Natural History of Atherosclerosis

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918541
• Other study ID #: CarotidMRI
• Status: Completed
• Phase: N/A
• First received: November 19, 2008
• Last updated: December 22, 2011
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: December 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis

Locations

Country	Name	City	State
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Ospedale San Giovanni Bellinzona	Bellinzona
Switzerland	Cardiovascular Center Cardiology University Hospital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Districthospital of Bellinzona

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of atherosclerotic plaque		12 months	Yes