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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Myocardial Infarction Angina Pectoris Stroke Peripheral Arterial Disease |
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 |
| Actual Enrollment : | 2495 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Improving Intermediate Risk Management. MARK Study |
| Study Start Date : | July 2011 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2016 |
| Group/Cohort |
|---|
|
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].
|
- 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
Biospecimen Retention: Samples Without DNA
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 35 Years to 74 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428934
| Spain | |
| Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut | |
| Girona, Spain, 17003 | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
| ClinicalTrials.gov Identifier: | NCT01428934 |
| Other Study ID Numbers: |
PI10/01088 |
| First Posted: | September 5, 2011 Key Record Dates |
| Last Update Posted: | March 9, 2018 |
| Last Verified: | September 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
Myocardial Infarction Peripheral Arterial Disease Peripheral Vascular Diseases Angina Pectoris Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Chest Pain Pain Neurologic Manifestations |