Improving Intermediate Risk Management. MARK Study

Stroke Clinical Trial

— MARK  

Official title:

Improving Intermediate Risk Management. MARK Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428934
• Other study ID #: PI10/01088
• Status: Completed
• Phase: N/A
• First received: August 31, 2011
• Last updated: March 8, 2018
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2495
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Infarction
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stroke

Locations

Country	Name	City	State
Spain	Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut	Girona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

References & Publications (32)

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Takaki A, Ogawa H, Wakeyama T, Iwami T, Kimura M, Hadano Y, Matsuda S, Miyazaki Y, Hiratsuka A, Matsuzaki M. Cardio-ankle vascular index is superior to brachial-ankle pulse wave velocity as an index of arterial stiffness. Hypertens Res. 2008 Jul;31(7):1347-55. doi: 10.1291/hypres.31.1347. — View Citation

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular events	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	10 years

External Links

•   Mortality study in Spain. Instituto de Salud Carlos III (08/01/2010)