Carotid Plaque Imaging in Acute Stroke

NCT01284933 | Completed

• 1 other identifier: ISD-CAPIAS-01
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Stroke; Ischemic Attack, Transient

Keywords

Stroke; Ischemic Attack, Transient; Magnetic Resonance Imaging; Carotid Arteries; Carotid Artery Plaque; Atherosclerosis

Outcome Measures

Primary Outcomes (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

  Baseline

Secondary Outcomes (5)

• Pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery

  Baseline

• Recurrence rates of AIS or TIA in patients with VP in the carotid artery

  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

  12 Months

• Association between VP in the carotid artery and atherosclerotic plaques in the aortic arch as determined by transoesophageal ultrasound

  Baseline

• Biomarkers associated with vulnerable carotid artery plaques

  Baseline

Study Arms (1)

Acute Ischemic Stroke, TIA

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Technical University of Munich: collaborator

Study Sites (4)

University of Freiburg, Germany

Freiburg im Breisgau, Baden-Wurttemberg, D-79106, Germany

Location

Interdisciplinary Stroke Center Munich, Klinikum der Universität München

Munich, Bavaria, 81377, Germany

Location

Klinikum re. der Isar, Technical University Munich

Munich, Bavaria, 81675, Germany

Location

University of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (5)

• 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.

  PMID: 24330333 BACKGROUND

• 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.

  PMID: 23509049 BACKGROUND

• 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.

  PMID: 33153580 RESULT

• 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.

  PMID: 35523659 DERIVED

• 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.

  PMID: 33632492 DERIVED

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, RNA

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Carotid Stenosis; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Carotid Artery Diseases; Arterial Occlusive Diseases; Arteriosclerosis

Study Officials

• Martin Dichgans, Prof.

  Institute for Stroke and Dementia Research, Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

• Tobias Saam, Prof.

  Department of Radiology, Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 27, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

DE (4)