Early Neurological Deterioration in Recent Small Subcortical Infarction

August 30, 2023 updated by: Yuan Gao

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

prospectively enroll consecutive patients with acute RSSI within 72 hours of onset January 2015 to January 2024.

Description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Time from the last seen normal to enrollment ≤ 72 h.
  3. 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.

Exclusion Criteria:

  1. Patients with low imaging quality affecting the evaluation of the data;
  2. Vascular malformations, aneurysms, intracranial hemorrhagic diseases, brain abscesses, malignant space occupying lesions or other non-ischemic intracranial lesions;
  3. Patients with combined malignancy, hematological disease and other systemic diseases with possible hypercoagulable state;
  4. pre-stroke mRS ≥2 ;
  5. END occurred before the completion of brain MRI after admission;
  6. Acute endovascular treatment had been received or was planed to be done;
  7. Pregnant or lactating women;
  8. Participating in another ongoing study;
  9. Refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 7 days after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with favorable functional recovery
Time Frame: 12 months
mRS ≤1
12 months
Percentage of patients with new vascular events
Time Frame: 12 months
any stroke (ischemic or hemorrhage)
12 months
Percentage of patients with new clinical vascular events
Time Frame: 12 months
ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death as a cluster and evaluated individually
12 months
Severe bleeding
Time Frame: 12 months
Severe bleeding incidence (GUSTO definition),including fatal bleeding and symptomatic intracranial hemorrhage.
12 months
All-cause mortality
Time Frame: 12 months
All-cause mortality
12 months
cognitive function
Time Frame: 12 months
MOCA/MMSE score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuan Gao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuan Gao, doctor, The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-KY-1334-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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