Status:
UNKNOWN
The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Klinikum Chemnitz gGmbH
Conditions:
Carotid Stenosis
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to proof the concept of EP 1645 as a diagnostic tool for carotid artery atherosclerosis and plaque instability and to assess the safety and tolerability of this ...
Detailed Description
For the evaluation of atherosclerosis in carotid arteries up to now sonographic measurements of plaque burden are used. This method has advantages for investigation of carotid arteries since this regi...
Eligibility Criteria
Inclusion
- male and female with either symptomatic (\> 60%) or asymptomatic (\> 80%) carotid artery stenosis between 50 and 80 years of age
- Symptomatic stenosis of the A. carotis interna is defined as occurence of focal ischemic symptoms in the area of the supplying vessel, occurence of a transischemic attack (TIA), occurence of focal neurologic dysfunction or unilateral blindness.
- informed consent in accordance with ICH GCP and § 40 AMG and StrahlSchV
- sonography status from the patient is present (printout is available)
- patients available for carotid surgery within 3 months after diagnosis of carotid artery stenosis
- In patients with bilateral disease, only the stenosis considered for surgery will be included in the endpoint evaluation.
Exclusion
- patients \> 80 years
- major disease of the cardiovascular system, respiratory system, hepatobiliary system or CNS, which prevents patients from the study participation as to the opinion of the investigator
- hepatic (transaminases \> 3 x norm) or renal (serum creatinine increase \> 2x norm) insufficiency
- regular drug intake of biologics. Intake of all other drugs must be judged by investigator and must be the strictly documented
- previous administration of xenogenous proteins
- history of anaphylactic reaction to any drug administered by a parenteral pathway
- previous participation in a radiopharmaceutical drug trial (unless the effective dose acquired by participation in the current trial will remain below 10 mSv)
- participation in any clinical drug trial within 3 months prior to enrolment
- women of child-bearing potential (child-bearing potential to be ruled out by one of the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy, bilateral tubal ligation)
- Patients presenting clinical signs of severe systemic infection (CRP \> 50 mg/dl)
- Carotid Surgery (TEA) not possible within a time frame of 7 days after imaging
- Patients with bilateral carotid stenosis if clinically regarded as critical by the angiologists.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00904254
Start Date
January 1 2015
End Date
January 1 2016
Last Update
February 3 2012
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