Ischemic Heart DiseaseNCT02159235
Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)
An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The present study aims is to investigate: 1. whether patients suffering from acute resp. chronic ischemic heart disease show higher levels for cadmium (Cd), lead (Pb) and mercury (Hg) than local and international reference levels suggest; 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Disease, Heavy Metal Toxicity
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population will be recruited during their in-patient stay at the General Hospital of Vienna
Who may be able to join
- patients suffering ICD-10 I21 or I25, age 18-80, female and male, non-smokers or ex-smokers for at least 7 years
Who cannot join
- no ICD-10 I21 or I25, patients younger that 18 or older than 80, smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heavy Metals (Cadmium, Lead, Mercury, Zinc), Angiogenesis Factors (Endostatin, Angiostatin, VEGF) and Osteopontin in Patients With Coronary Artery Disease
The present study aims is to investigate:
- whether patients suffering from acute resp. chronic ischemic heart disease show higher levels for cadmium (Cd), lead (Pb) and mercury (Hg) than local and international reference levels suggest;
- the correlation between severity of coronary artery disease and angiogenic and angiostatic factors (endostatin-ES, angiostatin-AS, VEGF-vascular endothelial growth factor, osteopontin-OPN) The patient population consists of about 270 female and male patients suffering either acute or chronic ischemic heart disease (AIHD:ICD-10 I21; CIHD: ICD-10 I25).
- whether patients suffering CAD and valve calcification (mitral annulus, aortic valve) show higher levels of endostatin, angiostatin, osteopontin and VEGF compared to patients with CAD but without valve (annulus) calcification The measurement of cadmium (urine), lead, mercury, zinc, endostatin, angiostatin, VEGF (serum) and osteopontin (plasma) in patients with angiographically verified coronary artery disease are in the fore. Furthermore, basic laboratory diagnostics as well as data from coronary angiography and echocardiography will be collected. Additionally, the investigators will inquire heavy metal exposition during life by an interview.
Recruitment will be done during the in-patient stay at the General Hospital of Vienna, Medical University of Vienna.
Read the detailed description
Patients with angiographically verified CAD of different severity were recruited at the Department of Cardiology, Medical University of Vienna. Detailed anamnestic and clinical data was collected incl. cardiovascular risk factor assessment, medication, ECG (electrocardiogram), routine laboratory parameters, echocardiography and all patients underwent an coronary angiography for diagnostic and/or therapeutic reasons on grounds of their underlying disease. The coronary artery system was divided into 17 segments and stenosis grade for each segment was measured. The segments were: left main, proximal/medial/distal LAD (lad left anterior descending artery), ramus circumflex, first and second marginal branch, posterolateral branch, first and second diagonal branch, proximal/medial/distal LCX (lcx left circumflex artery), proximal/medial/distal RCA (right coronary artery), ramus interventricular posterior and stenosis grade for each segment was measured. A simple 3-point-grading system ("Coronary Score") was developed considering both frequency and severity of CAD: 0 points for non-stenosed or only calcified segments, 1 point for each stenosis from <30-<50 %, 2 points for each stenosis from 50-<70 % and 3 points for each stenosis >70 %. Blood samples for determination of ES, AS and VEGF levels were taken at least two days before or after an acute event (angina pectoris, STEMI-ST-elevation myocardial infarction, NSTEM-Non ST-elevation myocardial infarction) or an invasive intervention (angiography). ES, AS and VEGF were analysed in serum, OPN in plasma by ELISA-Enzyme Linked Immunosorbent Assay according to the instructions of the manufacturer.
Echocardiography was performed to evaluate left and right ventricular function (multiple cross-sectional views), valve insufficiency/stenosis/calcification and wall movement disorders.
Hg and Pb levels were measured in full-blood, Cd in urine. The outcrop of full-blood samples for the determination of Pb and Hg was done by 2 ml ultrapure water and 2 ml nitric acid (68% sub-boiled). The sample aliquot was 0,5 ml, backfilling volume 20 ml. The determination of Pb and Cd was performed by ICPMS (inductively coupled plasma mass spectrometry) according to the ÖNORM EN ISO 17294-2. The determination of Hg was done by AFS (atomic fluorescence spectroscopy) according to the ÖNORM EN 17852. The outcrop of urine samples for the determination of Cd was done by 2 ml ultrapure water and 2 ml nitric acid (68% sub-boiled). The sample aliquot was 5 ml, backfilling volume 20 ml. The detection/quantification limits were 0,40/2 μg/l (Pb), 0,067/0,13 μg/l (Hg) and 0,12/0,40 μg/l (Cd). In case the quantification limit was undercut, the following expected amounts were used: Cd: 0,3 μg/l, Pb: 1 μg/l, Hg: 0,1 μg/l. In case of Cd and Hg Human-Biomonitoring (HBM)-I and II levels and in case of Pb reference levels from the German Environmental Agency.
