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| Name | Class |
|---|---|
| Region Skane | OTHER |
| The Swedish Research Council | OTHER_GOV |
| Swedish Heart Lung Foundation | OTHER |
| Skåne University Hospital funds (incl. the Medical Training and Research Agreement/ALF) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid Plaque Imaging Project (CPIP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with carotid stenosis undergoing endarterectomy at Skåne University Hospital (SUS), Malmö, Sweden.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabel Goncalves, MD, PhD | Contact | +46 40 331000 | Isabel.Goncalves@med.lu.se |
| Name | Affiliation | Role |
|---|---|---|
| Isabel Goncalves, MD, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital (SUS) | Recruiting | Malmö | Skåne County | 214 28 | Sweden |
No sharing allowed due to General Data Protection Regulation (GDPR) legislation as sensitive personal data is included.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2024 | Oct 9, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| UNKNOWN |
| Swedish Foundation for Strategic Research | OTHER |
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Blood, plaque, images
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |