Trial · NCT04219774

NeuroCognition After Carotid Recanalization

NCT04219774, Phase 2, Completed, Duke University; results first posted 2025-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. NeuroCognition After Carotid Recanalization. Trials, record NCT04219774. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04219774

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: NeuroCognition After Carotid Recanalization
NCT number: NCT04219774
Status: Completed
Phases: Phase 2
Enrollment: 25 participants, actual
Lead sponsor: Duke University
Conditions: Cognition Disorder, Stroke, Occlusion Carotid
Interventions: Endovascular intervention, Aspirin and Clopidogrel (maximal medical Therapy)
First posted: 2020-01-07
Last updated: 2025-05-09
Results first posted: 2025-05-09
Limitations and caveats: The Observation Arm was not included in comparison. It is a non-equivalent group because patients included in the Arm if they were ineligible based on baseline measures and consent to randomization.

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Montreal Cognitive Assessment (MoCA) Score	Baseline, 6 months, 12 months	The MoCA is a screening tool used to assess cognitive function. The possible score range is 0 to 30, with higher scores indicating better cognitive performance.
Primary	Change in Composite Cognitive Score	Baseline, 6 months, 12 months	This outcome reflects overall cognition. The composite z score is based on average z scores for the tests for each subject (sum of the z scores divided by the number of tests included) from a specifically designed battery of 14 cognitive tests: Montreal Cognitive Assessment (MoCA),Wide Range Achievement Test-5 (WRAT-5); Wechsler Adult Intelligence Scale - IV (WAIS-IV); WAIS-IV, Coding subtest; WAIS-IV, Matrix Reasoning subtest; Hopkins Verbal Learning Test; Benton Visual Retention Test (BVRT); Controlled Oral Word Association (COWA) Test; Boston Naming Test; Boston Diagnostic Aphasia Examination, Complex Ideational Material subtest; Trail-Making Test, part A and part B; Beck Depression Inventory-Fast Screen (BDI-FS); Iowa Scales of Personality Change (ISPC). A Z-score of 0 represents no change. Standard deviations above 0 represent better outcomes; standard deviations below 0 represent worse outcomes.
Secondary	Number of Participants With Stroke Within 30 Days Post Procedure	Up to 30 days post procedure
Secondary	Number of Participants With Intracranial Hemorrhage Within 72 Hours Post Procedure	Up to 72 hours post procedure
Secondary	Number of Participant Deaths	Up to 12 months
Other	Change in Mean Transit Time (MTT) on CT Perfusion	Baseline, 12 months	MTT is defined as the average time, in seconds, that circulating blood cells needs to pass within a determinate volume of brain. It is assessed as part of the CT perfusion protocol.
Other	Change in Size of Hippocampus	Baseline, 6 months, 12 months	The change in size of hippocampus in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year.
Other	Change in Size of Amygdala	Baseline, 6 months, 12 months	The change in size of amygdala in the ipsilateral side of COICA (t-test), at enrollment vs. 1 year.
Other	Number of Participants With the Presence of Lactate on 1H-MRI Spectroscopy	Baseline, 6 months, 12 months	Presence of lactate determined by MRI spectroscopy in centrum semiovale in the ipsilateral side of chronic occlusion of the internal carotid artery (COICA).