Physical activity of the patients was defined/quantified as non physical activity, walking less 3h/week, walking more than 3 hours/week, sports less than 3 hours/week and sports more than 3 hours/week.
Statistical analysis was done with SPSS 20.0. Continuous and normally distributed data is described by means ± standard deviation (SD) and group differences are tested by independent sample t-test and correlation were calculated using Pearson's correlation coefficient. Continuous data with skew distribution or outliers is described ny median, first and third quartile and minimum and maximum. Group differences are tested by Mann-Whitney-U-test and correlations were calculated using Spearman's correlation coefficient. For data with values below the quantification limit a value below quantification limit was imputed (the same value for all these observations) and the non-parametric Mann-Whitney-U-test was used. All tests are performed two-sided and p-values ≤ 0,05 were considered significant. The protocol was approved by the Ethical Commission of the Medical University of Vienna and informed consent was obtained from patients.
- Keywords
- cadmium, lead, mercury, zinc, endostatin, angiostatin, VEGF, CAD, osteopontin
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Heavy Metal Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AIHD-patients (ICD-10 I21) | Patients suffering from acute ischemic heart disease according to ICD-10 I21 | |
| CIHD-patients (ICD-10 I25) | patients suffering from chronic ischemic heart disease according to ICD-10 I25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
metal levels
Measurement of cadmium, lead, mercury and zinc in patients with acute or chronic ischemic heart disease (AIHD, CIHD).
Measured: 3 years
Secondary outcomes (4)
Correlation of endostatin-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Correlation of endostatin with severity of CAD (defined as described elsewhere) Correlation of endostatin with valve (annulus) calcification Correlation of endostatin with the grade of physical inactivity
Measured: 3 years
Correlation of angiostatin levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Correlation of angiostatin with severity of CAD (defined as described elsewhere) Correlation of angiostatin with valve (annulus) calcification Correlation of angiostatin with the grade of physical inactivity
Measured: 3 years
Correlation of osteopontin-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Correlation of osteopontin with severity of CAD (defined as described elsewhere) Correlation of osteopontin with valve (annulus) calcification Correlation of osteopontin with the grade of physical inactivity
Measured: 3 years
Correlation of VEGF-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Correlation of VEGF with severity of CAD (defined as described elsewhere) Correlation of VEGF with valve (annulus) calcification Correlation of VEGF with the grade of physical inactivity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanette Strametz-Juranek, Medical University of Vienna
- Investigators
- Jeanette Strametz-Juranek, Univ.Prof.Dr, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159235
- Sponsor's protocol ID
- EK2010/910
- Status last verified
- Jun 2014
- First submitted
- 5 Dec 2012
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heavy Metals (Cadmium, Lead, Mercury, Zinc), Angiogenesis Factors (Endostatin, Angiostatin, VEGF) and Osteopontin in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02159235
- Acronym / sponsor ID
- EK2010/910
- Keywords
- cadmium, lead, mercury, zinc, endostatin, angiostatin, VEGF, CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims is to investigate:
- whether patients suffering from acute resp. chronic ischemic heart disease show higher levels for cadmium (Cd), lead (Pb) and mercury (Hg) than local and international reference levels suggest;
- the correlation between severity of coronary artery disease and angiogenic and angiostatic factors (endostatin-ES, angiostatin-AS, VEGF-vascular endothelial growth factor, osteopontin-OPN) The patient population consists of about 270 female and male patients suffering either acute or chronic ischemic heart disease (AIHD:ICD-10 I21; CIHD: ICD-10 I25).
- whether patients suffering CAD and valve calcification (mitral annulus, aortic valve) show higher levels of endostatin, angiostatin, osteopontin and VEGF compared to patients with CAD but without valve (annulus) calcification The measurement of cadmium (urine), lead, mercury, zinc, endostatin, angiostatin, VEGF (serum) and osteopontin (plasma) in patients with angiographically verified coronary artery disease are in the fore. Furthermore, basic laboratory diagnostics as well as data from coronary angiography and echocardiography will be collected. Additionally, the investigators will inquire heavy metal exposition during life by an interview.
Recruitment will be done during the in-patient stay at the General Hospital of Vienna, Medical University of Vienna.
