Carotid Plaque Imaging in Acute Stroke

NCT ID: NCT01284933

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2021-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Ischemic Attack, Transient

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute Ischemic Stroke, TIA

Patients admitted to a specialized stroke service because of an acute ischemic stroke or a transient ischemic attack (TIA).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technical University of Munich

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Martin Dichgans

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Dichgans, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute for Stroke and Dementia Research, Klinikum der Universität München

Tobias Saam, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Klinikum der Universität München

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Freiburg, Germany

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Interdisciplinary Stroke Center Munich, Klinikum der Universität München

Munich, Bavaria, Germany

Site Status

Klinikum re. der Isar, Technical University Munich

Munich, Bavaria, Germany

Site Status

University of Tuebingen

Tübingen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24330333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23509049 (View on PubMed)

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.

Reference Type RESULT
PMID: 33153580 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35523659 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33632492 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ISD-CAPIAS-01

Identifier Type: -

Identifier Source: org_study_id