Cerebral InfarctionNCT05679986
Early Neurological Deterioration in Recent Small Subcortical Infarction
An observational study of Cerebral Infarction and Subcortical Infarction, run by Yuan Gao at 1 site in China.
Trial summary
Recent small subcortical infarction (RSSI) is defined as a small deep infarction in the territory of a perforating artery with maximum axial diameters (MAD) of less than 20 mm. Although RSSI is generally considered to be of a relatively favorable prognosis, about 13.5% to 43% of RSSI patients experience early… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction, Subcortical Infarction, Deterioration, Clinical
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Jan 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: prospectively enroll consecutive patients with acute RSSI within 72 hours of onset January 2015 to January 2024.
Who may be able to join
- Age ≥ 18 years;
- Time from the last seen normal to enrollment ≤ 72 h.
- Completion of brain MRI (T1/T2/Flair/DWI sequences at least). The lesion belonged to the territory of the penetrating artery( lenticulostriate area and pons) on the DWI sequence and at least one of the vascular examinations such as MRA, CTA or DSA was completed.
Who cannot join
- Patients with low imaging quality affecting the evaluation of the data;
- Vascular malformations, aneurysms, intracranial hemorrhagic diseases, brain abscesses, malignant space occupying lesions or other non-ischemic intracranial lesions;
- Patients with combined malignancy, hematological disease and other systemic diseases with possible hypercoagulable state;
- pre-stroke mRS ≥2 ;
- END occurred before the completion of brain MRI after admission;
- Acute endovascular treatment had been received or was planed to be done;
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- Pregnant or lactating women;
- Participating in another ongoing study;
- Refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yuan Gao, doctor, 13949113087, fccgaoy1@zzu.edu.cn
About this study
Official title: Early Neurological Deterioration in Recent Small Subcortical Infarction：a Prospective Study
Recent small subcortical infarction (RSSI) is defined as a small deep infarction in the territory of a perforating artery with maximum axial diameters (MAD) of less than 20 mm. Although RSSI is generally considered to be of a relatively favorable prognosis, about 13.5% to 43% of RSSI patients experience early neurological deterioration (END) in the acute phase, which often bring adverse effects on long-term outcomes. Although a number of risk factors for END have been identified previously, however, the risk factors of END and the underlying etiological mechanism are still ambiguous, and also the relevant intervention measures lack sufficient evidences, which is a thorny problem that clinicians have to face.
In this multicenter, large-sample prospective registry study, we ought to investigate the natural course of END in patients with RSSI. Exploring the risk factors and potential mechanism of its occurrence and development, and trying to establish a comprehensive predictive model for END that integrates multi-dimensional information including clinical symptom, demographic data, biochemical biomarker and image data, and so as to provide a valuable tool for clinical evaluation and early management. Simultaneously, our study will provide information for the design of therapeutic randomized controlled trials in the future.
Read the detailed description
RSSI patients within 72 hours of stroke onset were prospectively and consecutively enrolled from Janu 2015 to June 2024. After enrollment, Clinical data will be collected using an online electronic case report Form (e-CRF) at baseline and follow-up. Baseline data including demographic, first blood pressure, past and family history, past medications use, pre-stroke modified Rankin Scale score (mRS), assessment of mRS and NIHSS score on admission were recorded. After admission, NIHSS score was evaluated twice a day by two certified physicians, who were blinded to the study. laboratory tests including routine blood/biochemistry/renal function, etc.) Transthoracic echocardiogram, 24-hour Holter and neuroimages data including brain MRI/MRA/CTA/DSA, etc. were all collected. During hospitalization, the drug therapy (antiplatelet/anticoagulation, lipid-lowering, glucose lowering, antihypertensive, etc.) were also recorded. Early neurological deteriorations (END) were monitored by two certified physicians, who were blinded to the imaging, and the primary outcome of our study was the occurrence of END, which was defined as any increase of ≥ 2 points in the total NIHSS score or ≥ 1 point on the motor items of the NIHSS within 7 days of hospital admission with blind evaluation. And any new cerebrovascular events confirmed during hospitalization were recorded. By face-to face or telephone interviews, we extended the follow up to 1 year for our secondary outcome including ①percentage of patients with favorable functional recovery, defined as an mRS ≤1; ②Percentage of patients with new vascular events, defined as any stroke (ischemic or hemorrhage); ③Percentage of patients with the new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually. ④Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage; ⑤ Incidence of symptomatic and asymptomatic intracranial hemorrhagic events; ⑥All-cause mortality; ⑦cognitive function (MOCA/MMSE score). The outcomes will be assessed by the neurologists blinded to study images. The quality control of all data will be held by the central center.
- Being tested
- no intervention
- Keywords
- Early Neurological Deterioration, Recent Small Subcortical Infarction
- Medical subject headings
- Cerebral Infarction, Clinical Deterioration, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Recent small subcortical infarction within 72 hours from stroke onset to admission | Recent small subcortical infarction (RSSI) is defined as small deep infarctions in the territory of perforating arteries with maximum axial diameters (MAD) of less than 20 mm. In this study, RSSIs in the territories of lenticulostriate area, pons are enrolled. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Neurological Deterioration
any increase of ≥ 2 points in the total NIHSS score or ≥ 1 point on the motor items of the NIHSS within 7 days after admission
Measured: within 7 days after admission
Secondary outcomes (6)
Percentage of patients with favorable functional recovery
mRS ≤1
Measured: 12 months
Percentage of patients with new vascular events
any stroke (ischemic or hemorrhage)
Measured: 12 months
Percentage of patients with new clinical vascular events
ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death as a cluster and evaluated individually
Measured: 12 months
Severe bleeding
Severe bleeding incidence (GUSTO definition),including fatal bleeding and symptomatic intracranial hemorrhage.
Measured: 12 months
All-cause mortality
All-cause mortality
Measured: 12 months
cognitive function
MOCA/MMSE score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2015
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yuan Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuan Gao, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yuan Gao, doctor, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679986
- Sponsor's protocol ID
- 2022-KY-1334-002
- Status last verified
- Aug 2023
- First submitted
- 25 Dec 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neurological Deterioration in Recent Small Subcortical Infarction：a Prospective Study
- ClinicalTrials.gov ID
- NCT05679986
- Acronym / sponsor ID
- 2022-KY-1334-002
- Keywords
- Early Neurological Deterioration, Recent Small Subcortical Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yuan GaoUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent small subcortical infarction (RSSI) is defined as a small deep infarction in the territory of a perforating artery with maximum axial diameters (MAD) of less than 20 mm. Although RSSI is generally considered to be of a relatively favorable prognosis, about 13.5% to 43% of RSSI patients experience early neurological deterioration (END) in the acute phase, which often bring adverse effects on long-term outcomes. Although a number of risk factors for END have been identified previously, however, the risk factors of END and the underlying etiological mechanism are still ambiguous, and also the relevant intervention measures lack sufficient evidences, which is a thorny problem that clinicians have to face.
In this multicenter, large-sample prospective registry study, we ought to investigate the natural course of END in patients with RSSI. Exploring the risk factors and potential mechanism of its occurrence and development, and trying to establish a comprehensive predictive model for END that integrates multi-dimensional information including clinical symptom, demographic data, biochemical biomarker and image data, and so as to provide a valuable tool for clinical evaluation and early management. Simultaneously, our study will provide information for the design of therapeutic randomized controlled trials in the future.
Detailed description
RSSI patients within 72 hours of stroke onset were prospectively and consecutively enrolled from Janu 2015 to June 2024. After enrollment, Clinical data will be collected using an online electronic case report Form (e-CRF) at baseline and follow-up. Baseline data including demographic, first blood pressure, past and family history, past medications use, pre-stroke modified Rankin Scale score (mRS), assessment of mRS and NIHSS score on admission were recorded. After admission, NIHSS score was evaluated twice a day by two certified physicians, who were blinded to the study. laboratory tests including routine blood/biochemistry/renal function, etc.) Transthoracic echocardiogram, 24-hour Holter and neuroimages data including brain MRI/MRA/CTA/DSA, etc. were all collected. During hospitalization, the drug therapy (antiplatelet/anticoagulation, lipid-lowering, glucose lowering, antihypertensive, etc.) were also recorded. Early neurological deteriorations (END) were monitored by two certified physicians, who were blinded to the imaging, and the primary outcome of our study was the occurrence of END, which was defined as any increase of ≥ 2 points in the total NIHSS score or ≥ 1 point on the motor items of the NIHSS within 7 days of hospital admission with blind evaluation. And any new cerebrovascular events confirmed during hospitalization were recorded. By face-to face or telephone interviews, we extended the follow up to 1 year for our secondary outcome including ①percentage of patients with favorable functional recovery, defined as an mRS ≤1; ②Percentage of patients with new vascular events, defined as any stroke (ischemic or hemorrhage); ③Percentage of patients with the new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually. ④Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage; ⑤ Incidence of symptomatic and asymptomatic intracranial hemorrhagic events; ⑥All-cause mortality; ⑦cognitive function (MOCA/MMSE score). The outcomes will be assessed by the neurologists blinded to study images. The quality control of all data will be held by the central center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recent small subcortical infarction within 72 hours from stroke onset to admission | – | Other: no interventionRecent small subcortical infarction (RSSI) is defined as small deep infarctions in the territory of perforating arteries with maximum axial diameters (MAD) of less than 20 mm. In this study, RSSIs in the territories of lenticulostriate area, pons are enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prospectively enroll consecutive patients with acute RSSI within 72 hours of onset January 2015 to January 2024.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Time from the last seen normal to enrollment ≤ 72 h.
- Completion of brain MRI (T1/T2/Flair/DWI sequences at least). The lesion belonged to the territory of the penetrating artery( lenticulostriate area and pons) on the DWI sequence and at least one of the vascular examinations such as MRA, CTA or DSA was completed.
Key exclusion criteria (9 listed)
- Patients with low imaging quality affecting the evaluation of the data;
- Vascular malformations, aneurysms, intracranial hemorrhagic diseases, brain abscesses, malignant space occupying lesions or other non-ischemic intracranial lesions;
- Patients with combined malignancy, hematological disease and other systemic diseases with possible hypercoagulable state;
- pre-stroke mRS ≥2 ;
- END occurred before the completion of brain MRI after admission;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Recent small subcortical infarction within 72 hours from stroke onset to admission |
Primary outcome
Early Neurological Deterioration
Time frame: within 7 days after admission
any increase of ≥ 2 points in the total NIHSS score or ≥ 1 point on the motor items of the NIHSS within 7 days after admission
6 secondary outcomes
Percentage of patients with favorable functional recovery
Time frame: 12 months
Percentage of patients with new vascular events
Time frame: 12 months
Percentage of patients with new clinical vascular events
Time frame: 12 months
Severe bleeding
Time frame: 12 months
All-cause mortality
Time frame: 12 months
cognitive function
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Gao, doctor principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction and Subcortical Infarction, run by Yuan Gao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Gao, doctor (13949113087, fccgaoy1@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Neurological Deterioration (time frame: within 7 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.