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Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636766
First Posted: March 14, 2008
Last Update Posted: November 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nikolaos Kadoglou, Aristotle University Of Thessaloniki
  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.

Condition Intervention
Carotid Atherosclerosis Stroke Type 2 Diabetes Metabolic Syndrome Drug: atorvastatin Drug: rimonabant Drug: rosiglitazone Drug: metformin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nikolaos Kadoglou, Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Ultrasound and immunohistochemical parameters of plaque stability; novel cardiovascular risk factors [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Long-term cardiovascular outcomes [ Time Frame: 3 years ]

Enrollment: 300
Study Start Date: September 2005
Study Completion Date: January 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Carotid atherosclerosis
  • Femoral atherosclerosis
  • Cardiovascular risk

Exclusion Criteria:

  • Heart failure
  • Renal disease
  • Liver disease
  • Life-threatening diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636766


Locations
Greece
General Hospital of Thessaloniki "Hippokratio"
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Chair: Christos Liapis, Professor University of Athens
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nikolaos Kadoglou, MD,PhD, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00636766     History of Changes
Other Study ID Numbers: 887/2005
First Submitted: March 11, 2008
First Posted: March 14, 2008
Last Update Posted: November 2, 2012
Last Verified: November 2012

Keywords provided by Nikolaos Kadoglou, Aristotle University Of Thessaloniki:
cardiovascular events

Additional relevant MeSH terms:
Metabolic Syndrome X
Atherosclerosis
Carotid Artery Diseases
Plaque, Atherosclerotic
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Rosiglitazone
Metformin
Atorvastatin Calcium
Rimonabant
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors