Phase 4
Completed N=11
Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm
Subarachnoid Hemorrhage, Aneurysmal · Vasospasm, Cerebral
Source: ClinicalTrials.gov NCT03377049 ↗
Enrolled (actual)
11
Serious AEs
18.2%
Results posted
Jul 2023
Primary outcomePrimary: Number of Participants Who Develop Delayed Cerebral Vasospasm — 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Develop Delayed Cerebral Vasospasm |
2 | — |
| SECONDARY Relative Percent Change in Cerebral Blood Flow |
20.722 | — |
| SECONDARY Percent Change in Left Hemisphere Brain Imaging Maps |
19.785 | — |
| SECONDARY Percent Change in Right Hemisphere Brain Imaging Maps |
21.659 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03377049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.