Trial · NCT07894107
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of stroke within 24 months after enrollment | From enrollment through 24 months | Stroke is defined as symptomatic ischemic stroke or intracerebral hemorrhage occurring after enrollment. Suspected stroke events will be identified through scheduled or event-driven follow-up, telephone interviews, and review of hospitalization records and will be confirmed by brain CT or MRI whenever available. The outcome will be reported as the percentage of participants experiencing at least one incident stroke within 24 months after enrollment. |
| Secondary | Incidence of stroke within 6 months after enrollment | From enrollment through 6 months | Stroke is defined as symptomatic ischemic stroke or intracerebral hemorrhage occurring after enrollment and confirmed by clinical records and brain CT or MRI whenever available. The outcome will be reported as the percentage of participants experiencing at least one incident stroke within 6 months after enrollment. |
| Secondary | Incidence of stroke within 12 months after enrollment | From enrollment through 12 months | Stroke is defined as symptomatic ischemic stroke or intracerebral hemorrhage occurring after enrollment and confirmed by clinical records and brain CT or MRI whenever available. The outcome will be reported as the percentage of participants experiencing at least one incident stroke within 12 months after enrollment. |
| Secondary | Incidence of transient ischemic attack within 24 months | From enrollment through 24 months | Transient ischemic attack is defined as an acute focal neurological deficit attributable to cerebral ischemia that completely resolves within 24 hours without evidence of a new cerebral infarction on CT or MRI. The outcome will be reported as the percentage of participants experiencing at least one transient ischemic attack during follow-up. |
| Secondary | Number of transient ischemic attack episodes within 24 months | From enrollment through 24 months | The total number of protocol-defined transient ischemic attack episodes occurring in each participant during follow-up will be recorded. The outcome will be reported as the number of transient ischemic attack episodes per participant. |
| Secondary | Incidence of disabling stroke within 24 months | From enrollment through 24 months | Disabling stroke is defined as an incident stroke associated with a modified Rankin Scale score greater than 1, according to the study protocol. The outcome will be reported as the percentage of participants experiencing a disabling stroke. |
| Secondary | Participants with an increase of at least 1 point in the modified Rankin Scale score at 6 months | Baseline to 6 months | Neurological disability will be assessed using the modified Rankin Scale, which ranges from 0 to 6, with higher scores indicating greater disability. The outcome will be reported as the percentage of participants whose modified Rankin Scale score increases by at least 1 point from baseline. |
| Secondary | Participants with an increase of at least 1 point in the modified Rankin Scale score at 12 months | Baseline to 12 months | Neurological disability will be assessed using the modified Rankin Scale, which ranges from 0 to 6, with higher scores indicating greater disability. The outcome will be reported as the percentage of participants whose modified Rankin Scale score increases by at least 1 point from baseline. |
| Secondary | Participants with an increase of at least 1 point in the modified Rankin Scale score at 24 months | Baseline to 24 months | Neurological disability will be assessed using the modified Rankin Scale, which ranges from 0 to 6, with higher scores indicating greater disability. The outcome will be reported as the percentage of participants whose modified Rankin Scale score increases by at least 1 point from baseline. |
| Secondary | All-cause mortality within 24 months | From enrollment through 24 months | The outcome will be reported as the percentage of participants who die from any cause during follow-up. |
| Secondary | Vascular mortality within 24 months | From enrollment through 24 months | The outcome will be reported as the percentage of participants whose death is adjudicated as being due to a vascular cause during follow-up. |
| Secondary | Change from baseline in Montreal Cognitive Assessment total score at 12 months | Baseline to 12 months | Cognitive function will be assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change will be calculated as the 12-month total score minus the baseline total score. A negative value indicates a decline in cognitive performance. |
| Secondary | Participants with a decrease of at least 1 point in Montreal Cognitive Assessment total score at 12 months | Baseline to 12 months | Cognitive function will be assessed using the Montreal Cognitive Assessment, which ranges from 0 to 30, with higher scores indicating better cognitive performance. Cognitive decline for this outcome is defined as a decrease of at least 1 point in the total score from baseline. The outcome will be reported as the percentage of participants meeting this criterion. |
| Secondary | Change from baseline in Montreal Cognitive Assessment total score at 24 months | Baseline to 24 months | Cognitive function will be assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change will be calculated as the 24-month total score minus the baseline total score. A negative value indicates a decline in cognitive performance. |
| Secondary | Participants with a decrease of at least 1 point in Montreal Cognitive Assessment total score at 24 months | Baseline to 24 months | Cognitive function will be assessed using the Montreal Cognitive Assessment, which ranges from 0 to 30, with higher scores indicating better cognitive performance. Cognitive decline for this outcome is defined as a decrease of at least 1 point in the total score from baseline. The outcome will be reported as the percentage of participants meeting this criterion. |
| Secondary | Disease progression at 12 months | Baseline to 12 months | Disease progression is defined as the presence of at least one prespecified imaging change compared with baseline, including progression of intracranial arterial stenosis or occlusion, reduction in collateral circulation, or deterioration in cerebral perfusion according to the study protocol. The outcome will be reported as the percentage of participants meeting the criteria for disease progression. |
| Secondary | Disease progression at 24 months | Baseline to 24 months | Disease progression is defined as the presence of at least one prespecified imaging change compared with baseline, including progression of intracranial arterial stenosis or occlusion, reduction in collateral circulation, or deterioration in cerebral perfusion according to the study protocol. The outcome will be reported as the percentage of participants meeting the criteria for disease progression. |
| Secondary | Conversion from initial conservative management to cerebral revascularization within 24 months | From enrollment through 24 months | Among participants initially managed conservatively, the outcome is defined as subsequent cerebral revascularization performed during follow-up because surgery is considered clinically necessary. Treatment decisions are made by treating physicians and participants and are not assigned by the study protocol. The outcome will be reported as the percentage of initially conservatively managed participants undergoing cerebral revascularization. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT07894107/registered