Improved Prediction of Recurrent Stroke and Detection of Small Volume Stroke

NCT04019483 | Terminated DMC

• 1 other identifier: NL62233.041.17
• Study Type: observational
• Target: 439
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Recurrence; Infarct detection; CT; MRI; Diagnosis; Prognosis

Outcome Measures

Primary Outcomes (1)

• Recurrent ischemic stroke

  2 years

Secondary Outcomes (2)

• Recurrent ischemic stroke

  90 days

• modified Rankin scale

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch Heart Foundation: collaborator
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (3)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

• Kauw F, Velthuis BK, Takx RAP, Guglielmo M, Cramer MJ, van Ommen F, Bos A, Bennink E, Kappelle LJ, de Jong HWAM, Dankbaar JW. Detection of Cardioembolic Sources With Nongated Cardiac Computed Tomography Angiography in Acute Stroke: Results From the ENCLOSE Study. Stroke. 2023 Mar;54(3):821-830. doi: 10.1161/STROKEAHA.122.041018. Epub 2023 Feb 13.

  PMID: 36779342 DERIVED

• Kauw F, van Ommen F, Bennink E, Cramer MJ, Kappelle LJ, Takx RA, Velthuis BK, Viergever MA, Wouter van Es H, Schonewille WJ, Coutinho JM, Majoie CB, Marquering HA, de Jong HW, Dankbaar JW. Early detection of small volume stroke and thromboembolic sources with computed tomography: Rationale and design of the ENCLOSE study. Eur Stroke J. 2020 Dec;5(4):432-440. doi: 10.1177/2396987320966420. Epub 2020 Oct 23.

  PMID: 33598562 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Recurrence; Disease

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: January 23, 2018
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)