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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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