Diagnostic Accuracy for Hemodynamically ICAS of MR-FFR Comparing With Pressure-wire-based FFR.

April 25, 2023 updated by: Xuanwu Hospital, Beijing

Diagnostic Accuracy for Hemodynamical Intracranial Atherosclerotic Diseases (ICAS) of Magnetic-Resonance-based Fractional Flow Reserve (MR-FFR) Comparing With Pressure-wire-based FFR.

The aim of this study was to determine the diagnostic accuracy of MR-FFR to detect functionally significant ICAS comparing with pressure-wire-based FFR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will perform a head-to-head comparison between MR-FFR and pressure-wire-based FFR in patients with ICAS. Pressure-wire-based FFR will be used as the gold standard for intravascular pressure gradient measurement. The efficacy and safety of non-invasive FFR will be assessed in this study.

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Xuanwu Hospital, Capital Medical University

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic ICAS resorting to endovascular therapy in our center were recruited consecutively.

Description

Inclusion Criteria:

  1. Patients aged 18 years or older.
  2. Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (intracranial internal carotid artery and their major branches).
  3. 50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
  4. Informed of the study protocol and objectives.

Exclusion Criteria:

  1. Non-atherosclerotic MCA stenosis
  2. Combined with moderate or severe stenosis of other extracranial and intracranial arteries
  3. Previous endovascular treatment or surgery for cerebrovascular diseases
  4. Large cerebral infarction (more than 1/2 MCA perfusion area)
  5. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
  6. Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention
  7. Liver and kidney dysfunction, or severe allergy to the contrast agent
  8. Severe coagulation dysfunction
  9. Pregnancy or in the preparation for pregnancy
  10. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
  11. 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enrolled
Participants with ICAS will be scheduled for both MR screening and pressure-wire-based FFR measurement.
Diagnostic test: MR screening
This study is to compare the results of MR-FFR with pressure-wired-based FFR measurement.
Other Names:
  • Pressure-wire-based FFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of MR-FFR measurement.
Time Frame: 3 days
The consistency of the two groups in the interpretation of hemodynamic conditions across the ICAS lesion.
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of all-cause stroke and mortality.
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Xuanwu Hospital, Beijing

Collaborators

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)

June 18, 2019

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XWFFR-2

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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