Vascular DiseasesREBELNCT03732612
Inflammation in Vascular Disease
An observational study of Vascular Diseases and Atherosclerosis, run by Göteborg University at 1 site in Sweden.
Trial summary
Increasing evidence suggests that systemic low-grade inflammation may be a driving force of cardiometabolic complications, such as vascular dysfunction, atherosclerosis and ischemic heart disease. Thus, we will investigate the role of inflammation in cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases, Atherosclerosis
- How many people
- 170 participants
- Where
- 1 siteSweden
- Study dates
- 2 Sep 2019to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients planned for vascular reconstruction surgery at our center.
Who may be able to join
- Patient is planned to undergo vascular surgery.
- Signed informed consent has been obtained from the patient.
Who cannot join
- Patient has difficulty to understand information.
- Patients under 18 years of age.
- Patients participating in any drug-related study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
University of Gothenburg
Gothenburg, Vastragotaland, 40530
Emma Borgeson, PhD, +4631342000
Per Skoog, MD, PhD, +4631342000
About this study
Official title: The Role of Inflammation in Vascular Disease (Inflammationens Roll i kärlsjukdom)
Increasing evidence suggests that systemic low-grade inflammation may be a driving force of cardiometabolic complications, such as vascular dysfunction, atherosclerosis and ischemic heart disease. Thus, we will investigate the role of inflammation in cardiovascular disease.
Read the detailed description
Vascular reconstruction surgeries usually require a small piece of the vessel wall to be excised. The excised vessel is generally discarded as medical waste: however, for patients participating in the study, the excised tissue will be placed in saline and collected for research use.
Tissue collected from individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue will be cultured ex vivo in the presence or absence of therapeutic agents, to determine if these attenuate the inflammation associated with the atherosclerotic phenotype. Furthermore, the protocol will also be carried out using vascular tissue from control patients, which have undergone vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc).
- Conditions
- Vascular Diseases, Atherosclerosis
- Medical subject headings
- Vascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control patients | Control patients (n=20): In individuals undergoing vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc), a piece of healthy vessel must sometimes be removed in order to facilitate the surgical process. The vessel biopsies from this group will be categorized as "healthy vessels" in our study. | |
| Study patients | Study patients (n=150): In individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue is sometimes excised to facilitate the surgery. Biopsies from these individuals will be categorized as "vessels with vascular dysfunction". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory status
The inflammatory status will be studied in patients with atherosclerotic disease.
Measured: 2019-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start2 Sep 2019
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Boren, MD, PhD, Study director, The University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732612
- Sponsor's protocol ID
- 660-18
- Acronym
- REBEL
- Status last verified
- May 2025
- First submitted
- 5 Nov 2018
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inflammation in Vascular Disease (Inflammationens Roll i kärlsjukdom)
- ClinicalTrials.gov ID
- NCT03732612
- Acronym / sponsor ID
- REBEL / 660-18
- Conditions
- Vascular Diseases, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increasing evidence suggests that systemic low-grade inflammation may be a driving force of cardiometabolic complications, such as vascular dysfunction, atherosclerosis and ischemic heart disease. Thus, we will investigate the role of inflammation in cardiovascular disease.
Detailed description
Vascular reconstruction surgeries usually require a small piece of the vessel wall to be excised. The excised vessel is generally discarded as medical waste: however, for patients participating in the study, the excised tissue will be placed in saline and collected for research use.
Tissue collected from individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue will be cultured ex vivo in the presence or absence of therapeutic agents, to determine if these attenuate the inflammation associated with the atherosclerotic phenotype. Furthermore, the protocol will also be carried out using vascular tissue from control patients, which have undergone vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control patients | – | –Control patients (n=20): In individuals undergoing vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc), a piece of healthy vessel must sometimes be removed in order to facilitate the surgical process. The vessel biopsies from this group will be categorized as "healthy vessels" in our study. |
| Study patients | – | –Study patients (n=150): In individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue is sometimes excised to facilitate the surgery. Biopsies from these individuals will be categorized as "vessels with vascular dysfunction". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients planned for vascular reconstruction surgery at our center.
Key inclusion criteria (2 listed)
- Patient is planned to undergo vascular surgery.
- Signed informed consent has been obtained from the patient.
Key exclusion criteria (3 listed)
- Patient has difficulty to understand information.
- Patients under 18 years of age.
- Patients participating in any drug-related study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory status
Time frame: 2019-2024
The inflammatory status will be studied in patients with atherosclerotic disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Related trials for Vascular Diseases
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Boren, MD, PhD study director
The University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Atherosclerosis, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Borgeson, PhD (+46313420000, emma.borgeson@wlab.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory status (time frame: 2019-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.