Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Carotid Atherosclerosis Stroke Type 2 Diabetes Metabolic Syndrome |
| Intervention | Drug: atorvastatin Drug: rimonabant Drug: rosiglitazone Drug: metformin |
| Phase | N/A |
| Sponsor | Aristotle University Of Thessaloniki |
| Responsible Party | Aristotle University Of Thessaloniki |
| ClinicalTrials.gov Identifier | NCT00636766 |
| First Received | March 11, 2008 |
| Last Updated | November 1, 2012 |
| Last verified | November 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 11, 2008 |
|---|---|
| Last Updated Date | November 1, 2012 |
| Start Date | September 2005 |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures | Ultrasound and immunohistochemical parameters of plaque stability; novel cardiovascular risk factors [Time Frame: 3 years] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Long-term cardiovascular outcomes [Time Frame: 3 years] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque |
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| Official Title | Atherosclerotic Plaque Texture-Experimental and Clinical Study on the Diagnostic and Therapeutic Strategies of Atherosclerotic Plaque Vulnerability |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label |
| Condition |
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| Intervention | Drug: atorvastatin 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) Drug: rimonabant 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) Drug: rosiglitazone 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) Drug: metformin 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) |
| Study Arm (s) | Experimental: 1 |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 300 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | December 2007 |
| Eligibility Criteria | Inclusion Criteria: - Carotid atherosclerosis - Femoral atherosclerosis - Cardiovascular risk Exclusion Criteria: - Heart failure - Renal disease - Liver disease - Life-threatening diseases |
| Gender | Both |
| Ages | 50 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Greece |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00636766 |
|---|---|
| Other Study ID Numbers | 887/2005 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Aristotle University Of Thessaloniki |
| Study Sponsor | Aristotle University Of Thessaloniki |
| Collaborators | Not Provided |
| Investigators | Study Chair: Christos Liapis, Professor University of Athens |
| Verification Date | November 2012 |
Locations[ + expand ][ + ]
| General Hospital of Thessaloniki "Hippokratio" | Thessaloniki, Greece |
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