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Improving Intermediate Risk Management. MARK Study (MARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01428934
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Tracking Information
First Submitted Date August 31, 2011
First Posted Date September 5, 2011
Last Update Posted Date March 9, 2018
Study Start Date July 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2011)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Improving Intermediate Risk Management. MARK Study
Official Title Improving Intermediate Risk Management. MARK Study
Brief Summary 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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
Sampling Method Probability Sample
Study Population Population aged 35 to 74 which have an intermediate cardiovascular risk.
Condition
  • Myocardial Infarction
  • Angina Pectoris
  • Stroke
  • Peripheral Arterial Disease
Intervention Not Provided
Study Groups/Cohorts 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].
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2016)
2495
Original Estimated Enrollment
 (submitted: September 2, 2011)
2688
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01428934
Other Study ID Numbers PI10/01088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jordi Gol i Gurina Foundation
Study Sponsor Jordi Gol i Gurina Foundation
Collaborators Preventive Services and Health Promotion Research Network
Investigators
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
PRS Account Jordi Gol i Gurina Foundation
Verification Date September 2016