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StrokeCAPIASNCT01284933

Carotid Plaque Imaging in Acute Stroke

An observational study of Stroke and Ischemic Attack, Transient, run by Ludwig-Maximilians - University of Munich at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Stroke, Ischemic Attack, Transient
How many people
234 participants
Where
4 sitesGermany
Study dates
Feb 2011to Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • University of Freiburg, Germany

    Freiburg im Breisgau, Baden-Wurttemberg, D-79106

  • Interdisciplinary Stroke Center Munich, Klinikum der Universität München

    Munich, Bavaria, 81377

  • Klinikum re. der Isar, Technical University Munich

    Munich, Bavaria, 81675

  • University of Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

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.

Read the 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.

Keywords
Stroke, Ischemic Attack, Transient, Magnetic Resonance Imaging, Carotid Arteries, Carotid Artery Plaque, Atherosclerosis
Medical subject headings
Stroke, Ischemic Attack, Transient, Carotid Stenosis, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01284933
Study groupRoleWhat they receive
Acute Ischemic Stroke, TIAPatients admitted to a specialized stroke service because of an acute ischemic stroke or a transient ischemic attack (TIA).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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). 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

    Measured: Baseline

Secondary outcomes (5)

  1. 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.

    Measured: Baseline

  2. 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, 24 and 36 months.

    Measured: 12, 24, 36 Months

  3. 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.

    Measured: 12 Months

  4. 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.

    Measured: Baseline

  5. Biomarkers associated with vulnerable carotid artery plaques

    Biomarkers probably associated with vulnerable carotid artery plaques will be analyzed.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJul 2019
  4. Study completionJul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01284933
Sponsor's protocol ID
ISD-CAPIAS-01
Acronym
CAPIAS
Status last verified
Oct 2021
First submitted
24 Jan 2011
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24330333

  • 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.

    PubMed 23509049

  • 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.

    PubMed 33153580

  • 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.

    PubMed 35523659

  • 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.

    PubMed 33632492

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Ischemic Attack, Transient, run by Ludwig-Maximilians - University of Munich at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01284933, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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