NCT02159235

Brief Summary

The present study aims is to investigate:

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
Last Updated

June 9, 2014

Status Verified

June 1, 2014

Enrollment Period

2.5 years

First QC Date

December 5, 2012

Last Update Submit

June 6, 2014

Conditions

Ischemic Heart DiseaseCoronary Artery DiseaseHeavy Metal Toxicity

Keywords

cadmiumleadmercuryzincendostatinangiostatinVEGFCADosteopontin

Outcome Measures

Primary Outcomes (1)

  • metal levels

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

    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)

    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)

    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)

    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)

    3 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population will be recruited during their in-patient stay at the General Hospital of Vienna

You may qualify if:

  • patients suffering ICD-10 I21 or I25, age 18-80, female and male, non-smokers or ex-smokers for at least 7 years

You may not qualify if:

  • no ICD-10 I21 or I25, patients younger that 18 or older than 80, smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery DiseaseHeavy Metal Poisoning

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesPoisoningChemically-Induced Disorders

Study Officials

  • Jeanette Strametz-Juranek, Univ.Prof.Dr

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine II-Cardiology

Study Record Dates

First Submitted

December 5, 2012

First Posted

June 9, 2014

Study Start

September 1, 2010

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

June 9, 2014

Record last verified: 2014-06

Locations

AU(1)