Carotid Plaque Imaging Project (CPIP)

Atherosclerosis Clinical Trial

— CPIP  

Official title:

Carotid Plaque Imaging Project (Identification of Vulnerable Atherosclerotic Plaques With Imaging and Biological Markers)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821894
• Other study ID #: CPIP
• Status: Recruiting
• Start date: October 26, 2005
• Est. completion date: December 2029

Study information

• Verified date: April 2023
• Source: Lund University
• Contact: Isabel Goncalves, MD, PhD
• Phone: +46 40 331000
• Email: Isabel.Goncalves[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Plaque
• Plaque, Atherosclerotic

Intervention

Other:
• Observational study

Locations

Country	Name	City	State
Sweden	Skåne University Hospital (SUS)	Malmö	Skåne

Sponsors (6)

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

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)