NCT03732612

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Sep 2019Feb 2027

First Submitted

Initial submission to the registry

November 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

6.4 years

First QC Date

November 5, 2018

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inflammatory status

    The inflammatory status will be studied in patients with atherosclerotic disease.

    2019-2024

Study Arms (2)

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".

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients planned for vascular reconstruction surgery at our center.

You may qualify if:

  • Patient is planned to undergo vascular surgery.
  • Signed informed consent has been obtained from the patient.

You may not qualify if:

  • Patient has difficulty to understand information.
  • Patients under 18 years of age.
  • Patients participating in any drug-related study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Vastragotaland, 40530, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Vascular tissue.

MeSH Terms

Conditions

Vascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Jan Boren, MD, PhD

    The University of Gothenburg

    STUDY DIRECTOR

Central Study Contacts

Emma Borgeson, PhD

CONTACT

Per Skoog, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 6, 2018

Study Start

September 2, 2019

Primary Completion

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations