Evaluation of Non-invasive Measurements of Atherosclerosis in Cardiovascular Risk Stratification (NIMA)
|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: NCT01555294|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Multiple risk factors contribute to atherosclerosis, which ultimately results in clinical manifestation of cardiovascular disease. Atherosclerosis results in both functional and morphological changes in the vessel wall, which can be measured by ultrasonography. The current study has been designed to
- To evaluate whether non-invasive measurements of atherosclerosis are independent predictors of cardiovascular disease and
- to delineate new biochemical parameters and genetic variations, allowing earlier and more effective preventive therapy
- The investigators intend to set guidelines for use of NIMA in an outpatient setting to facilitate early detection of increased cardiovascular risk and monitor life-style and pharmaceutical interventions.
In both the general population and in Familial Combined Hyperlipidemia.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1960 participants|
|Official Title:||Evaluation of Non-invasive Measurements of Atherosclerosis in Cardiovascular Risk Stratification: a Study in a Population-based Cohort and Familial Combined Hyperlipidemia|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
The present study is a substudy in the Nijmegen Biomedical Study (NBS). The NBS is a prospective population survey aimed at investigating the frequency of genetic variations in the general population. The study population is recruited as a sex- and age-stratified random sample of all inhabitants of Nijmegen 20 to 90 years old (n=10.000). Recruitment has started in october 2001.
In the current study 1517 participants aged 50-70 years were included from 2005 to 2008, from whom baseline characteristics were obtained. All visited our hospital and during the visit venous blood was drawn, height and weight were measured, a questionnaire about medical history, life style habits, and family history was completed and non-invasive measurements of atherosclerosis were performed.
Familial Combined Hyperlipidemia
FCH is the most common inherited dyslipidemia in man. Affected individuals are characterized by elevated cholesterol and/or triglyceride levels and an increased risk of CVD. Our data base contains a unique population of 40 well-characterized FCH families, including 687 patients, relatives and spouses. These families were recruited in 1994 and extensively studied, including information on an extensive panel of biochemical and genetic parameters. In total 343 participants were included in the NIMA study; 103 FCH patients and 240 unaffected relatives from whom baseline characteristics were obtained.
- Cardiovascular events [ Time Frame: 3-7 years ]Fatal and non-fatal cardiovascular events will be evaluated by questionnaire and validated using hospital records and records from general practitioners.
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): NCT01555294
|Radboud University Nijmegen Medical Centre, Department of General Internal Medicine, Division of Vascular Medicine|
|Principal Investigator:||Jacqueline de Graaf, MD, PhD||Radboud University Nijmegen Medical Centre, Dept. of General Internal Medicine, Division of Vascular Medicine|
|Study Chair:||Anton FH Stalenhoef, MD, PhD||Radboud University Nijmegen Medical Centre, Dept. of General Internal Medicine, Division of Vascular Medicine|
|Study Chair:||Martin den Heijer, MD, PhD||Radboud University Nijmegen Medical Centre, Dept. of Epidemiology and Biostatistics|
|Study Chair:||Suzanne Holewijn, PhD||Radboud University Nijmegen Medical Centre, Dept. of General Internal Medicine, Division of Vascular Medicine|