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Trial registered on ANZCTR


Registration number
ACTRN12610000843055
Ethics application status
Approved
Date submitted
21/09/2010
Date registered
6/10/2010
Date last updated
6/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Arterial stiffness in systemic inflammatory disease
Scientific title
Arterial stiffness in systemic inflammatory disease
(observational case-control study)
Secondary ID [1] 1086 0
CRG050800138 (Cochrane Renal Group)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
systemic inflammatory disease ( e.g. systemic lupus erythematodes, periaortits ) 243801 0
Condition category
Condition code
Renal and Urogenital 258410 258410 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 258411 258411 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Evaluation of vascular risk markers in different study populations (cross-sectional case-control design)
duration: 1 year
methods: arterial stiffness measured by pulse wave velocity; arterial blood pressure measured by spygnomanometry; evaluation of cardiovascular risk factors
(e.g. laboratory serum parameters like cholesterol, glycated hemiglobin and clinical assessment)
Intervention code [1] 257249 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259256 0
arterial stiffness measured by pulse wave velocity
Timepoint [1] 259256 0
at time of recruitment
Secondary outcome [1] 257540 0
-evaluation of cardiovascular risk factors
(e.g. laboratory serum parameters like cholesterol, glycated hemiglobin
tools: patient data information concering previous cardiovascular disease, smoking habits
Timepoint [1] 257540 0
at time of recruitment
Secondary outcome [2] 265656 0
endothelial dysfunction
test e.g. serum markers ( Assymmetric dimethylarginine)
Timepoint [2] 265656 0
at time of recruitment
Secondary outcome [3] 265657 0
arterial hypertension measured by automatic sphygnomanometry
Timepoint [3] 265657 0
at time of recruitment
Secondary outcome [4] 265658 0
evaluation of cardiovascular risk factors
(clinical assessment, medical tests)
Timepoint [4] 265658 0
at time of recruitment

Eligibility
Key inclusion criteria
- patients with active or chronic systemic inflammatory disease

- or patients arterial hypertension for more than 5 years

- healthy persons

- written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- cardiac arrhythmia

- patients / persons < 18 years of age

- women with a known pregancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2123 0
Switzerland
State/province [1] 2123 0

Funding & Sponsors
Funding source category [1] 243702 0
Hospital
Name [1] 243702 0
University Hospital Bern
Country [1] 243702 0
Switzerland
Primary sponsor type
Individual
Name
PD Dr. Eisenberger
Address
University Hopsital Bern
Freiburgstr. 10
3010 Bern
Country
Switzerland
Secondary sponsor category [1] 256905 0
None
Name [1] 256905 0
Address [1] 256905 0
Country [1] 256905 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30255 0
Address 30255 0
Country 30255 0
Phone 30255 0
Fax 30255 0
Email 30255 0
Contact person for public queries
Name 13502 0
PD Dr, Ute, Eisenberger
Address 13502 0
Senior resident, Nephrology and Hypertension, University Hospital Inselspital, Freiburgstrasse 10, CH-3010 Bern, Switzerland
Country 13502 0
Switzerland
Phone 13502 0
+41 31 6323144
Fax 13502 0
Email 13502 0
ute.eisenberger@insel.ch
Contact person for scientific queries
Name 4430 0
PD Dr, Ute, Eisenberger
Address 4430 0
Senior resident, Nephrology and Hypertension, University Hospital Inselspital, Freiburgstrasse 10, CH-3010 Bern, Switzerland
Country 4430 0
Switzerland
Phone 4430 0
+41 31 6323144
Fax 4430 0
Email 4430 0
ute.eisenberger@insel.ch

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.