Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
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
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.
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
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Coronary artery disease
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/09/2008
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Renal, hepatic or oncologic disease
2. Intake of vitamin and nutrition supplements
Recruitment start date
01/09/2008
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Czech Republic
Trial participating centre
University of Pardubice
Pardubice
532 10
Czech Republic
Sponsor information
Organisation
Regional Hospital of Pardubice (Czech Republic)
Sponsor details
Kyjevska 44
Pardubice
530 02
Czech Republic
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Ministry of Education, Youth and Sports (Czech Republic) (ref: CR grant COST 926 OC 124; 0021627502)
Alternative name(s)
Ministry of Education, Youth and Sports, MŠMT
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Czech Republic
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21792817
Publication citations
-
Results
Muzáková V, Kand'ár R, Meloun M, Skalický J, Královec K, Záková P, Vojtísek P, Inverse correlation between plasma Beta-carotene and interleukin-6 in patients with advanced coronary artery disease., Int J Vitam Nutr Res, 2010, 80, 6, 369-377, doi: 10.1024/0300-9831/a000024.