Carotid Plaque Imaging Project (CPIP)

NCT05821894 | Recruiting DMC

• 1 other identifier: CPIP
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Atherosclerotic Plaque

Outcome Measures

Primary Outcomes (3)

• Number of participants suffering post-operative cardiovascular events (by 2025)

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

  Follow up assessment year 2025 (recording of events occurring since 2023)

• Number of participants suffering post-operative cardiovascular events (by 2027)

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

  Follow up assessment year 2027 (recording of events occurring since 2025)

• Number of participants suffering post-operative cardiovascular events (by 2029)

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

  Follow up assessment year 2029 (recording of events occurring since 2027)

Study Arms (1)

Carotid Plaque Imaging Project (CPIP)

Other: Observational study

Interventions

Observational study OTHER

Carotid Plaque Imaging Project (CPIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with carotid stenosis undergoing endarterectomy at Skåne University Hospital (SUS), Malmö, Sweden.

You may qualify if:

• Patients older than 18 years old, male or female that are eligible for carotid endarterectomy due to atherosclerosis and that can provide informed consent.

You may not qualify if:

• Patients younger than 18 years old that cannot provide informed consent; pregnant.

Sponsors & Collaborators

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

Study Sites (1)

Skåne University Hospital (SUS)

Malmo, Skåne County, 214 28, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plaque, images

MeSH Terms

Conditions

Atherosclerosis; Plaque, Atherosclerotic

Interventions

Observation

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Isabel Goncalves, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Goncalves, MD, PhD

CONTACT

+46 40 331000; Isabel.Goncalves@med.lu.se

Study Design

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

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 20, 2023
• Study Start: October 26, 2005
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)