Trial Outcomes & Findings for Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm (NCT NCT03377049)
NCT ID: NCT03377049
Last Updated: 2023-07-27
Results Overview
Clinical neurological deterioration not attributable to other causes, mores specifically not due to re-bleeding, hydrocephalus, or metabolic changes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
Day 1-14 during the hospitalization
Results posted on
2023-07-27
Participant Flow
Participants were recruited from July 2019 to April 2022.
Participant milestones
| Measure |
Acetazolamide Challenge
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.
Acetazolamide: 1 g acetazolamide through a peripheral IV line
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|---|---|
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Overall Study
STARTED
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11
|
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Overall Study
COMPLETED
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11
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm
Baseline characteristics by cohort
| Measure |
Acetazolamide Challenge
n=11 Participants
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.
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|---|---|
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Age, Customized
30-39 years
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2 Participants
n=5 Participants
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Age, Customized
40-49 years
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0 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
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3 Participants
n=5 Participants
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Age, Customized
60-69 years
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3 Participants
n=5 Participants
|
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Age, Customized
70-79 years
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3 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=5 Participants
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Region of Enrollment
United States
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11 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1-14 during the hospitalizationClinical neurological deterioration not attributable to other causes, mores specifically not due to re-bleeding, hydrocephalus, or metabolic changes.
Outcome measures
| Measure |
Acetazolamide Challenge
n=11 Participants
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.
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|---|---|
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Number of Participants Who Develop Delayed Cerebral Vasospasm
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2 Participants
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SECONDARY outcome
Timeframe: pre and post perfusion during imaging procedure, up to an hourThe data that will be statistically compared is the pre-diamox perfusion in comparison to the post-diamox perfusion. A statistically significant change increase in CBF represents an appropriate response to Diamox. Lack of change in CBF or decrease in CBF could be suggestive of potential for developing vasospasm.
Outcome measures
| Measure |
Acetazolamide Challenge
n=11 Participants
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.
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|---|---|
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Relative Percent Change in Cerebral Blood Flow
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20.722 percent change
Standard Deviation 13.967
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SECONDARY outcome
Timeframe: pre and post perfusion during imaging procedure, up to an hourUsing perfusion map values, relative percent change will be calculated
Outcome measures
| Measure |
Acetazolamide Challenge
n=11 Participants
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.
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|---|---|
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Percent Change in Left Hemisphere Brain Imaging Maps
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19.785 percent change
Standard Deviation 13.488
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SECONDARY outcome
Timeframe: pre and post perfusion during imaging procedure, up to an hourUsing perfusion map values, relative percent change will be calculated
Outcome measures
| Measure |
Acetazolamide Challenge
n=11 Participants
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.
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|---|---|
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Percent Change in Right Hemisphere Brain Imaging Maps
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21.659 percent change
Standard Deviation 15.046
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Adverse Events
Acetazolamide Challenge
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Acetazolamide Challenge
n=11 participants at risk
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.
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|---|---|
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Cardiac disorders
Cardiomyopathy
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9.1%
1/11 • Number of events 1 • Days 1-14 during hospitalization
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Nervous system disorders
External Ventricular Drainage infection
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9.1%
1/11 • Number of events 1 • Days 1-14 during hospitalization
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Nervous system disorders
Hydrocephalus
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9.1%
1/11 • Number of events 1 • Days 1-14 during hospitalization
|
Other adverse events
| Measure |
Acetazolamide Challenge
n=11 participants at risk
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.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Pulmonary edema
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9.1%
1/11 • Number of events 1 • Days 1-14 during hospitalization
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Additional Information
Azam Ahmed, MD, FAANS, FACS
UW School of Medicine and Public Health
Phone: 608-263-0485
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place