Trial Review

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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
Evaluation of vascular risk markers in patients with systemic inflammation like patients with periaortitis or lupus in comparision to patients with and without arterial hypertension
Trial website
Trial related presentations / publications
Previous work of our research group:

Sollinger D, Mohaupt MG, Wilhelm A, Uehlinger D, Frey FJ, Eisenberger U. Arterial stiffness assessed by digital volume pulse correlates with comorbidity in patients with ESRD. Am J Kidney Dis 2006;48(3):456-63
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
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Documents added automatically
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