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

University of Pardubice
Studentska 573
Pardubice
532 10
Czech Republic

Study information

Study designObservational cross-sectional cohort study
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typePrevention
Scientific titleAn 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 acronymAOCARD
Study objectivesThere 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) studiedCoronary artery disease
InterventionPatients 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 typeOther
Primary outcome measureMeasured 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 measuresMeasured 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 date01/09/2008
Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants140
Key inclusion criteriaParticipants 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 criteria1. Renal, hepatic or oncologic disease
2. Intake of vitamin and nutrition supplements
Date of first enrolment01/09/2008
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • Czech Republic

Study participating centre

University of Pardubice
Pardubice
532 10
Czech Republic

Sponsor information

Regional Hospital of Pardubice (Czech Republic)
Hospital/treatment centre

Kyjevska 44
Pardubice
530 02
Czech Republic

Website http://www.nemocnice-pardubice.cz/
ROR logo "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
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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