Natural History of Atherosclerosis

December 22, 2011 updated by: University of Zurich

Natural 1-year History of Atherosclerosis in Asymptomatic Patients With Mild to Moderate Carotid Stenosis

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland
        • Ospedale San Giovanni
      • Bellinzona, Switzerland
        • Ospedale San Giovanni Bellinzona
      • Zürich, Switzerland
        • Cardiovascular Center Cardiology University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the districthospital Bellinzona

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A
asymptomatic patients with mild to moderate carotid artery stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of atherosclerotic plaque
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Districthospital of Bellinzona

Investigators

  • Principal Investigator: Roberto Corti, MD, Cardiovascular Center Cardiology, University Hospital Zürich, Zürich Switzerland
  • Principal Investigator: Augusto Gallino, MD, Ospedale San Giovanni Bellinzona, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2011

Last Update Submitted That Met QC Criteria

December 22, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CarotidMRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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