Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT02121028
Eligibility Criteria:
Inclusion Criteria:
1. Stroke defined as symptoms lasting \>24 hours and associated with imaging evidence of acute ischemia in the distribution of the stenotic vessel on CT or MRI.
2. Eligible TIA defined as transient neurological symptoms lasting \<24 hours, need to be:
1. accompanied by DWI abnormalities in the distribution of the stenotic artery; or
2. multiple (≥2), stereotyped events associated with unequivocal ischemic symptoms (weakness, aphasia), and attributed to the symptomatic artery.
3. IAD should involve the intracranial carotid, middle cerebral, intracranial vertebral or basilar arteries.
4. Stenosis 50-99% quantified by digital subtraction angiography (DSA), CT angiography-CTA or MR angiography-MRA tests. DSA is not required but will be used if obtained as part of clinical care.
The criteria for 50-99% are:
1. CTA or DSA: measured 50-99% stenosis by WASID criteria (percent stenosis = (1-\[diameter stenosis/diameter normal\]) x 100%.
2. MRA: measured 50-99% stenosis or presence of a flow gap.
5. Age \>30; those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).
6. Enrollment within 21 days of symptom onset and completion of study imaging tests within 21 days of index event (stroke or TIA).
7. Provide informed consent for participation in the study.
Exclusion Criteria:
1. Other cause for stroke: atrial fibrillation, acute anterior wall ST-elevation myocardial infarction \<30days, mitral stenosis, mechanical valve, intracardiac thrombus or vegetation, dilated cardiomyopathy or ejection fraction \<30%, proximal extracranial carotid or vertebral stenosis \>50%.
2. Contraindications to MRI, including MR-incompatible metallic implants, implanted electronic devices, other potentially mobile ferromagnetic material, pregnancy (women in fertile age should have a negative pregnancy test), lactation, morbid obesity, and severe claustrophobia.
3. Renal impairment defined as either a creatinine level \>1.5 mg/dL or a glomerular filtration rate (GFR) \<30 mL/min/1.73 m2.
4. Known allergy to gadolinium.
5. Unable to obtain informed consent by patient or legally authorized representative.
6. Severe behavioral or social problems that may interfere with the conduct of the study.
7. In the investigator's opinion, patient unlikely return for follow up visit and to complete the study.
8. Participation in a drug or device clinical trial within the last 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
99 Years
Study:
NCT02121028
Study Brief:
Protocol Section:
NCT02121028