study of the carotid plaque

• Conditions: Carotid atherosclerosis at risk of atero-thrombosis; MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000648-83-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE DI MILANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-25
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patient of age > 40 and < 85 able to understand and to desire; monolateral carotid palque grade 40% -70 %
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Pregnancy and breast-feeding; renal filtrate < 60 ml; patient not able to coagulate;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the clinic utility in identifying carotid plaques at a higher risk of atero-thrombotic brain events.;Secondary Objective: n.a.;Primary end point(s): evaluation of association between increase of signal 11[C] PK11195 in plaque and presence/onset brain lesions detected by brain MRI;Timepoint(s) of evaluation of this end point: to 18 months Follow Up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.