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
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
Scientific
Department of Nephrology and Hypertension
Inselspital University Hospital
Bern
3010
Switzerland
 ORCID ID |
0000-0001-7088-3652 |
|---|
Study information
| Study design | Observational cross-sectional case-control Study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Arterial stiffness and vascular function in patients with chronic periaortitis – a case-control study |
| Study objectives | Patients 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) studied | Chronic 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. |
| Intervention | We 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 type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Arterial 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 measures | Digital 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 date | 31/01/2008 |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 - 50 |
| Key inclusion criteria | Patients: 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 criteria | Patients with atrial fibrillation and other cardiac arrhythmias that interfered with study measurements |
| Date of first enrolment | 07/04/2008 |
| Date of final enrolment | 30/05/2008 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bern
3010
Switzerland
Sponsor information
Hospital/treatment centre
Department of Nephrology and Hypertension
Bern
3010
Switzerland
| Website | http://www.nephrologie.insel.ch/ |
|---|---|
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | We plan to publish the results in an open-access medical journal. |
| IPD sharing plan |
