Comparing imaging techniques to improve stroke treatment outcomes

Comparison Influence to Prognosis of Computed Tomography Perfusion (CTP) and Magnetic Resonance Perfusion (MRP) in Acute Ischemic Stroke (AIS) Patients

This study is testing whether using different imaging techniques can help doctors find the best treatment for stroke patients who need quick care to improve their recovery.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT03367286 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of computed tomography perfusion (CTP) versus magnetic resonance perfusion (MRP) in identifying acute ischemic stroke (AIS) patients who may benefit from early reperfusion therapy. It will enroll 1000 patients, dividing them into two groups based on the imaging technique available. The study will assess the ability of these imaging methods to predict clinical outcomes after administering thrombolytic therapy beyond the standard treatment window. Key endpoints include measuring the modified Rankin score at three months post-stroke and evaluating secondary outcomes such as symptomatic intracranial hemorrhage and infarct growth.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have experienced an acute ischemic stroke and meet specific imaging criteria for treatment beyond 4.5 hours after symptom onset.

Not a fit: Patients with pre-existing disabilities, contraindications to thrombolytic therapy, or those with terminal illnesses are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the identification of AIS patients eligible for thrombolytic therapy, potentially reducing disability and improving recovery outcomes.

How similar studies have performed: Previous studies have shown success with similar imaging approaches in identifying stroke patients who may benefit from extended treatment windows.

Eligibility criteria

Criteria:

Inclusion Criteria:

1. Provision of informed consent;
2. Male and female adults aged 18-80 years old;
3. For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume \<70mL, perfusion leison volume / infarct core volume \>1.2, and absolute mismatch \>10 mL.

Exclusion Criteria:

1. Standard contraindications to rt-PA;
2. Contraindication to imaging with contrast agents;
3. Pre-stroke mRS score of ≥2 (indicating previous disability);
4. Participation in any investigational study in the previous 30 days;
5. Any terminal illness such that patient would not be expected to survive more than one-year.

Where this trial is running

Hangzhou

• The second affiliated hospital of Zhejiang University — Hangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Min Lou, Ph.D

Conditions: Stroke