Condition category
Circulatory System
Date applied
23/10/2009
Date assigned
19/11/2009
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vladimira Muzakova

ORCID ID

Contact details

University of Pardubice
Studentska 573
Pardubice
532 10
Czech Republic

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

http://www.nemocnice-pardubice.cz/

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

  1. 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.

Additional files

Editorial Notes