Carotid Plaque Imaging in Acute Stroke (CAPIAS)
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|ClinicalTrials.gov Identifier: NCT01284933|
Recruitment Status : Recruiting
First Posted : January 27, 2011
Last Update Posted : August 29, 2017
|Condition or disease|
|Stroke Ischemic Attack, Transient|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Carotid Plaque Imaging in Acute Stroke|
|Actual Study Start Date :||February 2011|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2019|
Acute Ischemic Stroke, TIA
Patients admitted to a specialized stroke service because of an acute ischemic stroke or a transient ischemic attack (TIA).
- Frequency and characteristics of vulnerable plaques (VP) in the carotid artery ipsilateral to an acute ischemic stroke (AIS) or TIA in the territory of the carotid artery in patients with a cryptogenic stroke [ Time Frame: Baseline ]
For the primary outcome definition of a VP will be based on non-invasive high-resolution magnetic resonance imaging (MRI). Vulnerable plaques are defined as American Heart Association (AHA) class VI plaques (Cai et al. Circulation 2002; Saam et al.)
Comparisons will include:
- a comparison of the frequency and characteristics of VP ipsilateral vs. contralateral to the AIS or TIA
- a comparison of the frequency and characteristics of ipsilateral VP in patients with cryptogenic stroke as compared to patients with cardioembolic stroke or small vessel stroke
- Pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery [ Time Frame: Baseline ]The pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery will be analyzed.
- Recurrence rates of AIS or TIA in patients with VP in the carotid artery [ Time Frame: 12 Months ]The recurrence rates of acute ischemic strokes or transient ischemic attacks will be evaluated at follow-up after 12 months.
- Rate of new ischemic lesions on FLAIR MRI at 12 month follow-up in patients with VP in the carotid artery [ Time Frame: 12 Months ]The rate of new ischemic lesions on FLAIR MRI will be evaluated at follow-up after 12 months.
- Association between VP in the carotid artery and atherosclerotic plaques in the aortic arch as determined by transoesophageal ultrasound [ Time Frame: Baseline ]The association between VP in the carotid artery and atherosclerotic plaques in the aortic arch as determined by transoesophageal ultrasound will be evaluated in patients with transoesophageal ultrasound.
- Biomarkers associated with vulnerable carotid artery plaques [ Time Frame: Baseline ]Biomarkers probably associated with vulnerable carotid artery plaques will be analyzed.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284933
|Contact: Martin Dichgans, Prof.||+49-89-4400 ext email@example.com|
|Contact: Tobias Saam, Prof.||+49-89-4400 ext firstname.lastname@example.org|
|University of Freiburg, Germany||Recruiting|
|Freiburg, Baden Württemberg, Germany, D-79106|
|Contact: Andreas Harloff, Prof. ++49-0761 270 ext 50010 email@example.com|
|Principal Investigator: Andreas Harloff, Prof.|
|Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern||Recruiting|
|Munich, Bavaria, Germany, 81377|
|Contact: Martin Dichgans, Prof. +49-89-7095 ext 8330 firstname.lastname@example.org|
|Contact: Tobias Saam, MD +49-89-7095 ext 118 email@example.com|
|Principal Investigator: Martin Dichgans, Prof.|
|Principal Investigator: Tobias Saam, MD|
|Klinikum re. der Isar, Technical University Munich||Recruiting|
|Munich, Bavaria, Germany, 81675|
|Contact: Holger Poppert, Prof. +49-89-4140 ext 4606 firstname.lastname@example.org|
|Principal Investigator: Holger Poppert, Prof.|
|University of Tuebingen||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Ulf Ziemann, Prof. 0049 70712982049 email@example.com|
|Contact: Ulrike Ernemann, Prof. 0049 7071298 60 24 firstname.lastname@example.org|
|Principal Investigator: Ulf Ziemann, Prof.|
|Principal Investigator: Ulrike Ernemann, Prof.|
|Principal Investigator:||Martin Dichgans, Prof.||Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern|
|Principal Investigator:||Tobias Saam, Prof.||Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern|