Improving Intermediate Risk Management. MARK Study (MARK)
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|ClinicalTrials.gov Identifier: NCT01428934|
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : March 9, 2018
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|Condition or disease|
|Myocardial Infarction Angina Pectoris Stroke Peripheral Arterial Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||2495 participants|
|Official Title:||Improving Intermediate Risk Management. MARK Study|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2016|
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 .
- Vascular events [ Time Frame: 10 years ]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
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|Ages Eligible for Study:||35 Years to 74 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- Population aged 35 to 74 which have an intermediate cardiovascular risk.
- Terminal illness or institutionalization at the appointment time
- Personal history of atherosclerotic disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428934
|Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut|
|Girona, Spain, 17003|
|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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina|
|Other Study ID Numbers:||
|First Posted:||September 5, 2011 Key Record Dates|
|Last Update Posted:||March 9, 2018|
|Last Verified:||September 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases