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Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm
Phase 4
Waitlist Available
Led By Azam Ahmed, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post perfusion during imaging procedure, up to an hour
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial uses a special CT scan and a drug to check brain blood flow in patients with a specific type of brain bleed. The drug should increase blood flow, and if it doesn't, it indicates a problem. This helps identify patients at risk for future brain issues like stroke.
Eligible Conditions
- Migraine
- Brain Aneurysm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre and post perfusion during imaging procedure, up to an hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre and post perfusion during imaging procedure, up to an hour
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Develop Delayed Cerebral Vasospasm
Secondary study objectives
Percent Change in Left Hemisphere Brain Imaging Maps
Percent Change in Right Hemisphere Brain Imaging Maps
Relative Percent Change in Cerebral Blood Flow
Side effects data
From 2022 Phase 4 trial • 11 Patients • NCT033770499%
External Ventricular Drainage infection
9%
Hydrocephalus
9%
Pulmonary edema
9%
Cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acetazolamide Challenge
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Acetazolamide ChallengeExperimental Treatment1 Intervention
Participants entered into the study as a cohort, will because of their participation, undergo only two additional digital subtraction angiogram (DSA) imaging acquisitions. These will be done in conjunction with their standard diagnostic DSA evaluation and consist of two CBCTPs, one before and one after administration of 1 g acetazolamide through a peripheral IV line. Each CBCTP will require administration of 75-100 mL iodinated contrast medium also through an intravenous line. Neither of these imaging studies will be used for clinical decision making, but would be processed and evaluated at later date for a formal analysis of the results. Following completion of diagnostic imaging subjects will receive the usual standard of care for treatment of their ruptured aneurysm i.e. endovascular embolization or open surgical clipping.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~3030
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,234 Previous Clinical Trials
3,200,280 Total Patients Enrolled
Azam Ahmed, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
100 Total Patients Enrolled