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Open Access Study protocol

Improving interMediAte Risk management. MARK study

Ruth Martí12, Dídac Parramon12, Luís García-Ortiz3, Fernando Rigo4, Manuel A Gómez-Marcos3, Irene Sempere4, Natividad García-Regalado4, Jose I Recio-Rodriguez3, Cristina Agudo-Conde3, Natalia Feuerbach4, Maria Garcia-Gil15, Anna Ponjoan12, Miquel Quesada125 and Rafel Ramos125*

Author Affiliations

1 Unitat d'Investigació en Atenció Primària de Girona, IDIAP Jordi Gol, Institut Català de la Salut, C/Maluquer Salvador, 11, Girona, 17071, Espanya

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

5 Departament de Ciències Mèdiques. Facultat de Medicina Universitat de Girona, Campus de Montilivi, Girona, 17071, Espanya

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BMC Cardiovascular Disorders 2011, 11:61  doi:10.1186/1471-2261-11-61

Published: 13 October 2011

Abstract

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

Keywords:
Risk assessment; cardiovascular diseases; primary prevention; primary health care.