Natural History of Atherosclerosis

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00918541
• Collaborator: Districthospital of Bellinzona (Other)
• Enrollment: 30
• Locations: 3
• Duration (Months): 37.9
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Natural 1-year History of Atherosclerosis in Asymptomatic Patients With Mild to Moderate Carotid Stenosis
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
A asymptomatic patients with mild to moderate carotid artery stenosis

Outcome Measures

Primary Outcome Measures

1. Progression of atherosclerotic plaque [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ospedale San Giovanni Bellinzona	Bellinzona		Switzerland
2	Ospedale San Giovanni	Bellinzona		Switzerland
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT00918541
• Other Study ID Numbers: CarotidMRI
• First Posted: Jun 11, 2009
• Last Update Posted: Dec 23, 2011
• Last Verified: Dec 1, 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

Study Results

No Results Posted as of Dec 23, 2011