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Carotid Plaque Imaging in Acute Stroke (CAPIAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ludwig-Maximilians - University of Munich
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Martin Dichgans, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01284933
First received: January 24, 2011
Last updated: April 4, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

Patients admitted to a specialized stroke service because of an acute stroke or TIA

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284933

Contacts
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

Locations
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         
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         
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         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Technische Universität München
Investigators
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:
Publications:
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: April 4, 2014
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
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014