NCT00918541

Brief Summary

20 patients will be recruited. The aim of the study is to determine the natural progression of atherosclerotic disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

January 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

Enrollment Period

3.2 years

First QC Date

November 19, 2008

Last Update Submit

December 22, 2011

Conditions

Atherosclerosis

Keywords

atherosclerotic diseaseprogressionnatural progression of atherosclerotic diseasenatural history of atherosclerosis at the level of the carotid artery as evaluated by MRI

Outcome Measures

Primary Outcomes (1)

  • Progression of atherosclerotic plaque

    12 months

Study Arms (1)

A

asymptomatic patients with mild to moderate carotid artery stenosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the districthospital Bellinzona

You may qualify if:

  • stable carotid artery disease not requiring revascularization
  • asymptomatic carotid artery stenosis \< 80% or symptomatic patients with stenosis \< 60 %
  • prophylactic therapy with aspirin (\> 100mg/day, statin, blood pressure therapy if indicated (goal \< 130/80 mmHg))
  • informed consent

You may not qualify if:

  • non atherosclerotic occlusive disease (Bürgers disease)
  • uncontrolled BP (DBP \> 110 mmHg and/or SBP \> 200 mmHg)
  • hemorrhagic disease or platelet count \< 100'000 mm\^3
  • Known active liver disease (elevations of GPT GOT or increased ammonia)
  • impaired renal function (crea \> 180 mmol/l)
  • pregnancy
  • severe claustrophobic reactions
  • short - term life - threatening pathology
  • physically unable to participate in the study
  • compliance not guaranteed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ospedale San Giovanni Bellinzona

Bellinzona, Switzerland

Location

Ospedale San Giovanni

Bellinzona, Switzerland

Location

Cardiovascular Center Cardiology University Hospital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

AtherosclerosisDisease Progression

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roberto Corti, MD

    Cardiovascular Center Cardiology, University Hospital Zürich, Zürich Switzerland

    PRINCIPAL INVESTIGATOR

  • Augusto Gallino, MD

    Ospedale San Giovanni Bellinzona, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2008

First Posted

June 11, 2009

Study Start

January 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations

CH(3)