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Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikolaos Kadoglou, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00636766
First received: March 11, 2008
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

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

Secondary Outcome Measures:
  • Long-term cardiovascular outcomes [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nikolaos Kadoglou, MD,PhD, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00636766     History of Changes
Other Study ID Numbers: 887/2005
Study First Received: March 11, 2008
Last Updated: November 1, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
cardiovascular events

Additional relevant MeSH terms:
Atherosclerosis
Diabetes Mellitus, Type 2
Stroke
Metabolic Syndrome X
Carotid Artery Diseases
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Pathological Conditions, Anatomical
Rosiglitazone
Metformin
Atorvastatin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents

ClinicalTrials.gov processed this record on May 16, 2013