Antioxidants in the risk of cardiovascular disease
| ISRCTN | ISRCTN12745004 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12745004 |
| Secondary identifying numbers | 1 |
- Submission date
- 23/10/2009
- Registration date
- 19/11/2009
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Vladimira Muzakova
Scientific
Scientific
University of Pardubice
Studentska 573
Pardubice
532 10
Czech Republic
Study information
| Study design | Observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Study acronym | AOCARD |
| Study objectives | 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(s) | Hospital Ethical Committee on Human Research of Regional Hospital of Pardubice, Czech Republic approved on the 12th May 2006 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2008 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Key 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) |
| Key exclusion criteria | 1. Renal, hepatic or oncologic disease 2. Intake of vitamin and nutrition supplements |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
University of Pardubice
Pardubice
532 10
Czech Republic
532 10
Czech Republic
Sponsor information
Regional Hospital of Pardubice (Czech Republic)
Hospital/treatment centre
Hospital/treatment centre
Kyjevska 44
Pardubice
530 02
Czech Republic
| Website | http://www.nemocnice-pardubice.cz/ |
|---|---|
"ROR" |
https://ror.org/01a5ke137 |
Funders
Funder type
Government
Ministry of Education, Youth and Sports (Czech Republic) (ref: CR grant COST 926 OC 124; 0021627502)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- The Ministry of Education, Youth and Sports, MŠMT, MŠMT, MEYS
- Location
- Czech Republic
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2010 | Yes | No |
