Carotid Plaque Imaging in Acute Stroke (CAPIAS)

October 5, 2021 updated by: Martin Dichgans, Ludwig-Maximilians - University of Munich
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University of Tuebingen
    • Baden Württemberg
      • Freiburg, Baden Württemberg, Germany, D-79106
        • University of Freiburg, Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Interdisciplinary Stroke Center Munich, Klinikum der Universität München
      • Munich, Bavaria, Germany, 81675
        • Klinikum re. der Isar, Technical University Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute Ischemic Stroke, TIA
Patients admitted to a specialized stroke service because of an acute ischemic stroke or a transient ischemic attack (TIA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Baseline

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:

  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery
Time Frame: Baseline
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
Time Frame: 12, 24, 36 Months
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
Time Frame: 12 Months
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
Time Frame: Baseline
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
Time Frame: Baseline
Biomarkers probably associated with vulnerable carotid artery plaques will be analyzed.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Technical University of Munich

Investigators

  • Principal Investigator: Tobias Saam, Prof., Department of Radiology, Klinikum der Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2011

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

July 1, 2021

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (ESTIMATE)

January 27, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISD-CAPIAS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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