Clinical trial
C-arm Cone Beam CTA and CTP With Acetazolamide Challenge in Aneurysmal Subarachnoid Hemorrhage: Evaluating Predictability for Early Ischemia in Cerebral Vasospasm
Name
2017-1510
Description
The investigators propose a technique using cone beam CT perfusion (CBCTP) imaging with an acetazolamide challenge as a potential diagnostic tool to detect a defect in cerebral autoregulation at a time when it has not yet caused clinically apparent signs or symptoms. 30 participants will be enrolled at the University of Wisconsin - Madison and can expect to be on study for about 2 weeks.
Trial arms
Trial start
2019-07-28
Estimated PCD
2022-07-15
Trial end
2022-07-15
Status
Completed
Phase
Early phase I
Treatment
Acetazolamide
1 g acetazolamide through a peripheral IV line
Arms:
Acetazolamide Challenge
Other names:
Diamox
Size
11
Primary endpoint
Number of Participants Who Develop Delayed Cerebral Vasospasm
Day 1-14 during the hospitalization
Eligibility criteria
Inclusion Criteria:
* Patients with aneurysmal subarachnoid hemorrhage presenting to our institution within 24 hours of symptom onset
* Adults, 18 years of age or older
* Women of childbearing potential must not be pregnant (negative urine pregnancy test)
Exclusion Criteria:
* Contraindication to acetazolamide (i.e. sulfonamide allergy, renal or liver failure)
* Contraindication to contrast media (Allergy or abnormal serum Cr and/or GFR based on current UW guidelines for IV contrast)
* Renal insufficiency, history of renal failure or renal transplant
* Hunt and Hess grade 1 and 5 (Attached protocol provides details on the grading scale. Grade 1 have lowest yield for vasospasm and Grade 5 are by definition critically ill and unstable patients)
* Critically ill patients who are unstable and who cannot undergo scans within the proposed timeline i.e. within 24 hours of the onset of their symptoms.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}
Updated at
2023-07-27
1 organization
1 product
4 indications
Organization
University of Wisconsin, MadisonProduct
AcetazolamideIndication
Subarachnoid HemorrhageIndication
AneurysmIndication
vasospasmIndication
Cerebral