Expedite and facilitate diagnostic work up of transient ischemic attack and minor ischemic stroke: dynamic 320-detector row CT angiography of cardiac and carotid sources of emboli compared to currrently used diagnostic procedures

Expedite and facilitate diagnostic work up of transient ischemic attack and minor ischemic stroke: dynamic 320-detector row CT angiography of cardiac and carotid sources of emboli compared to currrently used diagnostic procedures - Evaluation of TIA / ischemic stroke with 320-detector row volume CT scanner

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43919

Enrollment

200

Registered

2011-03-08

Start date

2011-12-30

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TIA / ischemic stroke

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients who visit our TIA/IS out-patient clinic within 72 hours after the TIA or IS will be registered. Patients who meet the inclusion criteria will be invited to participate in this study. A total of 200 consecutive patients will be included in this study. Appr. 4 to 5 patients visit our TIA/IS out-patient clinic per week: we expect to require an inclusion period of appr. 1.5 to 2 years. Specific inclusion criteria: 1. Age > 50 years 2. Voluntary participation 3. Having given their written informed consent 4. Willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data.

Exclusion criteria

Exclusion criteria: 1. Age * 50 years 2. Allergy to intravenous application of iodinated contrast media 3. Glomerular filtration rate (GFR) of less than 50 mL/min. 4. Patients with a different diagnosis (intracerebral hemorrhage or stroke mimics) 5. Patients arriving > 72 hours after symptom onset

Design outcomes

Primary

Measure	Time frame
o TTE/TEE and cardiac CT images: The prevalence of minor and major cardioembolic sources as identified by cardiac CTA will be determined and compared to the prevalence as found by TTE/TEE. False positive, false negative, positive and negative predictive value of the 320-detector row volume CT scanner for detection of cardiac and aortic sources of emboli will be evaluated. Main study parameter will be presence of intra-cardiac thrombus. Secondary study parameters are anatomical abnormalities, presence and extent of atherosclerotic plaque in the thoracic aorta and ventricular function. For ventricular functional analysis, the end-diastolic volume, end-systolic volume and ejection fraction will be calculated with use of reconstructed axial image series every 5% of the R-R interval. o Carotid ultrasound and CTA carotid arteries: accuracy of CT angiography of carotid arteries for degree of carotid stenosis (> 50% (males) and > 70% (females)) will be evaluated (in comparison with carotid ultrasound scanning). Main study parameter will be degree of stenosis. Degree of carotid stenosis will be calculated according to the North American Symptomatic Carotid Endarterectomy Trial (NASCET) (25). For carotid ultrasound, a carotid index (peak internal carotid artery velocity (m/s) / peak common carotid artery velocity (m/s)) of will be used to define degree of stenosis. Peak systolic velocity and end-diastolic velocity will be used to confirm degree of stenosis. For CT angiography, degree of cross-sectional stenosis will be calculated in percent as: percent stenosis = (1-dmin/dnorm) x 100%, according to NASCET criteria). o CT angiography intracranial vessels/whole brain CT perfusion: Occurrence of intracranial vessel stenosis will be assessed. Further, degree of stenosis will be assessed in 15 prespecified large intracranial arterial segments per study (Samuels et al. 643-46). Determination of percent stenosis will be calculated using the method for the	—

Measure

Time frame

o TTE/TEE and cardiac CT images: The prevalence of minor and major cardioembolic sources as identified by cardiac CTA will be determined and compared to the prevalence as found by TTE/TEE. False positive, false negative, positive and negative predictive value of the 320-detector row volume CT scanner for detection of cardiac and aortic sources of emboli will be evaluated. Main study parameter will be presence of intra-cardiac thrombus. Secondary study parameters are anatomical abnormalities, presence and extent of atherosclerotic plaque in the thoracic aorta and ventricular function. For ventricular functional analysis, the end-diastolic volume, end-systolic volume and ejection fraction will be calculated with use of reconstructed axial image series every 5% of the R-R interval. o Carotid ultrasound and CTA carotid arteries: accuracy of CT angiography of carotid arteries for degree of carotid stenosis (> 50% (males) and > 70% (females)) will be evaluated (in comparison with carotid ultrasound scanning). Main study parameter will be degree of stenosis. Degree of carotid stenosis will be calculated according to the North American Symptomatic Carotid Endarterectomy Trial (NASCET) (25). For carotid ultrasound, a carotid index (peak internal carotid artery velocity (m/s) / peak common carotid artery velocity (m/s)) of will be used to define degree of stenosis. Peak systolic velocity and end-diastolic velocity will be used to confirm degree of stenosis. For CT angiography, degree of cross-sectional stenosis will be calculated in percent as: percent stenosis = (1-dmin/dnorm) x 100%, according to NASCET criteria). o CT angiography intracranial vessels/whole brain CT perfusion: Occurrence of intracranial vessel stenosis will be assessed. Further, degree of stenosis will be assessed in 15 prespecified large intracranial arterial segments per study (Samuels et al. 643-46). Determination of percent stenosis will be calculated using the method for the

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Secondary

Measure	Time frame
see primary study parameters/outcome of the study	—

Countries

Netherlands

Outcome results