NCT07534319 Investigation of Brain Blood Flow Changes in Acute Ischemic Stroke Patients After Successful Endovascular Thrombectomy
| NCT ID | NCT07534319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Acute Cerebrovascular Accident |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-06-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Endovascular thrombectomy (EVT) is an effective treatment strategy to mitigate the ischemic tissue damage caused by the acute cerebral large-vessel occlusion. However, in clinical practice, nearly half of the patients do not experience adequate neurological improvement despite successful recanalization - a phenomenon termed reperfusion failure or clinically ineffective reperfusion. Given the clinical relevance of this phenomenon and the absence of a standardized imaging diagnostic method to identify it, our project aims to explore the potential role of blood oxygenation-level dependent cerebrovascular reactivity (BOLD-CVR) as novel imaging biomarker for studying reperfusion failure. Study population: Adult patients with acute ischemic stroke of the ICA, MCA or with tandem occlusion who have undergone a successful recanalization, described as mTICI score ≥2b. Objective(s): Primary objective: to longitudinally observe blood flow changes derived from BOLD-CVR imaging following successful endovascular thrombectomy in patients with large-vessel occlusion acute ischemic stroke (LVO-AIS) during the early post-treatment phase and assess their association with clinical outcome 90 days post-EVT. Secondary objective: to compare BOLD-CVR findings with those obtained from the clinical standard dynamic susceptibility contrast (DSC) MR perfusion imaging acquired in the same examination session as well as other imaging techniques included in the standard post-treatment imaging protocol at our institution. Outcomes: Clinical outcomes: * 90-day functional outcome. * Functional outcome at hospital discharge. * Neurological deterioration during hospitalization. * Radiologically confirmed haemorrhagic transformation within the reperfused tissue. * Radiologically confirmed infarct lesion progression within the reperfused tissue. * Additionally, DSC MR perfusion imaging parameters and other standard hemodynamic imaging parameters will be considered as imaging outcomes Study design: Single-center prospective observational cohort study Measurements and procedures: Included patients will undergo a total of 3 BOLD-CVR examinations: 72 hours, 7 days, and 90 days after EVT. Participation in the final examination will mark the end of the subject's involvement in the study. Clinical outcomes will be prospectively collected as per established institutional patient management protocols: during hospitalization, at discharge, and at the cerebrovascular outpatient clinic at 3 months. Number of Participants: Target sample size: 100 patients Given the observational study design and exploratory nature of this project, no sample size calculation can be performed. The provided target sample size (N = 100) has been estimated considering the inclusion of as many consecutive subjects as possible. Study period: 2.5 years The investigators aim to enroll a target sample size of 100 patients over a period of 2.5 years. This translates to an inclusion of 3-4 patients per month, with the last three months allocated for the follow-up of the last included patients. Study Centre: Clinical Neuroscience Center, Department of Neurosurgery, University Hospital Zurich Statistical Considerations: The association between BOLD-CVR findings and clinical outcomes will be investigated using regression analyses.
Eligibility Criteria
Inclusion Criteria: * Male and female subjects \>18 years old. * Acute ischemic stroke related to a new occlusion of the internal carotid artery, middle cerebral artery (M1- and/or M2-segment), or both. * Eligibility and performance of endovascular thrombectomy. * Achievement of successful recanalization, defined as mTICI score ≥2b * Written informed consent of the patient or when the patient is not able to participate in the consenting procedure, the written authorization of a family member. Foreign speaking patients should be included by a person with sufficient German language proficiency to act as a translator. Exclusion Criteria: * Documented evidence or a confirmed willingness of the patient not to participate in any scientific study. * Standard contraindications for MRI, such as pacemaker, metallic prothesis, glaucoma, metallic tattoo dyes, verbal confirmed pregnancy. Unwilling or unable to cooperate with breathing manoeuvres. * Major cardiopulmonary diseases, such as severe uncontrolled asthma bronchiale, severe chronic obstructive lung disease (i.e., GOLD stage ≥III), diffuse interstitial lung disease, pulmonary embolism, acute/subacute myocardial infarction, or severe heart failure (i.e., NYHA class ≥III). * Symptomatic increased intracranial pressure. * Presence of intracranial haemorrhage type ≥2 according to the Heidelberg classification. * New onset of seizure.
Contact & Investigator
Jorn Fierstra, Prof Dr. med., PhD
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT07534319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Cerebrovascular Accident. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07534319 currently recruiting?
Yes, NCT07534319 is actively recruiting participants. Contact the research team at meltem.goenel@usz.ch for enrollment information.
Where is the NCT07534319 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT07534319 clinical trial?
NCT07534319 is sponsored by University of Zurich. The principal investigator is Jorn Fierstra, Prof Dr. med., PhD at University of Zurich. The trial plans to enroll 100 participants.