Detailed description
Patients with angiographically verified CAD of different severity were recruited at the Department of Cardiology, Medical University of Vienna. Detailed anamnestic and clinical data was collected incl. cardiovascular risk factor assessment, medication, ECG (electrocardiogram), routine laboratory parameters, echocardiography and all patients underwent an coronary angiography for diagnostic and/or therapeutic reasons on grounds of their underlying disease. The coronary artery system was divided into 17 segments and stenosis grade for each segment was measured. The segments were: left main, proximal/medial/distal LAD (lad left anterior descending artery), ramus circumflex, first and second marginal branch, posterolateral branch, first and second diagonal branch, proximal/medial/distal LCX (lcx left circumflex artery), proximal/medial/distal RCA (right coronary artery), ramus interventricular posterior and stenosis grade for each segment was measured. A simple 3-point-grading system ("Coronary Score") was developed considering both frequency and severity of CAD: 0 points for non-stenosed or only calcified segments, 1 point for each stenosis from <30-<50 %, 2 points for each stenosis from 50-<70 % and 3 points for each stenosis >70 %. Blood samples for determination of ES, AS and VEGF levels were taken at least two days before or after an acute event (angina pectoris, STEMI-ST-elevation myocardial infarction, NSTEM-Non ST-elevation myocardial infarction) or an invasive intervention (angiography). ES, AS and VEGF were analysed in serum, OPN in plasma by ELISA-Enzyme Linked Immunosorbent Assay according to the instructions of the manufacturer.
Echocardiography was performed to evaluate left and right ventricular function (multiple cross-sectional views), valve insufficiency/stenosis/calcification and wall movement disorders.
Hg and Pb levels were measured in full-blood, Cd in urine. The outcrop of full-blood samples for the determination of Pb and Hg was done by 2 ml ultrapure water and 2 ml nitric acid (68% sub-boiled). The sample aliquot was 0,5 ml, backfilling volume 20 ml. The determination of Pb and Cd was performed by ICPMS (inductively coupled plasma mass spectrometry) according to the ÖNORM EN ISO 17294-2. The determination of Hg was done by AFS (atomic fluorescence spectroscopy) according to the ÖNORM EN 17852. The outcrop of urine samples for the determination of Cd was done by 2 ml ultrapure water and 2 ml nitric acid (68% sub-boiled). The sample aliquot was 5 ml, backfilling volume 20 ml. The detection/quantification limits were 0,40/2 μg/l (Pb), 0,067/0,13 μg/l (Hg) and 0,12/0,40 μg/l (Cd). In case the quantification limit was undercut, the following expected amounts were used: Cd: 0,3 μg/l, Pb: 1 μg/l, Hg: 0,1 μg/l. In case of Cd and Hg Human-Biomonitoring (HBM)-I and II levels and in case of Pb reference levels from the German Environmental Agency.
Physical activity of the patients was defined/quantified as non physical activity, walking less 3h/week, walking more than 3 hours/week, sports less than 3 hours/week and sports more than 3 hours/week.
Statistical analysis was done with SPSS 20.0. Continuous and normally distributed data is described by means ± standard deviation (SD) and group differences are tested by independent sample t-test and correlation were calculated using Pearson's correlation coefficient. Continuous data with skew distribution or outliers is described ny median, first and third quartile and minimum and maximum. Group differences are tested by Mann-Whitney-U-test and correlations were calculated using Spearman's correlation coefficient. For data with values below the quantification limit a value below quantification limit was imputed (the same value for all these observations) and the non-parametric Mann-Whitney-U-test was used. All tests are performed two-sided and p-values ≤ 0,05 were considered significant. The protocol was approved by the Ethical Commission of the Medical University of Vienna and informed consent was obtained from patients.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIHD-patients (ICD-10 I21) | – | –Patients suffering from acute ischemic heart disease according to ICD-10 I21 |
| CIHD-patients (ICD-10 I25) | – | –patients suffering from chronic ischemic heart disease according to ICD-10 I25 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be recruited during their in-patient stay at the General Hospital of Vienna
Key inclusion criteria (1 listed)
- patients suffering ICD-10 I21 or I25, age 18-80, female and male, non-smokers or ex-smokers for at least 7 years
Key exclusion criteria (1 listed)
- no ICD-10 I21 or I25, patients younger that 18 or older than 80, smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
metal levels
Time frame: 3 years
Measurement of cadmium, lead, mercury and zinc in patients with acute or chronic ischemic heart disease (AIHD, CIHD).
4 secondary outcomes
Correlation of endostatin-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Time frame: 3 years
Correlation of angiostatin levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Time frame: 3 years
Correlation of osteopontin-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Time frame: 3 years
Correlation of VEGF-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanette Strametz-Juranek, Univ.Prof.Dr principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metal levels (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.