill TK, Ruffin RE: Independent association of HbA(1c) and incident cardiovascular disease in people without diabetes. Obesity (Silver Spring) 2009, 17:559-563.
• [18]Selvin E, Zhu H, Brancati FL: Elevated A1C in Adults Without a History of Diabetes in the U.S. Diabetes Care 2009, 32:828-833.
• [19]Bonora E: Postprandial peaks as a risk factor for cardiovascular disease: epidemiological perspectives. Int J Clin Pract Suppl 2002, 129:5-11.
• [20]Peter R, Okoseime OE, Rees A, Owens DR: Postprandial glucose - a potential therapeutic target to reduce cardiovascular mortality. Curr Vasc Pharmacol 2009, 7:68-74.
• [21]Ohkubo T, Imai Y, Tsuji I, Nagai K, Kato J, Kikuchi N, Nishiyama A, Aihara A, Sekino M, Kikuya M, Ito S, Satoh H, Hisamichi S: Home blood pressure measurement has a stronger predictive power for mortality than does screening blood pressure measurement: a population-based observation in Ohasama, Japan. J Hypertens 1998, 16:971-975.
• [22]Soriano JB, Rigo F, Guerrero D, Yañez A, Forteza JF, Frontera G, Togores B, Agustí A: High prevalence of undiagnosed airflow limitation in patients with cardiovascular disease. Chest 2010, 137:333-40.
• [23]Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, Minhas R, Sheikh A, Brindle P: Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2. BMJ 2008, 336:1475-82.
• [24]Schulz R, Beach SR, Ives DG, Martire LM, Ariyo AA, Kop WJ: Association between depression and mortality in older adults: the Cardiovascular Health Study. Arch Intern Med 2000, 160:1761-8.
• [25]Sachdev M, Sun JL, Tsiatis AA, Nelson CL, Mark DB, Jollis JG: The prognostic importance of comorbidity for mortality in patients with stable coronary artery disease. J Am Coll Cardiol 2004, 43:576-82.
• [26]Marrugat J, D'Agostino R, Sullivan L, Elosua R, Wilson P, Ordovas J, Solanas P, Cordón F, Ramos R, Sala J, Masiá R, Kannel WB: An adaptation of the Framingham coronary heart disease risk function to European Mediterranean areas. J Epidemiol Community Health 2003, 57:634-638.
• [27]Conroya RM, Pyo"ra"la"b K, Fitzgeralda AP, Sansc S, Menottid A, De Backere G, De Bacquere D, Ducimetie'ref P, Jousilahtig P, Keilh U, Njølstadi I, Oganovj RG, Thomsenk T, Tunstall-Pedoel H, Tverdalm A, Wedeln H, Whincupo P, Wilhelmsenn L, Grahama* IM, on behalf of the SCORE project group: Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. European Heart Journal 2003, 24:987-1003.
• [28]Charlson ME, Pompei P, Ales KL, MacKenzie CR: A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987, 40:373-383.
• [29]Linn BS, Linn MW, Gurel L: Cumulative illness rating scale. J Am Geriatr Soc 1968, 16:622-626.
• [30]Schröder H, Covas MI, Marrugat J, Vila J, Pena A, Alcántara M, Masiá R: Use of a three-day estimated food record, a 72-hour recall and a food-frequency questionnaire for dietary assessment in a Mediterranean Spanish population. Clin Nutr 2001, 20:429-437.
• [31]Mártinez-González MA, Fernández-Jarne E, Serrano-Martínez M, Wright M, Gomez-Garcia E: Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet. Eur J Clin Nutr 2004, 58:1550-1552.
• [32]Elosua R, Marrugat J, Molina L, Pons S, Pujol E: Validation of the Minnesota Leisure Time Physical Activity Questionnaire in Spanish men. The MARATHOM investigators. Am J Epidemiol 1994, 139:1197-1209.
• [33]Leng GC, Fowkes FG: The Edinburgh Claudication Questionnaire: an improved version of the WHO/Rose Questionnaire for use in epidemiological surveys. J Clin Epidemiol 1992, 45:1101-1109.
• [34]Stergiu GS, Skeva II, Zourbaki AS, Mountokalakis TD: Self-monitoring of blood pressure at home: how many measurements are needed? J Hypertens 1998, 16:725-31.