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Natural History of Atherosclerosis

This study has been completed.
Sponsor:
Collaborator:
Districthospital of Bellinzona
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00918541
First received: November 19, 2008
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural 1-year History of Atherosclerosis in Asymptomatic Patients With Mild to Moderate Carotid Stenosis

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Progression of atherosclerotic plaque [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
asymptomatic patients with mild to moderate carotid artery stenosis

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of the districthospital Bellinzona

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918541

Locations
Switzerland
Ospedale San Giovanni Bellinzona
Bellinzona, Switzerland
Ospedale San Giovanni
Bellinzona, Switzerland
Cardiovascular Center Cardiology University Hospital Zürich
Zürich, Switzerland
Sponsors and Collaborators
University of Zurich
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
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00918541     History of Changes
Other Study ID Numbers: CarotidMRI
Study First Received: November 19, 2008
Last Updated: December 22, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
atherosclerotic disease
progression
natural progression of atherosclerotic disease
natural history of atherosclerosis at the level of the carotid artery as evaluated by MRI

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013