Carotid Plaque Imaging Project (CPIP)

Sponsor
Lund University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05821894
Collaborator
Region Skåne (Other), The Swedish Research Council (Other), Swedish Heart Lung Foundation (Other), Skåne University Hospital funds (incl. the Medical Training and Research Agreement/ALF) (Other), Swedish Foundation for Strategic Research (Other)
2,000
1
289.2
6.9

Study Details

Study Description

Brief Summary

The rupture or erosion of an atherosclerotic plaque with thrombosis or embolization often underlie heart attacks and strokes. The early identification of patients with atherosclerotic plaques prone to rupture or erosions, vulnerable plaques (VP), and their treatment before the occurrence of events is, therefore, one of the greatest cardiovascular challenges today. Possible approaches for early detection of VP include imaging techniques allowing visualization of plaque structure, circulating biomarkers and better understanding of the pathophysiologic mechanisms of the disease. In the carotid plaque imaging project the investigators study human atherosclerotic plaques (that are removed by endarterectomy) to disclose their underlying structure and mechanisms, finding possible novel therapeutic targets or markers for VP. The investigators also study plaque structure with imaging methods and try to develop new ways to detect VP using circulating or imaging markers.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational study

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Carotid Plaque Imaging Project (Identification of Vulnerable Atherosclerotic Plaques With Imaging and Biological Markers)
Actual Study Start Date :
Oct 26, 2005
Anticipated Primary Completion Date :
Dec 1, 2029
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Carotid Plaque Imaging Project (CPIP)

Other: Observational study

Outcome Measures

Primary Outcome Measures

  1. Number of participants suffering post-operative cardiovascular events (by 2025) [Follow up assessment year 2025 (recording of events occurring since 2023)]

    Post-operative myocardial infarction, stroke, transient ischaemic attack, amaurosis fugax, cardiovascular death (according to Swedish National Registers)

  2. Number of participants suffering post-operative cardiovascular events (by 2027) [Follow up assessment year 2027 (recording of events occurring since 2025)]

    Post-operative myocardial infarction, stroke, transient ischaemic attack, amaurosis fugax, cardiovascular death (according to Swedish National Registers)

  3. Number of participants suffering post-operative cardiovascular events (by 2029) [Follow up assessment year 2029 (recording of events occurring since 2027)]

    Post-operative myocardial infarction, stroke, transient ischaemic attack, amaurosis fugax, cardiovascular death (according to Swedish National Registers)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients older than 18 years old, male or female that are eligible for carotid endarterectomy due to atherosclerosis and that can provide informed consent.
Exclusion Criteria:
  • Patients younger than 18 years old that cannot provide informed consent; pregnant.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Skåne University Hospital (SUS) Malmö Skåne Sweden 214 28

Sponsors and Collaborators

  • Lund University
  • Region Skåne
  • The Swedish Research Council
  • Swedish Heart Lung Foundation
  • Skåne University Hospital funds (incl. the Medical Training and Research Agreement/ALF)
  • Swedish Foundation for Strategic Research

Investigators

  • Principal Investigator: Isabel Goncalves, MD, PhD, Lund University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Lund University
ClinicalTrials.gov Identifier:
NCT05821894
Other Study ID Numbers:
  • CPIP
First Posted:
Apr 20, 2023
Last Update Posted:
Apr 20, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2023