Improving Intermediate Risk Management. MARK Study
Recruitment status was Recruiting
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. The purpose of this study 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.
Peripheral Arterial Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Improving Intermediate Risk Management. MARK Study|
- Vascular events [ Time Frame: 10 years ] [ Designated as safety issue: No ]There will be a telephone follow-up at 10 years to verify the vital status and the existence of hospital admissions due to vascular health problems: Fatal and non fatal coronary heart disease (myocardial infarction or angina pectoris), stroke and peripheral arterial disease
Biospecimen Retention: Samples Without DNA
Blood sample: Cholesterol and triglycerides concentration, HDL cholesterol, LDL cholesterol, Glucose concentration, glycated hemoglobin and creatinine Urine sample:urine albumin, to calculate the albumin/creatinine index. Postprandial glucose (mg / dl) will be self-measured by patients at home 2 hours after meals (breakfast, lunch and dinner) for one day using an Accu-chek ® glucometer.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Intermediate risk population
Population aged between 35 to 74 years who have an intermediate cardiovascular risk, defined as coronary risk between 5% -15% at 10 years according to the Framingham adapted risk equation or vascular mortality risk between 3-5% at 10 years according to the SCORE equation .
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. However, specificity and sensitivity of risk equations are modest, which means that approximately 50% of the patients who are likely to develop a vascular event and would benefit from preventive measures are not considered at high risk. While 30% of the subjects considered at risk don't really benefit from preventive measures. Moreover, decisions which imply thousands of people and can determine drug treatment indications are taken every day in primary care centers. These decisions are based mostly on the result of estimations about the probability to develop a vascular disease in 10 years. Improvement of these predictions in our country will have an immediate, clinical and welfare impact and a short term public health effect.
The purpose of this study 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428934
|Contact: Rafel Ramos||+34 972 48 79 firstname.lastname@example.org|
|Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut||Recruiting|
|Girona, Spain, 17003|
|Contact: Rafel Ramos +34 972 48 79 68 email@example.com|
|Principal Investigator:||Rafel Ramos||Unidad de Invesitigación en Atención Primaria de Girona, IDIAP Jordi Gol. Instituto de Investigación Biomédica de Girona Dr. Josep Trueta (IDIBGI). Departamento de Ciencias Médicas, Universidad de Girona|