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:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01240356
Eligibility Criteria:
INCLUSION CRITERIA:
Phase I Safety (healthy volunteers):
* Presence of temporal windows as measured first by an FDA-approved diagnostic TCD device.
* Age ≥ 18 years old.
* Signed informed consent.
Phase II (0-3 hours ischemic stroke patients):
* Disabling focal neurological deficit (NIHSS \> 4 points);
* No evidence of hemorrhage on non-contrast head CT scan;
* Intravenous rt-PA (0.9 mg/kg, 10% bolus 90% infusion over 1 hour, maximum dose 90 mg) infusion initiated within 3 hours of symptom onset;
* Diagnostic TCD completed and HF-TCD placed before rt-PA bolus.
* Diagnostic TCD confirms intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery.
* Age ≥ 18 years old.
* Signed informed consent.
Phase II (3-6 hours ischemic stroke patients):
* Measurable focal neurological deficit (NIHSS \> 4 points);
* No evidence of hemorrhage on non-contrast head CT scan;
* Diagnostic TCD confirms intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery.
* Presence of neuroimaging defined mismatch (CT or MRI prior to enrollment)
1. CT-perfusion
* ≥ 20% difference between affected territories on Time to Peak (TTP) and Cerebral Blood Volume (CBV) maps.
2. MRI Diffusion-Perfusion mismatch
* ≥ 20% difference between diffusion-weighted imaging (DWI) lesion and territory of perfusion delay perfusion weighted imaging (PWI).
* Age ≥ 18 years old.
* Signed informed consent.
EXCLUSION CRITERIA:
Phase I Safety (healthy volunteers):
* History of any neurological disease affecting the central nervous system;
* Lack of temporal windows.
* History of renal disease or glomerular filtration rate (GFR) \< 60.
* Contraindication to MRI (e.g., pacemaker, spinal cord stimulator, severe claustrophobia)
Phase II (0-3 hours ischemic stroke patients):
* Absent temporal windows in patients with anterior circulation ischemia;
* Intra-arterial thrombolysis;
* Patient refusal to give informed consent to participate in the CLOTBUST-HF trial;
* Contraindications for intravenous rt-PA (NINDS rt-PA Stroke Study Protocol)2.
* Phase II (3-6 hours ischemic stroke patients):
* Absent temporal windows in patients with anterior circulation ischemia;
* Intra-arterial thrombolysis;
* Patient refusal to give informed consent to participate in the CLOTBUST-HF trial;
* History of allergic response to Definity® microspheres or microbubbles currently being tested (MRX-801);
* Baseline imaging consistent with a malignant ischemic pattern (low CBV values or DWI territory \>100cc of tissue);
* Baseline MRI imaging demonstrating delayed perfusion of \> 8 seconds in \>100cc of brain parenchyma26;
* Patients receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment;
* Significant concurrent medical/neurological conditions or deviation from normal laboratory test values at baseline that, in the opinion of the investigator, pose significant risk to the patient and warrant exclusion from the study;
* Known severe chronic obstructive pulmonary disease (COPD) (baseline oxygen saturation \< 80% on room air);
* Known right-to-left cardiac shunt.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01240356
Study Brief:
Protocol Section:
NCT01240356