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Montreal Cognitive Assessment (MoCA) Score	Baseline, 6 months, 12 months	Participants with data collected at both timepoints for each comparison.	score on a scale	MEAN
PRIMARY	Change in Composite Cognitive Score	Baseline, 6 months, 12 months	Participants with data collected at both timepoints for each comparison.	z-score	MEAN
SECONDARY	Number of Participants With Stroke Within 30 Days Post Procedure	Up to 30 days post procedure		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Intracranial Hemorrhage Within 72 Hours Post Procedure	Up to 72 hours post procedure		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participant Deaths	Up to 12 months		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Change in Mean Transit Time (MTT) on CT Perfusion	Baseline, 12 months	Participants with data collected at both timepoints.	seconds	MEAN
OTHER_PRE_SPECIFIED	Change in Size of Hippocampus	Baseline, 6 months, 12 months	Participants with data collected at both timepoints.	cm^3	MEAN
OTHER_PRE_SPECIFIED	Change in Size of Amygdala	Baseline, 6 months, 12 months	Participants with data collected at both timepoints.	cm^3	MEAN
OTHER_PRE_SPECIFIED	Number of Participants With the Presence of Lactate on 1H-MRI Spectroscopy	Baseline, 6 months, 12 months	Participants with data collected at each timepoint.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Montreal Cognitive Assessment (MoCA) Score	Endovascular Arm	Baseline to 6 months	0.56	Standard Deviation 2.70	score on a scale
Change in Montreal Cognitive Assessment (MoCA) Score	Medical Arm	Baseline to 6 months	1.38	Standard Deviation 2.83	score on a scale
Change in Montreal Cognitive Assessment (MoCA) Score	Observational Arm	Baseline to 6 months	-0.75	Standard Deviation 1.71	score on a scale
Change in Montreal Cognitive Assessment (MoCA) Score	Endovascular Arm	Baseline to 12 months	0.50	Standard Deviation 2.20	score on a scale
Change in Montreal Cognitive Assessment (MoCA) Score	Medical Arm	Baseline to 12 months	-0.80	Standard Deviation 2.86	score on a scale
Change in Montreal Cognitive Assessment (MoCA) Score	Observational Arm	Baseline to 12 months	-0.33	Standard Deviation 1.15	score on a scale
Change in Composite Cognitive Score	Endovascular Arm	Baseline to 6 months	0.18	Standard Deviation 0.63	z-score
Change in Composite Cognitive Score	Medical Arm	Baseline to 6 months	-0.005	Standard Deviation 0.65	z-score
Change in Composite Cognitive Score	Observational Arm	Baseline to 6 months	0.065	Standard Deviation 0.88	z-score
Change in Composite Cognitive Score	Endovascular Arm	Baseline to 12 months	0.36	Standard Deviation 0.35	z-score

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Endovascular Arm	12
Overall Study	STARTED	Medical Arm	13
Overall Study	STARTED	Observational Arm	6
Overall Study	6 Weeks Follow-up	Endovascular Arm	6
Overall Study	6 Weeks Follow-up	Medical Arm	0
Overall Study	6 Weeks Follow-up	Observational Arm	6
Overall Study	6 Months Follow-up	Endovascular Arm	7
Overall Study	6 Months Follow-up	Medical Arm	7
Overall Study	6 Months Follow-up	Observational Arm	6
Overall Study	12 Months Follow-up	Endovascular Arm	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events192

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Acute blood loss anemia	Blood and lymphatic system disorders	Endovascular Arm	4	12
other	Acute blood loss anemia	Blood and lymphatic system disorders	Medical Arm	0	13
other	Acute blood loss anemia	Blood and lymphatic system disorders	Observational Arm	0	6
other	Altered mental status	Psychiatric disorders	Endovascular Arm	1	12
other	Altered mental status	Psychiatric disorders	Medical Arm	0	13
other	Altered mental status	Psychiatric disorders	Observational Arm	0	6
other	Atrial Fibrillation	Cardiac disorders	Endovascular Arm	1	12
other	Atrial Fibrillation	Cardiac disorders	Medical Arm	0	13
other	Atrial Fibrillation	Cardiac disorders	Observational Arm	0	6
other	Anemia	Blood and lymphatic system disorders	Endovascular Arm	0	12

1 to 10 of 192Source ClinicalTrials.gov

See all 192 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Endovascular Arm	1	12
Total, all-cause mortality	Medical Arm	1	13
Total, all-cause mortality	Observational Arm	0	6
Total, other adverse events	Endovascular Arm	10	12
Total, other adverse events	Medical Arm	8	13
Total, other adverse events	Observational Arm	4	6
Total, serious adverse events	Endovascular Arm	6	12
Total, serious adverse events	Medical Arm	6	13
Total, serious adverse events	Observational Arm	3	6

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30312821	BACKGROUND	PubMed
30557930	BACKGROUND	PubMed
30925474	BACKGROUND	PubMed
31298301	BACKGROUND	PubMed
31349074	BACKGROUND	PubMed
31872191	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Matrix Reasoning	Primary outcome	ConductCognition
Picture Naming Test	Primary outcome	ConductCognition
Verbal Fluency	Primary outcome	ConductCognition
Verbal Learning	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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