Effects of Medical Treatment of ICAS With Hemodynamic Disorders Based on MR-FFR

December 25, 2023 updated by: Xuanwu Hospital, Beijing

Effects of Medical Treatment of Intracranial Atherosclerotic Diseases Based on Magnetic Resonance Fractional Flow Reserve

This multicenter prospective cohort study aims to compare the difference in the effects of medical treatment within 1 year between the two groups of ICAS patients divided hemodynamically by Magnetic Resonance Fractional Flow Reserve. PC MRA will be applied for FFR measurement. The primary outcome is the composite of ischemic stroke or death related to the qualifying artery territory for 1 year.

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.

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.
400

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
    • Beijing
      • Beijing, Beijing, China

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic, moderate to severe stenosis of major arteries in intracranial anterior circulation. The stenosis degree is ≥ 50%, confirmed by imaging evidence, according to modified WASID criteria.

Description

Inclusion Criteria:

  1. Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation.
  2. 50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTA or MRA.
  3. mRS 0-2 points
  4. Informed of the study protocol and objectives.

Exclusion Criteria:

  1. Previous endovascular treatment or surgery for cerebrovascular diseases
  2. Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI
  3. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
  4. Pregnancy or in the preparation for pregnancy
  5. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
  6. Contraindication for antiplatelet drugs or statins
  7. Patients with severe dementia or mental disorders, who cannot cooperate with examination

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

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.
Decompensated blood flow reserve
ICAS patients with decompensated cerebral blood flow reserve diagnosed by MR-FFR (FFR baseline≥0.81).
Drug: Standard Medical Treatment on the basis of anti-platelet therapy
  1. Anti-platelet therapy: aspirin 75mg+clopidogrel 100mg will be applied for patients with severe ICAS stenosis (70%-90%) suffering stroke or TIA within 30 days. After 90 days, single anti-platelet therapy will be continued.
  2. Intensive statin therapy: Statins with high doses
  3. Blood pressure: below 140/90mmHg
  4. LDL: less than 1.81mmol/L(70mg/dl)
  5. Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%
  6. Cigarette and alcohol quitting
  7. Oral anticoagulants for atrial fibrillation
Normal blood flow reserve
ICAS patients with normal cerebral blood flow reserve determined by MR-FFR (FFR baseline<0.81).
Drug: Standard Medical Treatment on the basis of anti-platelet therapy
  1. Anti-platelet therapy: aspirin 75mg+clopidogrel 100mg will be applied for patients with severe ICAS stenosis (70%-90%) suffering stroke or TIA within 30 days. After 90 days, single anti-platelet therapy will be continued.
  2. Intensive statin therapy: Statins with high doses
  3. Blood pressure: below 140/90mmHg
  4. LDL: less than 1.81mmol/L(70mg/dl)
  5. Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%
  6. Cigarette and alcohol quitting
  7. Oral anticoagulants for atrial fibrillation

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
Time Frame
The composite of ischemic stroke or death related to the qualifying artery territory
Time Frame: 1 year
1 year

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
Functional evaluation
Time Frame: 1 year
Modified Rankin Scale score
1 year

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.
Xuanwu Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Key Research and Development Project, China

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, 2023

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.
June 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.
June 1, 2024

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, 2023

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, 2023

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 9, 2024

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.
January 9, 2024

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.
December 25, 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.
December 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.
  • XWFFR-3

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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