Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Completed
• CT.gov ID: NCT00636766
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arm: 1
• Duration (Months): 40
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Atherosclerosis; Stroke; Type 2 Diabetes; Metabolic Syndrome	Drug: atorvastatin; Drug: rimonabant; Drug: rosiglitazone; Drug: metformin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Official Title: Atherosclerotic Plaque Texture-Experimental and Clinical Study on the Diagnostic and Therapeutic Strategies of Atherosclerotic Plaque Vulnerability
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 1

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)

Outcome Measures

Primary Outcome Measures

1. Ultrasound and immunohistochemical parameters of plaque stability; novel cardiovascular risk factors [3 years]

Secondary Outcome Measures

1. Long-term cardiovascular outcomes [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Carotid atherosclerosis

• Femoral atherosclerosis

• Cardiovascular risk

Exclusion Criteria:

• Heart failure

• Renal disease

• Liver disease

• Life-threatening diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Thessaloniki "Hippokratio"	Thessaloniki		Greece

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

• Study Chair: Christos Liapis, Professor, University of Athens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nikolaos Kadoglou, MD,PhD, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT00636766
• Other Study ID Numbers: 887/2005
• First Posted: Mar 14, 2008
• Last Update Posted: Nov 2, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Nikolaos Kadoglou, MD,PhD, Aristotle University Of Thessaloniki: cardiovascular events
• Additional relevant MeSH terms: Carotid Artery Diseases; Atherosclerosis; Metabolic Syndrome; Plaque, Atherosclerotic; Metformin; Rosiglitazone; Rimonabant; Atorvastatin

Study Results

No Results Posted as of Nov 2, 2012