Inflammation in Vascular Disease

Atherosclerosis Clinical Trial

— REBEL  

Official title:

The Role of Inflammation in Vascular Disease (Inflammationens Roll i kärlsjukdom)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03732612
• Other study ID #: 660-18
• Status: Recruiting
• Start date: September 2, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2020
• Source: Göteborg University
• Contact: Emma Borgeson, PhD
• Phone: +46313420000
• Email: emma.borgeson[@]wlab.gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is planned to undergo vascular surgery.

• Signed informed consent has been obtained from the patient.

Exclusion Criteria:

• Patient has difficulty to understand information.

• Patients under 18 years of age.

• Patients participating in any drug-related study.

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation
• Vascular Diseases

Locations

Country	Name	City	State
Sweden	University of Gothenburg	Gothenburg	Vastragotaland

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory status	The inflammatory status will be studied in patients with atherosclerotic disease.	2019-2024