NCT00636766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 2, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

March 11, 2008

Last Update Submit

November 1, 2012

Conditions

Carotid AtherosclerosisStrokeType 2 DiabetesMetabolic Syndrome

Keywords

cardiovascular events

Outcome Measures

Primary Outcomes (1)

  • Ultrasound and immunohistochemical parameters of plaque stability; novel cardiovascular risk factors

    3 years

Secondary Outcomes (1)

  • Long-term cardiovascular outcomes

    3 years

Study Arms (1)

1

EXPERIMENTAL
Drug: atorvastatinDrug: rimonabantDrug: rosiglitazoneDrug: metformin

Interventions

atorvastatinDRUG

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)

1
rimonabantDRUG

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)

1
rosiglitazoneDRUG

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)

1
metforminDRUG

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)

1

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Carotid atherosclerosis
  • Femoral atherosclerosis
  • Cardiovascular risk

You may not qualify if:

  • Heart failure
  • Renal disease
  • Liver disease
  • Life-threatening diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Thessaloniki "Hippokratio"

Thessaloniki, Greece

Location

Related Publications (7)

  • Kadoglou NP, Moulakakis KG, Papadakis I, Ikonomidis I, Alepaki M, Spathis A, Karakitsos P, Lekakis J, Liapis CD. Differential effects of stent-graft fabrics on arterial stiffness in patients undergoing endovascular aneurysm repair. J Endovasc Ther. 2014 Dec;21(6):850-8. doi: 10.1583/14-4772MR.1.

    PMID: 25453890DERIVED

  • Moustardas P, Kadoglou NP, Katsimpoulas M, Kapelouzou A, Kostomitsopoulos N, Karayannacos PE, Kostakis A, Liapis CD. The complementary effects of atorvastatin and exercise treatment on the composition and stability of the atherosclerotic plaques in ApoE knockout mice. PLoS One. 2014 Sep 29;9(9):e108240. doi: 10.1371/journal.pone.0108240. eCollection 2014.

    PMID: 25264981DERIVED

  • Lambadiari V, Kadoglou NP, Stasinos V, Maratou E, Antoniadis A, Kolokathis F, Parissis J, Hatziagelaki E, Iliodromitis EK, Dimitriadis G. Serum levels of retinol-binding protein-4 are associated with the presence and severity of coronary artery disease. Cardiovasc Diabetol. 2014 Aug 21;13:121. doi: 10.1186/s12933-014-0121-z.

    PMID: 25142320DERIVED

  • Kadoglou NP, Tahmatzidis DK, Giannakoulas C, Kapelouzou A, Gkontopoulos A, Parissis J, Lampropoulos S, Kottas G. Serum levels of novel adipokines, omentin-1 and chemerin, in patients with acute myocardial infarction: KOZANI STUDY. J Cardiovasc Med (Hagerstown). 2015 May;16(5):341-6. doi: 10.2459/JCM.0000000000000053.

    PMID: 25022935DERIVED

  • Kadoglou NP, Lambadiari V, Gastounioti A, Gkekas C, Giannakopoulos TG, Koulia K, Maratou E, Alepaki M, Kakisis J, Karakitsos P, Nikita KS, Dimitriadis G, Liapis CD. The relationship of novel adipokines, RBP4 and omentin-1, with carotid atherosclerosis severity and vulnerability. Atherosclerosis. 2014 Aug;235(2):606-12. doi: 10.1016/j.atherosclerosis.2014.05.957. Epub 2014 Jun 8.

    PMID: 24956535DERIVED

  • Kadoglou NP, Fotiadis G, Lambadiari V, Maratou E, Dimitriadis G, Liapis CD. Serum levels of novel adipokines in patients with acute ischemic stroke: potential contribution to diagnosis and prognosis. Peptides. 2014 Jul;57:12-6. doi: 10.1016/j.peptides.2014.04.008. Epub 2014 Apr 24.

    PMID: 24768795DERIVED

  • Kadoglou NP, Sailer N, Fotiadis G, Kapelouzou A, Liapis CD. The impact of type 2 diabetes and atorvastatin treatment on serum levels of MMP-7 and MMP-8. Exp Clin Endocrinol Diabetes. 2014 Jan;122(1):44-9. doi: 10.1055/s-0033-1358762. Epub 2014 Jan 24.

    PMID: 24464597DERIVED

MeSH Terms

Conditions

Carotid Artery DiseasesStrokeDiabetes Mellitus, Type 2Metabolic Syndrome

Interventions

AtorvastatinRimonabantRosiglitazoneMetformin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsPyrazolesPiperidinesThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsBiguanidesGuanidinesAmidines

Study Officials

  • Christos Liapis, Professor

    University of Athens

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 14, 2008

Study Start

September 1, 2005

Primary Completion

December 1, 2007

Study Completion

January 1, 2009

Last Updated

November 2, 2012

Record last verified: 2012-11

Locations

GR(1)