Trial Outcomes & Findings for Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients (NCT NCT01419275)

Results Overview

Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

126 participants

Primary outcome timeframe

performed one time within 1 week prior to surgery

Results posted on

2017-08-30

Participant Flow

Enrollment was closed prior to any enrollment in the acute stroke, healthy participant, and diagnosis unspecified groups, so results are presented for the Moyamoya group only.

Participant milestones

Participant milestones
Measure	Moyamoya Participants with Moyamoya disease received arterial spin label magnetic resonance imaging (MRI) with xenon contrast agent.
Overall Study STARTED	126
Overall Study COMPLETED	126
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moyamoya n=126 Participants Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
Age, Continuous	41.3 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment United States	126 participants n=5 Participants

PRIMARY outcome

Timeframe: performed one time within 1 week prior to surgery

Population: One participant did not undergo MRI and was not included in the analysis.

Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.

Outcome measures

Outcome measures
Measure	Moyamoya n=2500 Cerebral regions Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity) Sensitivity	81.7 percentage of regions Interval 79.3 to 84.0
Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity) Specificity	88.9 percentage of regions Interval 86.6 to 90.8

Adverse Events

Moyamoya

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Greg Zaharchuk

Stanford University

Phone: 650-736-6172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place