Evaluation of Non-invasive Measurements of Atherosclerosis in Cardiovascular Risk Stratification (NIMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jacqueline de Graaf, Radboud University
ClinicalTrials.gov Identifier:
NCT01555294
First received: September 6, 2011
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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

  1. To evaluate whether non-invasive measurements of atherosclerosis are independent predictors of cardiovascular disease and
  2. to delineate new biochemical parameters and genetic variations, allowing earlier and more effective preventive therapy
  3. 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
Cardiovascular Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Non-invasive Measurements of Atherosclerosis in Cardiovascular Risk Stratification: a Study in a Population-based Cohort and Familial Combined Hyperlipidemia

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Cardiovascular events [ Time Frame: 3-7 years ] [ Designated as safety issue: No ]
    Fatal and non-fatal cardiovascular events will be evaluated by questionnaire and validated using hospital records and records from general practitioners.


Enrollment: 1960
Study Start Date: May 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
community-based cohort

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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants recruited from a population-based survey aged 50-70 years. Participants from families with Familial Combined Hyperlipidemia.

Criteria

Population-based cohort:

Inclusion Criteria:

  • aged 50-70 years at inclusion

Exclusion Criteria:

  • recent symptomatic CV disease (<6 months)

Familial Combined Hyperlipidemia:

Inclusion Criteria:

  • age >18 years

Exclusion Criteria:

  • pregnancy
  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: NCT01555294

Locations
Netherlands
Radboud University Nijmegen Medical Centre, Department of General Internal Medicine, Division of Vascular Medicine
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
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
  More Information

Publications:
Murabito JM, White CC, Kavousi M, Sun YV, Feitosa MF, Nambi V, Lamina C, Schillert A, Coassin S, Bis JC, Broer L, Crawford DC, Franceschini N, Frikke-Schmidt R, Haun M, Holewijn S, Huffman JE, Hwang SJ, Kiechl S, Kollerits B, Montasser ME, Nolte IM, Rudock ME, Senft A, Teumer A, van der Harst P, Vitart V, Waite LL, Wood AR, Wassel CL, Absher DM, Allison MA, Amin N, Arnold A, Asselbergs FW, Aulchenko Y, Bandinelli S, Barbalic M, Boban M, Brown-Gentry K, Couper DJ, Criqui MH, Dehghan A, den Heijer M, Dieplinger B, Ding J, Dörr M, Espinola-Klein C, Felix SB, Ferrucci L, Folsom AR, Fraedrich G, Gibson Q, Goodloe R, Gunjaca G, Haltmayer M, Heiss G, Hofman A, Kieback A, Kiemeney LA, Kolcic I, Kullo IJ, Kritchevsky SB, Lackner KJ, Li X, Lieb W, Lohman K, Meisinger C, Melzer D, Mohler ER 3rd, Mudnic I, Mueller T, Navis G, Oberhollenzer F, Olin JW, O'Connell J, O'Donnell CJ, Palmas W, Penninx BW, Petersmann A, Polasek O, Psaty BM, Rantner B, Rice K, Rivadeneira F, Rotter JI, Seldenrijk A, Stadler M, Summerer M, Tanaka T, Tybjaerg-Hansen A, Uitterlinden AG, van Gilst WH, Vermeulen SH, Wild SH, Wild PS, Willeit J, Zeller T, Zemunik T, Zgaga L, Assimes TL, Blankenberg S, Boerwinkle E, Campbell H, Cooke JP, de Graaf J, Herrington D, Kardia SL, Mitchell BD, Murray A, Münzel T, Newman AB, Oostra BA, Rudan I, Shuldiner AR, Snieder H, van Duijn CM, Völker U, Wright AF, Wichmann HE, Wilson JF, Witteman JC, Liu Y, Hayward C, Borecki IB, Ziegler A, North KE, Cupples LA, Kronenberg F. Association between chromosome 9p21 variants and the ankle-brachial index identified by a meta-analysis of 21 genome-wide association studies. Circ Cardiovasc Genet. 2012 Feb 1;5(1):100-12. doi: 10.1161/CIRCGENETICS.111.961292. Epub 2011 Dec 23.
Gretarsdottir S, Baas AF, Thorleifsson G, Holm H, den Heijer M, de Vries JP, Kranendonk SE, Zeebregts CJ, van Sterkenburg SM, Geelkerken RH, van Rij AM, Williams MJ, Boll AP, Kostic JP, Jonasdottir A, Jonasdottir A, Walters GB, Masson G, Sulem P, Saemundsdottir J, Mouy M, Magnusson KP, Tromp G, Elmore JR, Sakalihasan N, Limet R, Defraigne JO, Ferrell RE, Ronkainen A, Ruigrok YM, Wijmenga C, Grobbee DE, Shah SH, Granger CB, Quyyumi AA, Vaccarino V, Patel RS, Zafari AM, Levey AI, Austin H, Girelli D, Pignatti PF, Olivieri O, Martinelli N, Malerba G, Trabetti E, Becker LC, Becker DM, Reilly MP, Rader DJ, Mueller T, Dieplinger B, Haltmayer M, Urbonavicius S, Lindblad B, Gottsäter A, Gaetani E, Pola R, Wells P, Rodger M, Forgie M, Langlois N, Corral J, Vicente V, Fontcuberta J, España F, Grarup N, Jørgensen T, Witte DR, Hansen T, Pedersen O, Aben KK, de Graaf J, Holewijn S, Folkersen L, Franco-Cereceda A, Eriksson P, Collier DA, Stefansson H, Steinthorsdottir V, Rafnar T, Valdimarsson EM, Magnadottir HB, Sveinbjornsdottir S, Olafsson I, Magnusson MK, Palmason R, Haraldsdottir V, Andersen K, Onundarson PT, Thorgeirsson G, Kiemeney LA, Powell JT, Carey DJ, Kuivaniemi H, Lindholt JS, Jones GT, Kong A, Blankensteijn JD, Matthiasson SE, Thorsteinsdottir U, Stefansson K. Genome-wide association study identifies a sequence variant within the DAB2IP gene conferring susceptibility to abdominal aortic aneurysm. Nat Genet. 2010 Aug;42(8):692-7. doi: 10.1038/ng.622. Epub 2010 Jul 11.

Responsible Party: Jacqueline de Graaf, Prof. Dr. J. de Graaf, Radboud University
ClinicalTrials.gov Identifier: NCT01555294     History of Changes
Other Study ID Numbers: CMO 2003/174
Study First Received: September 6, 2011
Last Updated: March 14, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
(subclinical)atherosclerosis
non-invasive measurements
intima-media thickness
flow-mediated dilation
pulse wave velocity and analysis
fatal and non-fatal cardiovascular events
ankle-brachial index (at rest and after exercise)
general population
Familial Combined Hyperlipidemia

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Hyperlipidemias
Hyperlipidemia, Familial Combined
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 22, 2014