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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00003193
Date of registration:	12/08/2011
Prospective Registration:	Yes
Primary sponsor:	Charité Campus Charité Mitte
Public title:	Evaluation of Ultrahigh-Field-MRI at 7 Tesla for Imaging of ischemic lesions, carotid plaque morphology and brain perfusion - 7 UP
Scientific title:	Evaluation of Ultrahigh-Field-MRI at 7 Tesla for Imaging of ischemic lesions, carotid plaque morphology and brain perfusion - 7 UP - 7-UP
Date of first enrolment:	18/08/2011
Target sample size:	100
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00003193
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
Phase:

Countries of recruitment
Germany

Contacts

Name:	Jan Sobesky
Address:	Charitéplatz1 11017 Berlin Germany
Telephone:	030 450 560 010
Email:	jan.sobesky@charite.de
Affiliation:	CSB-Centrum für Schlaganfallforschung

Name:	Jan Sobesky
Address:	Charitéplatz1 11017 Berlin Germany
Telephone:	030 450 560 010
Email:	jan.sobesky@charite.de
Affiliation:	CSB-Centrum für Schlaganfallforschung

Key inclusion & exclusion criteria

Inclusion criteria: General inclusion criteria:

- Stable patient condition not requiring in-hospital treatment
- Age: 18 – 80 years
- Preserved ability to give informed consent
- Informed consent
- Legal competence

Specific inclusion criteria

- sub-project 1:
o TIA
o Cortical/sub-cortical infarcts

- sub-project 2:
o internal or communal carotid artery stenosis (>50%) or as shown by Doppler sonography

- sub-project 3:
o internal carotid artery stenosis (>70%) or occlusion as shown by Doppler sonography

Exclusion criteria: Exclusion criteria:

- cardiac pacemaker or any other magnetic implant
- every kind of metallic or electro-(magnetic) implant
- pregnancy and breastfeeding period
- claustrophobia
- chronic or episodic vertigo
- diseases of the retina (e.g. retinal detachment or macula degeneration)

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cerebral infarction, unspecified

I63.9

I65.2

I63.9
I65.2

Occlusion and stenosis of carotid artery

Intervention(s)

Group 1: magnetic resonance maging at 3 Tesla and 7 Tesla

Primary Outcome(s)

part 1:

Number of microinfarcts after clinically proven transient ischemic attack, identified by 7 Tesla magnetic resonance imaging (MRI) in comparison to 3 Tesla MRI

part 2:

Discriminability of core and cap in carotid plaques at 7 Tesla in comparison to 3 Tesla.

part 3:

Perfusion measurement by ASL at 7 Tesla in comparison to 3 Tesla.

Secondary Outcome(s)

Secondary ID(s)

00013854

Source(s) of Monetary Support

Bundesministerium für Bildung und Forschung Dienstsitz Berlin

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 09/03/2011
Contact:

ethik-kommission@lageso.berlin.de

Ethik-Kommission des Landes Berlin

+49-30-902291220

ethik-kommission@lageso.berlin.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00003193#studyResults

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