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
  Purpose

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.


Condition
Myocardial Infarction
Angina Pectoris
Stroke
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Intermediate Risk Management. MARK Study

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 2688
Study Start Date: July 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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].

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.

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428934

Contacts
Contact: Rafel Ramos +34 972 48 79 68 rramos.girona.ics@gencat.cat

Locations
Spain
Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut Recruiting
Girona, Spain, 17003
Contact: Rafel Ramos    +34 972 48 79 68    rramos.girona.ics@gencat.cat   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
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
  More Information

Additional Information:
Publications:
Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, Dallongeville J, De Backer G, Ebrahim S, Gjelsvik B, Herrmann-Lingen C, Hoes A, Humphries S, Knapton M, Perk J, Priori SG, Pyorala K, Reiner Z, Ruilope L, Sans-Menendez S, Scholte op Reimer W, Weissberg P, Wood D, Yarnell J, Zamorano JL, Walma E, Fitzgerald T, Cooney MT, Dudina A; European Society of Cardiology (ESC) Committee for Practice Guidelines (CPG). European guidelines on cardiovascular disease prevention in clinical practice: executive summary: Fourth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (Constituted by representatives of nine societies and by invited experts). Eur Heart J. 2007 Oct;28(19):2375-414. Epub 2007 Aug 28. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01428934     History of Changes
Other Study ID Numbers: PI10/01088
Study First Received: August 31, 2011
Last Updated: September 2, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Angina Pectoris
Infarction
Myocardial Infarction
Stroke
Peripheral Arterial Disease
Peripheral Vascular Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 27, 2014