Carotid atherosclerosis at risk of atero-thrombosis MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: 1[C]PK11195
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 11[C]PK11195
Concentration unit: MBq/kg megabecquerel(s)/kilogram
Concentration type: not le
Sponsors
OSPEDALE S. RAFFAELE DI MILANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient of age > 40 and =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Pregnancy and breast-feeding; renal filtrate < 60 ml; patient not able to coagulate;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a. | — |
Countries
Italy
Contacts
Public ContactDip. cardio-toraco-vascolare
Fondazione San Raffaele del Monte Tabor
Outcome results
None listed