Carotid Plaque Imaging in Acute Stroke (CAPIAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01284933|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2011
Last Update Posted : October 5, 2020
|Condition or disease|
|Stroke Ischemic Attack, Transient|
|Study Type :||Observational|
|Actual Enrollment :||234 participants|
|Official Title:||Carotid Plaque Imaging in Acute Stroke|
|Actual Study Start Date :||February 2011|
|Actual Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2021|
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). We will classify plaques according to the American Heart Association - Lesion Type (AHA-LT) classification (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, 24, 36 Months ]The recurrence rates of acute ischemic strokes or transient ischemic attacks will be evaluated at follow-up after 12, 24 and 36 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
|University of Freiburg, Germany|
|Freiburg, Baden Württemberg, Germany, D-79106|
|Interdisciplinary Stroke Center Munich, Klinikum der Universität München|
|Munich, Bavaria, Germany, 81377|
|Klinikum re. der Isar, Technical University Munich|
|Munich, Bavaria, Germany, 81675|
|University of Tuebingen|
|Tübingen, Germany, 72076|
|Principal Investigator:||Martin Dichgans, Prof.||Institute for Stroke and Dementia Research, Klinikum der Universität München|
|Principal Investigator:||Tobias Saam, Prof.||Department of Radiology, Klinikum der Universität München|