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Glycocalyx measurements in people with premature cardiovascular disease.

Non-invasive glycocalyx measurements in premature atherosclerosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25534
Enrollment
40
Registered
2009-02-03
Start date
2009-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis is currently the leading cause of death and disability in the developed world, often causing myocardial and cerebral infarction, kidney failure and peripheral arterial occlusive disease. Atherosclerosis is considered to be a chronic inflammatory response of the arterial wall, initiated by injury of the endothelium. The cause of this injury is unknown, but several factors, like hyperlipidemia, hypertension, smoking, toxins and viruses, have been indicated to play a role in its pat

Interventions

We will measure glycocalyx volumes with sublingual OPS imaging before and after NTG administration.

Sponsors

University of Maastricht, research institute CARIM
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases: Male and female. Subjects should have premature cardiovascular disease, which will be defined as cardiac, cerebral or peripheral vascular disease before the age of 40 years. Since a diminished glycocalyx volume is viewed as one of the first vascular alterations before overt atherosclerosis develops, we believe it is of no concern when the cardiovascular event had occurred. Furthermore, all of these subjects must have a positive family history for cardiovascular disease. This will be defined as at least one first degree or two or more second degree family members with cardiovascular disease before the age of 55 for men and before the age of 60 for women. Controls: Controls will be defined as healthy in case they have no cardiovascular history, such as no cardiac, cerebrovascular or peripheral artery disease and no complaints of angina, claudication or TIA and no family history for cardiovascular disease. Furthermore, they should be between the age of 35 and 55 years old.

Exclusion criteria

Exclusion criteria: Cases: Patients will be excluded if they have a positive history for hypertension, diabetes mellitus or other disease and in case of pregnancy or lactating women, if subjects are below the age of 18 years, or if subjects are unable to give informed consent. Controls: Controls will be excluded if they have had a myocardial infarction, CABG, PTCA, stroke, TIA or peripheral occlusive disease or complaints referring to one of these. They are also excluded if they have a positive family history for cardiovascular disease. Furthermore, they should not have a history of diabetes, hypertension, hypercholesterolemia or other disease. Besides subjects will be excluded in case of pregnancy or lactating women, if subjects are below the age of 18 years, or if subjects are unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
The volume of the intravascular glycocalyx, before and after NTG administration, in subjects with premature atherosclerosis before the age of 40 years as compared to healthy control subjects.

Secondary

MeasureTime frame
No secondary outcomes.

Contacts

Public ContactH. Vink
h.vink@fys.unimaas.nl+31 (0)43-3881233

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)