Vascular function in patients with chronic vessel inflammation

ISRCTN ISRCTN92088047
DOI https://doi.org/10.1186/ISRCTN92088047
Secondary identifying numbers 1491
Submission date
05/01/2016
Registration date
09/01/2016
Last edited
07/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic periaortitis is a rare disease of unknown cause that leads to inflammatory tissue around the body's main artery, the aorta. It is known that increased arterial stiffness is associated with an increased risk of heart disease and death. We aim to study arterial stiffness in patients with chronic periaortitis.

Who can participate?
Patients with chronic periaortitis, patients with high blood pressure, and 16 healthy volunteers, matched for sex and age (age range: 34 to 74).

What does the study involve?
Participants have their arterial stiffness measured with two methods: pulse wave velocity (a probe placed over the neck artery and the main leg artery) and digital volume pulse (a probe placed on the index finger). We study the change of digital volume pulse before and after giving the patients the drug nitroglycerin sublingually (under the tongue).

What are the possible benefits and risks of participating?
Benefits include knowing whether you have a marker of heart disease risk and contributing to knowledge about a very rare disease. Sublingual nitroglycerin can sometimes cause a headache, sickness and dizziness. These side effects usually last less than 10 minutes and are not dangerous.

Where is the study run from?
University Hospital of Bern (Switzerland).

When is the study starting and how long is it expected to run for?
January to May 2008.

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Claudia Scheuter

Contact information

Dr Claudia Scheuter
Scientific

Department of Nephrology and Hypertension
Inselspital University Hospital
Bern
3010
Switzerland

ORCiD logoORCID ID 0000-0001-7088-3652

Study information

Study designObservational cross-sectional case-control Study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleArterial stiffness and vascular function in patients with chronic periaortitis – a case-control study
Study objectivesPatients with periaortitis show an elevated arterial stiffness and a reduced vascular function
Ethics approval(s)Kantonale Ethikkommission Bern (Ethics Committee of the State of Bern, Switzerland), 07/04/2008, ref: 025/08
Health condition(s) or problem(s) studiedChronic periaortitis, also known as Ormond’s disease or retroperitoneal fibrosis is a rare disease of unknown etiology with pathological features of vascular inflammation and fibrosis.
InterventionWe compared arterial stiffness and endothelial function in 16 patients with chronic periaortitis to age- and sex-matched hypertensive and healthy controls in a 1:1 distribution. Aortic stiffness was assessed by carotid-to-femoral pulse wave velocity with Doppler measurements. Endothelium-independent vasodilation was assessed before and after sublingual administration of glyceryl trinitrate by analyzing changes in arterial stiffness using digital volume pulse (DVP) and the DVP derived stiffness index (SIDVP).
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureArterial stiffness, measured by pulse wave velocity (PWV). PWV was recorded in a single session, using a Pulse Trace PWV© (Micro Medical Ltd, Rochester, Kent, UK) with a 4-MHz continuous wave directional Doppler pencil probe. Pulse Trace PWV© calculates the time lag between the R wave of the electrocardiogram and the arrival of the arterial pulse wave at 2 different sites, thus inferring pulse wave velocity. First, electrodes for an electrocardiogram are placed, followed by placing the Doppler probe over (1) the right carotid artery and (2) the right or left femoral artery. The position of the Doppler probe is optimized at each site to achieve a signal of sufficient quality (i.e. stable pulse waveform). About 10 systolic peaks are recorded at both sites to obtain a mean time lag at the carotid artery and at the femoral artery. The distance between the 2 detection sites is measured.
Secondary outcome measuresDigital volume pulse (DVP) as a measure for endothelial function, blood pressure, heart rate and pulse pressure. DVP was measured photoplethysmographically in the same single session as PWV, using the Pulse Trace© Pulse Contour Analysis device (Micro Medical Ltd, Rochester, Kent, UK). The probe were placed on the index finger of the dominant hand. Pulse contour waves recorded over a period of 10 seconds were averaged by the device to a single waveform. Blood pressure was measured while participants were recumbent for at least 10 minutes.
Overall study start date31/01/2008
Completion date30/05/2008

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants45 - 50
Key inclusion criteriaPatients: patients with a diagnosis of chronic periaortitis that were followed at our outpatient clinic for Nephrology and Hypertension and patients with known arterial hypertension that were followed at our outpatient clinic for Nephrology and Hypertension, matched for age and sex in a 1:1 fashion.

Healthy volunteers: healthy volunteers from the community and clinic staff, matched 1:1 for age and sex.
Key exclusion criteriaPatients with atrial fibrillation and other cardiac arrhythmias that interfered with study measurements
Date of first enrolment07/04/2008
Date of final enrolment30/05/2008

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Inselspital University Hospital Bern
Department of Nephrology and Hypertension
Bern
3010
Switzerland

Sponsor information

Inselspital University Hospital Bern (Switzerland)
Hospital/treatment centre

Department of Nephrology and Hypertension
Bern
3010
Switzerland

Website http://www.nephrologie.insel.ch/
ROR logo "ROR" https://ror.org/01q9sj412

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planWe plan to publish the results in an open-access medical journal.
IPD sharing plan