Ignite Creation Date:
2024-05-06 @ 2:53 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02159235
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2012-12-05
Brief Title:
Heavy Metals Angiogenesis Factors and Osteopontin in Coronary Artery Disease CAD
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Heavy Metals Cadmium Lead Mercury Zinc Angiogenesis Factors Endostatin Angiostatin VEGF and Osteopontin in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 AIHDICD-10 I21 CIHD ICD-10 I25
3 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
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 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 AIHDICD-10 I21 CIHD ICD-10 I25
3 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 andor 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 proximalmedialdistal LAD lad left anterior descending artery ramus circumflex first and second marginal branch posterolateral branch first and second diagonal branch proximalmedialdistal LCX lcx left circumflex artery proximalmedialdistal 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 insufficiencystenosiscalcification 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 05 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 detectionquantification limits were 0402 μgl Pb 0067013 μgl Hg and 012040 μgl Cd In case the quantification limit was undercut the following expected amounts were used Cd 03 μgl Pb 1 μgl Hg 01 μgl 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 definedquantified as non physical activity walking less 3hweek walking more than 3 hoursweek sports less than 3 hoursweek and sports more than 3 hoursweek
Statistical analysis was done with SPSS 200 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 Pearsons 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 Spearmans 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 005 were considered significant The protocol was approved by the Ethical Commission of the Medical University of Vienna and informed consent was obtained from patients
Echocardiography was performed to evaluate left and right ventricular function multiple cross-sectional views valve insufficiencystenosiscalcification 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 05 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 detectionquantification limits were 0402 μgl Pb 0067013 μgl Hg and 012040 μgl Cd In case the quantification limit was undercut the following expected amounts were used Cd 03 μgl Pb 1 μgl Hg 01 μgl 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 definedquantified as non physical activity walking less 3hweek walking more than 3 hoursweek sports less than 3 hoursweek and sports more than 3 hoursweek
Statistical analysis was done with SPSS 200 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 Pearsons 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 Spearmans 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 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None