Antioxidants in the risk of cardiovascular disease

ISRCTN	ISRCTN12745004
DOI	https://doi.org/10.1186/ISRCTN12745004
Protocol serial number	1
Sponsor	Regional Hospital of Pardubice (Czech Republic)
Funder	Ministry of Education, Youth and Sports (Czech Republic) (ref: CR grant COST 926 OC 124; 0021627502)

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

University of Pardubice
Studentska 573
Pardubice
532 10
Czech Republic

Study information

Primary study design	Observational
Study design	Observational cross-sectional cohort study
Secondary study design	Cross-section survey
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(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)
Key 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
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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