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Natural History of Atherosclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918541
First Posted: June 11, 2009
Last Update Posted: December 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Districthospital of Bellinzona
Information provided by (Responsible Party):
University of Zurich
  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:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Progression of atherosclerotic plaque [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00918541     History of Changes
Other Study ID Numbers: CarotidMRI
First Submitted: November 19, 2008
First Posted: June 11, 2009
Last Update Posted: December 23, 2011
Last Verified: December 2011

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