Clinical trial NCT01284933: Carotid Plaque Imaging in Acute Stroke
Official title: Carotid Plaque Imaging in Acute Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Ischemic Attack, Transient
Keywords: Stroke
Ischemic Attack, Transient
Magnetic Resonance Imaging
Carotid Arteries
Carotid Artery Plaque
Atherosclerosis
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2011-01-27
Enrollment: 234
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to a specialized stroke service because of an acute stroke or TIA

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 49 years old
* Acute ischemic stroke or transient ischemic attack (TIA)
* Neurological symptoms compatible with a stroke or TIA in the anterior circulation (territory of the internal carotid artery)
* Onset of symptoms within the last 7 days
* 1 or more acute ischemic lesion(s) visible on MR diffusion-weighted imaging (DWI) in the territory of a single internal carotid artery
* Presence of carotid artery plaques in the ipsilateral or contralateral carotid artery as defined by ultrasound (criteria: plaque thickness at least 2mm; located within 1cm proximal or distal to the carotid bifurcation)
* Written informed consent

Exclusion Criteria:

* Primary referral to an outside hospital (to avoid recruitment bias)
* DWI positive lesions outside the territory of a single internal carotid artery
* Carotid artery stenosis \> 69% (North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria) ipsilateral to the stroke or TIA as defined by ultrasound (systolic peak flow velocity ≥ 300 cm/s)
* Standard contra-indications for MRI
* Documented allergy to MRI contrast media
* History of radiation to the neck area
* Renal clearance \< 30 ml/minute
* Creatinine levels \> 2 times the upper limit of the standard range of the respective laboratory within the last 30 days prior to MRI
* Surgical procedure within 24 hours preceding the MRI

Primary outcomes:
measure: 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
timeFrame: Baseline
Secondary outcomes:
measure: Pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery
timeFrame: Baseline
measure: Recurrence rates of AIS or TIA in patients with VP in the carotid artery
timeFrame: 12, 24, 36 Months
measure: Rate of new ischemic lesions on FLAIR MRI at 12 month follow-up in patients with VP in the carotid artery
timeFrame: 12 Months
measure: Association between VP in the carotid artery and atherosclerotic plaques in the aortic arch as determined by transoesophageal ultrasound
timeFrame: Baseline
measure: Biomarkers associated with vulnerable carotid artery plaques
timeFrame: Baseline
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University of Freiburg, Germany
state: Baden Württemberg
city: Munich
country: Germany
facility: Interdisciplinary Stroke Center Munich, Klinikum der Universität München
state: Bavaria
city: Munich
country: Germany
facility: Klinikum re. der Isar, Technical University Munich
state: Bavaria
city: Tübingen
country: Germany
facility: University of Tuebingen
Study officials:
affiliation: Institute for Stroke and Dementia Research, Klinikum der Universität München
name: Martin Dichgans, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiology, Klinikum der Universität München
name: Tobias Saam, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.