Carotid Plaque Imaging in Acute Stroke (CAPIAS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Stroke Ischemic Attack, Transient |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Carotid Plaque Imaging in Acute Stroke |
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Recurrence rates of AIS or TIA in patients with VP in the carotid artery [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Association between VP in the carotid artery and atherosclerotic plaques in the aortic arch as determined by transoesophageal ultrasound [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Biomarkers associated with vulnerable carotid artery plaques [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, serum, plasma, RNA
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2011 |
| Groups/Cohorts |
|---|
|
Acute Ischemic Stroke, Transient Ischemic Attack
Patients admitted to a specialized stroke service because of an acute stroke or TIA
|
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients admitted to a specialized stroke service because of an acute stroke or TIA
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
Contacts and Locations| Contact: Martin Dichgans, Prof. | +49-89-7095 ext 8310 | martin.dichgans@med.uni-muenchen.de |
| Contact: Tobias Saam, MD | +49-89-7095 ext 3658 | tobias.saam@med.uni-muenchen.de |
| Germany | |
| University of Freiburg, Germany | Recruiting |
| Freiburg, Baden Württemberg, Germany, D-79106 | |
| Contact: Andreas Harloff, MD ++49-0761 270 ext 50010 andreas.harloff@uniklinik-freiburg.de | |
| Principal Investigator: Andreas Harloff, MD | |
| Klinikum re. der Isar, Technical University Munich | Recruiting |
| Munich, Bavaria, Germany, 81675 | |
| Contact: Holger Poppert, MD +49-89-4140 ext 4606 poppert@gmx.de | |
| Principal Investigator: Holger Poppert, MD | |
| Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern | Recruiting |
| Munich, Bavaria, Germany, 81377 | |
| Contact: Martin Dichgans, Prof. +49-89-7095 ext 8330 martin.dichgans@med.uni-muenchen.de | |
| Contact: Tobias Saam, MD +49-89-7095 ext 118 tobias.saam@med.uni-muenchen.de | |
| Principal Investigator: Martin Dichgans, Prof. | |
| Principal Investigator: Tobias Saam, MD | |
| Principal Investigator: | Martin Dichgans, Prof. | Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern |
| Principal Investigator: | Tobias Saam, MD | Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern |
More Information
Additional Information:
No publications provided
| Responsible Party: | Martin Dichgans, Prof., Ludwig-Maximilians - University of Munich |
| ClinicalTrials.gov Identifier: | NCT01284933 History of Changes |
| Other Study ID Numbers: | ISD-CAPIAS-01 |
| Study First Received: | January 24, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ludwig-Maximilians - University of Munich:
|
Stroke Ischemic Attack, Transient Magnetic Resonance Imaging |
Carotid Arteries Carotid Artery Plaque Atherosclerosis |
Additional relevant MeSH terms:
|
Ischemic Attack, Transient Ischemia Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction |
ClinicalTrials.gov processed this record on May 19, 2013