Inflammation in Vascular Disease

NCT ID: NCT03732612

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-02

Study Completion Date

2027-02-01

Brief Summary

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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

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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

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Vascular Diseases Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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".

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Boren, MD, PhD

Role: STUDY_DIRECTOR

The University of Gothenburg

Locations

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University of Gothenburg

Gothenburg, Vastragotaland, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Emma Borgeson, PhD

Role: CONTACT

+46313420000

Per Skoog, MD, PhD

Role: CONTACT

+46313420000

Facility Contacts

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Emma Borgeson, PhD

Role: primary

+4631342000

Per Skoog, MD, PhD

Role: backup

+4631342000

Other Identifiers

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660-18

Identifier Type: -

Identifier Source: org_study_id

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