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Improving Intermediate Risk Management. MARK Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Jordi Gol i Gurina Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01428934
First received: August 31, 2011
Last updated: September 2, 2011
Last verified: September 2011

August 31, 2011
September 2, 2011
July 2011
January 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01428934 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Improving Intermediate Risk Management. MARK Study
Improving Intermediate Risk Management. MARK Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Probability Sample

Population aged 35 to 74 which have an intermediate cardiovascular risk.

  • Myocardial Infarction
  • Angina Pectoris
  • Stroke
  • Peripheral Arterial Disease
Not Provided
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 [27].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2688
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Population aged 35 to 74 which have an intermediate cardiovascular risk.

Exclusion Criteria:

  • Terminal illness or institutionalization at the appointment time
  • Personal history of atherosclerotic disease
Both
35 Years to 74 Years
Yes
Contact: Rafel Ramos +34 972 48 79 68 rramos.girona.ics@gencat.cat
Spain
 
NCT01428934
PI10/01088
Yes
Jordi Gol i Gurina Foundation
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
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
Jordi Gol i Gurina Foundation
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP