Status:
COMPLETED
CLOTBUST Hands-Free: A Phase I/II Pilot Safety Trial
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke patients. If found to be sa...
Detailed Description
Ultrasound energy to enhance intravenous rt-PA thrombolysis is a promising novel treatment modality for ischemic stroke. Despite encouraging safety data utilizing diagnostic frequencies of transcrania...
Eligibility Criteria
Inclusion
- 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)
- CT-perfusion
- ≥ 20% difference between affected territories on Time to Peak (TTP) and Cerebral Blood Volume (CBV) maps.
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01240356
Start Date
December 1 2008
End Date
October 1 2013
Last Update
May 23 2016
Active Locations (2)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
2
UT Medical School-Houston
Houston, Texas, United States, 77030