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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
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The purpose of this study is to determine the frequency, characteristics, and consequences of vulnerable carotid artery plaques ipsilateral to an acute ischemic stroke or TIA in the territory of the internal carotid artery.
Even with extensive diagnostic workup the underlying etiology remains unidentified in about 25% of patients with acute ischemic stroke (AIS) or transient ischemic attack (TIA). Non-invasive high-resolution magnetic resonance imaging (HR-MRI) of the carotid artery allows detecting vulnerable plaques (VP) and quantifying single plaque components. The hypotheses behind this study are that i) a substantial proportion of cases of AIS and TIA within the anterior circulation and no identified cause (cryptogenic AIS or TIA) are caused by VP in the carotid artery; ii) that these patients are at a high risk of developing a recurrent stroke, TIA, or clinically silent lesions detectable by brain MRI; and iii) that VP in the carotid artery are associated with specific infarct patterns as detected by diffusion-weighted MR imaging. Finally, the investigators will search for biomarkers associated with vulnerable carotid artery plaques. Motivating this study are the following considerations: i) data on the frequency and characteristics of VP in patients with cryptogenic AIS or TIA will provide valuable insights into stroke mechanisms; ii) depending on the results this study may have implications for diagnostic decision making and provide the basis for the planning of targeted interventional studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Ischemic Stroke, TIA | Patients admitted to a specialized stroke service because of an acute ischemic stroke or a transient ischemic attack (TIA). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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:
| Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery | The pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery will be analyzed. | Baseline |
| Recurrence rates of AIS or TIA in patients with VP in the carotid artery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to a specialized stroke service because of an acute stroke or TIA
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Freiburg, Germany | Freiburg im Breisgau | Baden-Wurttemberg | D-79106 | Germany | ||
| Interdisciplinary Stroke Center Munich, Klinikum der Universität München |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24330333 | Background | Bayer-Karpinska A, Schwarz F, Wollenweber FA, Poppert H, Boeckh-Behrens T, Becker A, Clevert DA, Nikolaou K, Opherk C, Dichgans M, Saam T. The carotid plaque imaging in acute stroke (CAPIAS) study: protocol and initial baseline data. BMC Neurol. 2013 Dec 13;13:201. doi: 10.1186/1471-2377-13-201. | |
| 23509049 | Background |
| Label | URL |
|---|---|
| Click here for more information | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D016893 | Carotid Stenosis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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whole blood, serum, plasma, RNA
The recurrence rates of acute ischemic strokes or transient ischemic attacks will be evaluated at follow-up after 12, 24 and 36 months. |
| 12, 24, 36 Months |
| Rate of new ischemic lesions on FLAIR MRI at 12 month follow-up in patients with VP in the carotid artery | The rate of new ischemic lesions on FLAIR MRI will be evaluated at follow-up after 12 months. | 12 Months |
| Association between VP in the carotid artery and atherosclerotic plaques in the aortic arch as determined by transoesophageal ultrasound | 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. | Baseline |
| Biomarkers associated with vulnerable carotid artery plaques | Biomarkers probably associated with vulnerable carotid artery plaques will be analyzed. | Baseline |
| Munich |
| Bavaria |
| 81377 |
| Germany |
| Klinikum re. der Isar, Technical University Munich | Munich | Bavaria | 81675 | Germany |
| University of Tuebingen | Tübingen | 72076 | Germany |
| Schwarz F, Bayer-Karpinska A, Poppert H, Buchholz M, Cyran C, Grimm J, Helck A, Nikolaou K, Opherk C, Dichgans M, Saam T. Serial carotid MRI identifies rupture of a vulnerable plaque resulting in amaurosis fugax. Neurology. 2013 Mar 19;80(12):1171-2. doi: 10.1212/WNL.0b013e31828869ad. No abstract available. |
| 33153580 | Result | Kopczak A, Schindler A, Bayer-Karpinska A, Koch ML, Sepp D, Zeller J, Strecker C, Hempel JM, Yuan C, Malik R, Wollenweber FA, Boeckh-Behrens T, Cyran CC, Helck A, Harloff A, Ziemann U, Poli S, Poppert H, Dichgans M, Saam T. Complicated Carotid Artery Plaques as a Cause of Cryptogenic Stroke. J Am Coll Cardiol. 2020 Nov 10;76(19):2212-2222. doi: 10.1016/j.jacc.2020.09.532. |
| 35523659 | Derived | Kopczak A, Schindler A, Sepp D, Bayer-Karpinska A, Malik R, Koch ML, Zeller J, Strecker C, Janowitz D, Wollenweber FA, Hempel JM, Boeckh-Behrens T, Cyran CC, Helck A, Harloff A, Ziemann U, Poli S, Poppert H, Saam T, Dichgans M. Complicated Carotid Artery Plaques and Risk of Recurrent Ischemic Stroke or TIA. J Am Coll Cardiol. 2022 Jun 7;79(22):2189-2199. doi: 10.1016/j.jacc.2022.03.376. Epub 2022 May 3. |
| 33632492 | Derived | Kopczak A, Schindler A, Dichgans M, Saam T. Reply: Comparison of Different Plaque Imaging Techniques to Detect Complicated Carotid Artery Plaques. J Am Coll Cardiol. 2021 Mar 2;77(8):1147-1148. doi: 10.1016/j.jacc.2020.12.038. No abstract available. |
| Click here for more information | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D002340 | Carotid Artery Diseases |
| D001157 | Arterial Occlusive Diseases |
| D001161 | Arteriosclerosis |