Overview
Perfusion and Antihypertensive Therapy in Acute Ischemic Stroke
Status:
Completed
Completed
Trial end date:
2015-08-01
2015-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to provide a description of blood flow changes in the brain after blood pressure lowering drugs are given. This information will be used by physicians to guide blood pressure lowering therapy in stroke patients in the future.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of AlbertaTreatments:
Antihypertensive Agents
Labetalol
Nitroglycerin
Criteria
Inclusion Criteria:- Acute ischemic stroke within 72 hours of symptom onset. In cases where onset time can
not be established, it will be considered to be the time when the patient was last
known to be well.
- 18 years or older.
- Patients with Partial Anterior Circulation Infarcts (PACI; Oxfordshire Stroke
Classification Project; OSCP) will be included.
- Patients with Posterior Circulation Infarcts (POCI) will be included only if there is
evidence of cortical infarction in the territory of the posterior cerebral artery or
its branches, including the occipital and mesial temporal lobes.
Exclusion Criteria:
- Patients with a contraindication to the BP lowering protocol (i.e. known
extracranial/intracranial arterial stenosis, high-grade stenotic valvular heart
disease, or severe renal failure) will be ineligible, as will those with a definite
indication for BP reduction (i.e. hypertensive encephalopathy, or aortic dissection).
- Patients with contraindications to MRI will be excluded, including metallic implants
and any past sensitivity to gadolinium contrast media.
- Due to recent reports of nephrogenic systemic fibrosis associated with gadolinium
exposure in individuals with pre-existing renal failure, patients with Creatinine >
160 μmol/l or Glomerular Filtration Rate (GFR) <60 ml/min will also be excluded.
- Patients with renal artery stenosis will be excluded from this study, irrespective of
renal function.
- Due to the possibility that oxygen therapy may confound CBF measurements, patients
requiring >4 lpm to keep Sp02 ≥92% by nasal cannulae will be excluded.
- Patients with a suspected hemodynamic stroke mechanism will be ineligible. This will
include patients with known or suspected hypotensive periods and/or a watershed
territory of cerebral infarction seen on CT or MRI.
- Due to the possibility of increased susceptibility to BP reduction in patients with
raised intracerebral pressure (ICP), those with evidence of significant mass effect
secondary to acute infarction, including any degree of midline shift and/or
ventricular compression will be ineligible. For the same reason, patients with head
and eye deviation or other clinical evidence of a Total Anterior Circulation Infarct
(TACI; OSCP) will also be ineligible.
- Due to technical difficulties associated with PWI in the posterior fossa, patients
with brainstem and cerebellar strokes will be excluded.
- Patients with known sensitivity to nitroglycerin/labetalol/adhesives in nitroglycerin
patches/ACE inhibitors/Angiotensin Receptor Blockers will be excluded.
- Amplification of the vasodilatory effects of topical nitroglycerin by
phosphodiesterase inhibitors such as sildenafil or tadalafil can result in severe
hypotension. Patients who have used either of these drugs within 12 h of initial
assessment will therefore be excluded.