The predictive value of repeated Non-Invasive Measurements of Atherosclerosis (NIMA) in relation to cardiovascular risk factors and cardiovascular disease stratification: a study in the general population and in Familial Combined Hyperlipidemia (NBS-NIMA 2)
Recruiting
- Conditions
- 10003216arteriosclerosisatherosclerosis1000751010013317
- Registration Number
- NL-OMON34376
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1900
Inclusion Criteria
Diagnosis of Familial Combined Hyperlipidemia (FCH) in the patient cohort and relatives.
In population-based cohort: age at time of inclusion in NIMA1: 50-70 years, part of Nijmegen Biomedical Study.
Exclusion Criteria
Age under 18 in FCH cohort.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objectives:<br /><br><br /><br>1. To unravel the impact of time and time of exposure to different CV risk<br /><br>factors on the development and progression of (subclinical)atherosclerosis, as<br /><br>measured by repeated NIMA, and CVD, as measured by clinical endpoints in both<br /><br>the general population and families with FCH.<br /><br>2. To develop an evidence-based protocol for NIMA to improve cardiovascular<br /><br>risk stratification for the individual patient in clinical practice.<br /><br>3. To determine which traditional and new clinical, biochemical and genetic CV<br /><br>risk factors are the main determinants of each of the NIMA (FMD, ABI at rest<br /><br>and after exercise, PWV, PWA parameters, IMT and presence and thickness of<br /><br>plaques in the carotid arteries)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives:<br /><br><br /><br>- Data on the short-term variability in NIMA will enable us to better determine<br /><br>the predictive value of NIMA.<br /><br>- To unravel differences in the development of subclinical atherosclerosis and<br /><br>CV events between men and women.<br /><br>- Identification of the combination of NIMA that will improve CV risk<br /><br>stratification in a low and a high-risk population in a cost-effective way,<br /><br>allowing earlier and more effective (new) preventive therapy in both the<br /><br>general population and families with FCH.<br /><br>- To evaluate the power of baseline versus repeated NIMA in CVD risk<br /><br>prediction, over and beyond CV risk factors in both the general population and<br /><br>families with FCH.</p><br>