Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke (ENCLOSE)

October 1, 2021 updated by: Jan. W. Dankbaar, MD, PhD, UMC Utrecht

Rationale: Over 20.000 people suffer an ischemic stroke in the Netherlands each year. Large artery occlusions are easy to identify and can be treated with endovascular clot removal. 70% of patient will however suffer from a more distal occlusion resulting in small volume stroke or a transient ischemic attack (TIA). Small ischemic lesions are hard to detect with current acute stroke protocols. TIA and small volume stroke patients, are at an increased risk for recurrent stroke, making immediate diagnosis critical. Because thrombo-embolic sources often cause these strokes, identifying and treating the underlying aetiology has the potential to radically lower the risk of recurrence and improve the outcome of these patients.

Objectives: 1) To identify clinical and imaging predictors of recurrent stroke; 2) To improve early detection of small volume stroke with admission computed tomography perfusion (CTP) in patients with suspected acute ischemic stroke with small volume stroke or no ischemia on admission imaging.

Study design: Prospective, multicenter cohort study.

Study population: All patients who visited the University Medical Center (UMC) Utrecht, the Amsterdam University Medical Centers (Amsterdam UMC), location Academic Medical Center (AMC) or the St. Antonius Hospital and who underwent a CT-scan of the brain within 9 hours after onset of stroke symptoms with an age ≥18 years. Within 36 months, 720 patients will be enrolled in the study. Of these patients, 300 patients will be included for the follow-up magnetic resonance imaging (MRI).

Main study parameters/endpoints: The main study endpoints are: 1) Stroke recurrence rate at 2 years; 2) Presence and volume of acute ischemic lesions on follow-up diffusion weighted imaging MRI.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

720

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 Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • University Medical Center Utrecht
        • Contact:
        • Principal Investigator:
          • Jan W Dankbaar, MD PhD
        • Sub-Investigator:
          • Frans Kauw, MD
        • Sub-Investigator:
          • Richard A.P. Takx, MD PhD
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Not yet recruiting
        • Amsterdam UMC, location AMC
        • Contact:
        • Principal Investigator:
          • Charles B.L.M. Majoie, MD PhD
        • Sub-Investigator:
          • Valeria Guglielmi, MD
        • Sub-Investigator:
          • Jonathan M. Coutinho, MD PhD
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • Not yet recruiting
        • St. Antonius Hospital
        • Contact:
        • Principal Investigator:
          • Wouter van Es, MD PhD

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years or older with acute stroke symptoms who visited the UMC Utrecht, the Amsterdam UMC, location AMC or the St. Antonius Hospital and who underwent a CT-scan within 9 hours after onset of stroke symptoms.

Description

Inclusion Criteria:

  • Age ≥18 years;
  • Time from symptom onset until imaging is <9 hours*;
  • Clinical diagnosis of acute ischemic stroke or TIA;

  • Informed consent from patient or family after the admission scan (unless the patient died).

    • Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours.

Exclusion Criteria:

  • Patients with another diagnosis such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor;
  • Patients with known contrast allergy or renal failure.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent ischemic stroke
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent ischemic stroke
Time Frame: 90 days
90 days
modified Rankin scale
Time Frame: 90 days

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.

9 - No data.
90 days

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Collaborators

Dutch Heart Foundation
Netherlands Organisation for Scientific Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 23, 2018

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL62233.041.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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