Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

An open label, prospective, single center, pilot trial to assess feasibility and tolerability of short term blood pressure augmentation to minimize infarct progression in acute LVO stroke patients undergoing endovascular therapy.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Norepinephrine; Oxymetazoline; Phenylephrine; Synephrine

Criteria

Inclusion Criteria:

1. Age is ≥18 years

2. Patients presenting with anterior circulation acute ischemic stroke

3. Enrollment within 24 hours of stroke onset

4. Treatment with endovascular thrombectomy

5. Arterial occlusion on CTA or MRA of the ICA, M1 or M2

6. Mismatch - Using CT or MRI with a Tmax >6 second delay perfusion volume and either CT-rCBF or DWI infarct core volume.

1. Mismatch ratio of greater than 1.8, and

2. Absolute mismatch volume of greater than 15 ml, and

3. Infarct core lesion volume of less than 70 mL

Exclusion Criteria:

1. Baseline SBP>200 mm Hg

2. Intracranial hemorrhage (ICH) identified by CT or MRI

3. Inability to access the cerebral vasculature in the opinion of the neurointerventional team

4. Contraindication to imaging with MR

5. A history of a left ventricular heart failure (NYHA Class ≥ III, or EF < 50%) or angina (either unstable or CCS Grade II) involving symptoms at rest or with ordinary physical activity

6. Acute myocardial infarction in the past 6 months

7. Signs or symptoms of acute myocardial infarction, including electrocardiogram find-ings, on admission

8. Elevated serum troponin concentration on admission (>0.1 μg/L)

9. Suspicion of aortic dissection on admission

10. Participation in any investigational study in the previous 30 days

11. Treatment with Monoamine oxidase inhibitors (MAO-I) within last 7 days