CompletedPhase 2

Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

36 participantsStarted 2005-01

Plain-language summary

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * CAD or PAD (\>50% luminal stenosis), previous myocardial infarction or bypass surgery \>3 month ago * history of percutaneous coronary intervention (PTCA or stenting) * confirmed consent Exclusion Criteria: * myocardial infarction or acute coronary syndrome or bypass surgery \<3 month ago * ongoing treatment with statins * ongoing vitamin supplementation with folic acid and B vitamins * \<18 years * active smokers * uncontrolled arterial hypertension * renal insufficiency * atrial fibrillation * liver disease * NYHA class \>2 * familial hypercholesterolemia

What they're measuring

Flow mediated dilatation (FMD)

Timeframe: after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Trial details

NCT IDNCT00693589

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-02

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