The role of hyperhomocysteinemia in the genesis of atherothrombotic vascular disease

• Conditions: Established cardiovascular disease with elevated levels of homocystein

• Registration Number: EUCTR2004-003703-21-HU
• Lead Sponsor: Semmelweis University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1./ age between 18-75 years.
2./ coronary heart disease (myocardial infarct in anamnesis, positive coronarography), or defined peripheral obliterative arterial disease by Doppler sonography, or carotid artery disease by color duplex ultrasonography.
3./ hyperhomocysteinemia.
4./ signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1./ known hypersensitivity to folic acid or ascorbic acid
2./ disabled
3./ gravidity or lactation
4./ elevated liver function (3x)
5./ atrial fibrillation, extrasystolia
6./ undefined megaloblastic anemia
7./ known malignancy
8./ known nephrolithiasis
9./ situation that results the change in stabil medical treatment
10./ nitrate treatment
11./ diabetes mellitus
12./ cholesterin level higher than 6.5 mmol/l

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified