Overview

This trial is active, not recruiting.

Conditions myocardial infarction, angina pectoris, stroke, peripheral arterial disease
Sponsor Jordi Gol i Gurina Foundation
Collaborator Preventive Services and Health Promotion Research Network
Start date July 2011
End date December 2013
Trial size 2495 participants
Trial identifier NCT01428934, PI10/01088

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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].

Primary Outcomes

Measure
Vascular events
time frame: 10 years

Eligibility Criteria

Male or female participants from 35 years up to 74 years old.

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

Additional Information

Official title Improving Intermediate Risk Management. MARK Study
Principal investigator Rafel Ramos
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.