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| [ Print-friendly version ] |
| Antioxidants in the risk of cardiovascular disease |
| ISRCTN | ISRCTN12745004 |
| ClinicalTrials.gov identifier | |
| Public title | Antioxidants in the risk of cardiovascular disease |
| Scientific title | An observational cross-sectional cohort study of the protective role of antioxidants against oxidative stress and inflammation in patients with a risk of cardiovascular disease |
| Acronym | AOCARD |
| Serial number at source | 1 |
| Study hypothesis | There is a link between plasma concentrations of beta-carotene and alpha-tocopherol, the level of systemic inflammation and oxidative stress in patients with advanced coronary artery disease. Our presumption is that beta-carotene and alpha-tocopherol both hold protective roles against oxidative stress and inflammation. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Hospital Ethical Committee on Human Research of Regional Hospital of Pardubice, Czech Republic approved on the 12th May 2006 |
| Study design | Observational cross-sectional cohort study |
| Countries of recruitment | Czech Republic |
| Disease/condition/study domain | Coronary artery disease |
| Participants - inclusion criteria |
Participants were recruited from the Department of Cardiology, Regional Hospital of Pardubice.
Group 1: 1.1. Both males and females, aged 45 - 69 years 1.2. Patients with non-acute chest pain 1.3. Significant stenosis (coronary angiography) Group 2: 2.1. Both males and females, aged 45 - 69 years 2.2. Patients with non-acute chest pain 2.3. No stenosis (coronary angiography) |
| Participants - exclusion criteria |
1. Renal, hepatic or oncologic disease
2. Intake of vitamin and nutrition supplements |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 140 |
| Interventions |
Patients diagnosed with non-acute coronary angiography for chest pain will be entered into the study in one of two groups:
Group 1: significant stenosis of coronary arteries Group 2: patients without any stenosis Venous blood was obtained under standard conditions, from 7 to 8 am after fasting for at least 12 hours. For the determination of beta-carotene, alpha-tocopherol and malondialdehyde concentrations, blood was collected in tubes with ethylenediaminetetraacetic acid (EDTA) covered with aluminium foil to avoid carotenoid oxidation and polymerisation by oxygen and light. Plasma was obtained by centrifugation of the blood samples at 1500 g for 20 minutes and immediately stored at -80°C in 1.5 ml amber polypropylene tubes. A questionnaire was also provided for the evaluation of pharmacotherapy, intake of nutrition or vitamin supplements, smoking or other diseases such as hypertension or diabetes. |
| Primary outcome measure(s) |
Measured from standard venous blood collection (see interventions section):
1. Beta-carotene 2. Alpha-tocopherol 3. Malondialdehyde 4. Free radicals 5. High sensitivity c-reactive protein (hsCRP) 6. Interleukin-6 (IL-6) |
| Secondary outcome measure(s) |
Measured from standard venous blood collection (see interventions section):
1. High density lipoprotein (HDL)-cholesterol 2. Low density lipoprotein (LDL)-cholesterol 3. Triglycerides 4. Total cholesterol 5. Glucose 6. Fibrinogen 7. Ceruloplasmin 8. Albumin 9. Transferrin 10. Haemoglobin |
| Sources of funding | Ministry of Education, Youth and Sports (Czech Republic) (ref: CR grant COST 926 OC 124; 0021627502) |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21792817 |
| Contact name | Dr Vladimira Muzakova |
| Address |
University of Pardubice
Studentska 573 |
| City/town | Pardubice |
| Zip/Postcode | 532 10 |
| Country | Czech Republic |
| Sponsor | Regional Hospital of Pardubice (Czech Republic) |
| Address | Kyjevska 44 |
| City/town | Pardubice |
| Zip/Postcode | 530 02 |
| Country | Czech Republic |
| Sponsor website: | http://www.nemocnice-pardubice.cz/ |
| Date applied | 23/10/2009 |
| Last edited | 11/10/2011 |
| Date ISRCTN assigned | 19/11/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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