CAPIAS: Carotid Plaque Imaging in Acute Stroke

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT01284933

Collaborator

Technische Universität München (Other)

234

Enrollment

Locations

124.9

Actual Duration (Months)

58.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Ischemic Attack, Transient

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 Design

Study Type:

Observational

Actual Enrollment :

234 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Carotid Plaque Imaging in Acute Stroke

Actual Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2021

Arms and Interventions

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

Outcome Measures

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 [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

Secondary Outcome Measures

Pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery [Baseline]
The pattern of acute ischemic lesions on brain MRI associated with VP in the carotid artery will be analyzed.
Recurrence rates of AIS or TIA in patients with VP in the carotid artery [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.
Rate of new ischemic lesions on FLAIR MRI at 12 month follow-up in patients with VP in the carotid artery [12 Months]
The rate of new ischemic lesions on FLAIR MRI will be evaluated at follow-up after 12 months.
Association between VP in the carotid artery and atherosclerotic plaques in the aortic arch as determined by transoesophageal ultrasound [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.
Biomarkers associated with vulnerable carotid artery plaques [Baseline]
Biomarkers probably associated with vulnerable carotid artery plaques will be analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Freiburg, Germany	Freiburg	Baden Württemberg	Germany	D-79106
2	Interdisciplinary Stroke Center Munich, Klinikum der Universität München	Munich	Bavaria	Germany	81377
3	Klinikum re. der Isar, Technical University Munich	Munich	Bavaria	Germany	81675
4	University of Tuebingen	Tübingen		Germany	72076

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich
Technische Universität München

Investigators

Principal Investigator: 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