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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01284933
Other study ID # ISD-CAPIAS-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2011
Est. completion date January 2020

Study information

Verified date August 2018
Source Ludwig-Maximilians - University of Munich
Contact Martin Dichgans, Prof.
Phone +49-89-4400
Email martin.dichgans@med.uni-muenchen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date January 2020
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University of Freiburg, Germany Freiburg Baden Württemberg
Germany Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern Munich Bavaria
Germany Klinikum re. der Isar, Technical University Munich Munich Bavaria
Germany University of Tuebingen Tübingen

Sponsors (2)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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
Baseline
Secondary 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
Secondary Recurrence rates of AIS or TIA in patients with VP in the carotid artery The recurrence rates of acute ischemic strokes or transient ischemic attacks will be evaluated at follow-up after 12 months. 12 Months
Secondary 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
Secondary 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
Secondary Biomarkers associated with vulnerable carotid artery plaques Biomarkers probably associated with vulnerable carotid artery plaques will be analyzed. Baseline
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