NCT01773512

Brief Summary

  • The prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques.
  • Detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel reconstruction.
  • Prediction of changes in coronary arteries based on changes in non-invasive examinations.
  • Examination of WSS influence on atherosclerosis development and changes of WSS during lipid lowering therapy.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2012

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
2 countries

3 active sites

Status
unknown

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

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

January 16, 2013

Last Update Submit

January 18, 2013

Conditions

Coronary Artery Disease

Keywords

Intravascular ultrasoundVirtual histologyOptical coherence tomographyCoronary atherosclerosisStatinsRetinal imaging

Outcome Measures

Primary Outcomes (1)

  • The prediction of plaque volume and plaque composition.

    The study is looking for non-invasive predictors of plaque volume and plaque composition. The non-invasive predictors include carotid ultrasound, polymorphism in gene for heme-oxygenase 1 and retinal imaging.

    The patients will be followed in the study for one year

Secondary Outcomes (1)

  • Prediction of changes in plaque volume and plaque composition

    The patients will be followed in the study for one year.

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

All patients will be using rosuvastatin 40 mg

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

All patients will be using rosuvastatin 40 mg

Rosuvastatin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable angina pectoris

You may not qualify if:

  • age less than 18 or more than 80
  • renal insufficiency
  • liver insufficiency
  • pregnancy or , child potential without contraception
  • intolerance of statins
  • rhabdomyolysis or other myopathy in patient´s history
  • acute coronary syndrome in last 6 weeks
  • coronary anatomy unsuitable for intravascular ultrasound
  • active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Loyola University Hospital

Maywood, Illinois, 60153, United States

ACTIVE NOT RECRUITING

The University of Iowa

Iowa City, Iowa, 52242, United States

ACTIVE NOT RECRUITING

General University Hospital

Prague, 12808, Czechia

RECRUITING

Related Publications (3)

  • Kovarnik T, Kral A, Skalicka H, Mintz GS, Kralik L, Chval M, Horak J, Skalicka L, Sonka M, Wahle A, Downe RW, Uhrova J, Benakova H, Cernohousova L, Martasek P, Belohlavek J, Aschermann M, Linhart A. The prediction of coronary artery disease based on non-invasive examinations and heme oxygenase 1 polymorphism versus virtual histology. J Invasive Cardiol. 2013 Jan;25(1):32-7.

    PMID: 23293173BACKGROUND

  • Sonka M, Downe RW, Garvin JW, Lopez J, Kovarnik T, Wahle A. IVUS-based assessment of 3D morphology and virtual histology: prediction of atherosclerotic plaque status and changes. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6647-50. doi: 10.1109/IEMBS.2011.6091639.

    PMID: 22255863BACKGROUND

  • Kovarnik T, Chen Z, Mintz GS, Wahle A, Bayerova K, Kral A, Chval M, Kopriva K, Lopez J, Sonka M, Linhart A. Plaque volume and plaque risk profile in diabetic vs. non-diabetic patients undergoing lipid-lowering therapy: a study based on 3D intravascular ultrasound and virtual histology. Cardiovasc Diabetol. 2017 Dec 7;16(1):156. doi: 10.1186/s12933-017-0637-0.

    PMID: 29212544DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 23, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(2)CZ(1)