Study to look at the variability of tests of blood vessel function in several different groups of people
| ISRCTN | ISRCTN16578656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16578656 |
| Secondary identifying numbers | CHDR2156 |
- Submission date
- 14/02/2022
- Registration date
- 07/03/2022
- Last edited
- 04/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
There are a lot of studies investigating medication that can potentially affect the characteristics of human blood vessels and how they work. To be able to properly explore these effects, reliable, safe and non-invasive tests are needed. This study aims to develop these tests, measuring how much they vary over time and between different people. In the study, different types of cameras and microscopes will be used to look at blood flow in the skin, oxygen content in the skin, the function of skin cells, function of blood vessels and characteristics of small blood vessels. These tests are further explained in the participant information sheet.
Who can participate?
Healthy adult volunteers aged 18 - 30 years.
What does the study involve?
The study consists of two visits, in which all tests described above are done once per participant. All of the tests are non-painful. Total duration of each visit is approximately 2 hours.
What are the possible benefits and risks of participating?
There are no direct benefits of participation in the study, but the data collected will help to improve research in the field. There are no risks associated with participation.
Where is the study run from?
Centre for Human Drug Research (the Netherlands)
When is the study starting and how long is it expected to run for?
December 2021 to February 2022
Who is funding the study?
Centre for Human Drug Research (the Netherlands)
Who is the main contact?
Dr Matthijs Moerland, mmoerland@chdr.nl
Contact information
Principal Investigator
Zernikedreef 8
Leiden
2333CL
Netherlands
 ORCID ID |
0000-0002-8064-8426 |
|---|---|
| Phone | +31 715246454 |
| mmoerland@chdr.nl |
Study information
| Study design | Observational single-centre longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | 41158.pdf |
| Scientific title | Observational study to evaluate inter-and intra-subject variability of microcirculatory and endothelial functional tests and differences in these tests between several subject populations |
| Study objectives | Functional tests of endothelial function and microcirculation can be used to evaluate clinical effects in clinical trials. |
| Ethics approval(s) | No ethics approval required (non-WMO research) |
| Health condition(s) or problem(s) studied | Endothelial function and microcirculatory function |
| Intervention | Eight healthy volunteers will be assessed in this study on two separate study days. The Screening Visit will be conducted at day 1. Each study day subjects will undergo a battery of endothelial testing, which consists of the following measurements: Flow Mediated Skin Fluorescence (FMSF), laser speckle contrast imaging (LSCI), near infrared spectroscopy (NIRS), side-stream dark field microscopy (SDFM) and passive leg movement (PLM), in no particular order. However, LSCI_LTH measurements will be performed after LSCI_PORH. |
| Intervention type | Other |
| Primary outcome measure | Endothelial function and microcirculation measured with FMSF, LSCI, NIRS, SDFM and PLM on two study days |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 03/12/2021 |
| Completion date | 20/02/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8 |
| Key inclusion criteria | 1. Male and females, 18 to 30 years of age, inclusive. 2. Subject has voluntarily signed informed consent form. 3. Willingness and ability to comply with all study procedures 4. Body mass index (BMI) between 18 and 30 kg/m² |
| Key exclusion criteria | 1. Evidence of any active or chronic disease or condition that could interfere with the conduct of the study (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature). 2. Receival of any study drug within 30 days or 5 times ½ half-life, whichever greater prior to day 1. 3. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study). 4. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent. 5. Alcohol intake 24h prior to the study day. 6. Is demonstrating excess in caffeine consumption (more than eight cups of coffee or equivalent per day. 7. If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study 8. Any daily nicotine use or regular use of nicotine products. 9. Positive nasopharyngeal rapid antigen test for SARS-CoV-2 at admission to the clinical research center 10. Subject has received any vaccination in the last 2 weeks prior to Visit 1 |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 12/02/2022 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden
2333CL
Netherlands
Sponsor information
Research organisation
Zernikedreef 8
Leiden
2333CL
Netherlands
| Phone | +31 71 524 6400 |
|---|---|
| info@chdr.nl | |
| Website | http://www.chdr.nl/ |
"ROR" |
https://ror.org/044hshx49 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 20/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal, possibly combined with data from other trials running at CHDR. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from CHDR project leader or principal investigator. (clintrials@chdr.nl) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 08/12/2021 | 18/02/2022 | No | Yes |
| Protocol file | version 1 | 08/12/2021 | 18/02/2022 | No | No |
| Results article | 12/05/2023 | 04/04/2024 | Yes | No |
Additional files
Editorial Notes
04/04/2024: Publication reference added.
22/02/2022:Trial's existence confirmed by Centre for Human Drug Research
