Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

Study Overview
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Brief Summary
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The aim of the present study is to examine the atherosclerotic plaque stability using in vivo and in vitro techniques and to investigate the influence of exercise, anti-diabetic, lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in patients with cardiovascular risk and animals prone to atherosclerosis.

Official Title
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Atherosclerotic Plaque Texture-Experimental and Clinical Study on the Diagnostic and Therapeutic Strategies of Atherosclerotic Plaque Vulnerability

Conditions
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Carotid Atherosclerosis, Stroke, Type 2 Diabetes, Metabolic Syndrome

Intervention / Treatment
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* Drug: atorvastatin
* Drug: rimonabant
* Drug: rosiglitazone
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carotid atherosclerosis Femoral atherosclerosis Cardiovascular risk Exclusion Criteria: Heart failure Renal disease Liver disease Life-threatening diseases

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: atorvastatin<br>* A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)<br>Drug: rimonabant<br>* A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)<br>Drug: rosiglitazone<br>* A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)<br>Drug: metformin<br>* A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound and immunohistochemical parameters of plaque stability; novel cardiovascular risk factors |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term cardiovascular outcomes |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular events