Stroke, IschemicNCT06196398
Effects of Medical Treatment of ICAS With Hemodynamic Disorders Based on MR-FFR
An observational study of Stroke, Ischemic and Intracranial Atherosclerosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Ischemic, Intracranial Atherosclerosis
- What is being tested?
- Standard Medical Treatment on the basis of anti-platelet therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Jun 2024
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation.
- 50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTA or MRA.
- mRS 0-2 points
- Informed of the study protocol and objectives.
Who cannot join
- Previous endovascular treatment or surgery for cerebrovascular diseases
- Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI
- Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
- Pregnancy or in the preparation for pregnancy
- Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
- Contraindication for antiplatelet drugs or statins
- Patients with severe dementia or mental disorders, who cannot cooperate with examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
Jichang Luo, luojichang_dr@sina.com
About this study
Official title: 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.
- Conditions
- Stroke, Ischemic, Intracranial Atherosclerosis
- Being tested
- Standard Medical Treatment on the basis of anti-platelet therapy
- Keywords
- Intracranial atherosclerotic diseases, Fractional Flow Reserve, Hemodynamics, Stroke
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical Treatment on the basis of anti-platelet therapyDrug
- 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.
- Intensive statin therapy: Statins with high doses
- Blood pressure: below 140/90mmHg
- LDL: less than 1.81mmol/L(70mg/dl)
- Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%
- Cigarette and alcohol quitting
- Oral anticoagulants for atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Decompensated blood flow reserve | ICAS patients with decompensated cerebral blood flow reserve diagnosed by MR-FFR (FFR baseline≥0.81). Receives: Drug: Standard Medical Treatment on the basis of anti-platelet therapy | |
| Normal blood flow reserve | ICAS patients with normal cerebral blood flow reserve determined by MR-FFR (FFR baseline<0.81). Receives: Drug: Standard Medical Treatment on the basis of anti-platelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of ischemic stroke or death related to the qualifying artery territory
Measured: 1 year
Secondary outcomes (1)
Functional evaluation
Modified Rankin Scale score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196398
- Sponsor's protocol ID
- XWFFR-3
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Medical Treatment of Intracranial Atherosclerotic Diseases Based on Magnetic Resonance Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT06196398
- Acronym / sponsor ID
- XWFFR-3
- Conditions
- Stroke, Ischemic, Intracranial Atherosclerosis
- Keywords
- Intracranial atherosclerotic diseases, Fractional Flow Reserve, Hemodynamics, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Jan 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompensated blood flow reserve | – | Drug: Standard Medical Treatment on the basis of anti-platelet therapyICAS patients with decompensated cerebral blood flow reserve diagnosed by MR-FFR (FFR baseline≥0.81). |
| Normal blood flow reserve | – | Drug: Standard Medical Treatment on the basis of anti-platelet therapyICAS patients with normal cerebral blood flow reserve determined by MR-FFR (FFR baseline<0.81). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation.
- 50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTA or MRA.
- mRS 0-2 points
- Informed of the study protocol and objectives.
Key exclusion criteria (7 listed)
- Previous endovascular treatment or surgery for cerebrovascular diseases
- Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI
- Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
- Pregnancy or in the preparation for pregnancy
- Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
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 |
|---|---|---|
| Standard Medical Treatment on the basis of anti-platelet therapy1. 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 | Drug | Decompensated blood flow reserve, Normal blood flow reserve |
Primary outcome
The composite of ischemic stroke or death related to the qualifying artery territory
Time frame: 1 year
1 secondary outcome
Functional evaluation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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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.
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 Stroke, Ischemic and Intracranial Atherosclerosis, run by Xuanwu Hospital, Beijing 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 4 inclusion and 7 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 9 Jan 2024. 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 Jichang Luo (+8613120136577, luojichang_dr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite of ischemic stroke or death related to the qualifying artery territory (time frame: 1 year). 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 9 Jan 2024.