Clinical Trial: Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Heavy Metals (Cadmium, Lead, Mercury, Zinc), Angiogenesis Factors (Endostatin, Angiostatin, VEGF) and Osteopontin in Patients With Coronary Artery Disease

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 (AIHD:ICD-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 Summary:

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.

Measurement of cadmium, lead, mercury and zinc in patients with acute or chronic ischemic heart disease (AIHD, CIHD).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 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
  • 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 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
  • 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 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
  • 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 ]
    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


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: December 5, 2012
Date Started: September 2010
Date Completion:
Last Updated: June 6, 2014
Last Verified: June 2014