Clinical Research Projects

TEMPO- 2 (TNK-tPA evaluation for minor ischemic stroke with proven occlusion)

TEMPO-2 is a phase 3, open-label randomized control trial of thrombolysis using TNK-tPA among patients with minor stroke or TIA with mild deficits (NIHSS 0-5) within 12 hours of onset, proven intracranial arterial occlusion and pre-stroke independent functional status will be treated within 90 minutes of baseline CT imaging and intravenous TNK-tPA at a single dose of 0.25 mg/kg. The primary outcome will be complete functional recovery (modified Rankin Scale score 0-1) at 90 days. Secondary outcomes  will be safety and arterial recanalization. Baseline, treatment and outcome data will be collected in clinical routine in the registry.

DATAS-2 (Dabigatran treatment following TIA and minor stroke)

DATAS-2 is a randomized, controlled trial comparing 30 days of dabigatran to best standard of care antiplatelet therapy. Up to 1000 patients with minor stroke without intracranial occlusion confirmed on MR imaging will be randomized at multiple centres in Alberta. The primary outcome will be functional recovery (modified Rankin Scale score 0-1) at 30 days. Baseline, treatment and outcome data will be collected in clinical routine in the registry.

PER DIEM (Post-Embolic Rhythm Detection with Implatable versus External Monitoring)

PER DIEM is a randomized, controlled trial comparing ELR (external loop recorder) to ILR (implanted loop recorder) ECG monitoring in non-cryptogenic stroke.  PER DIEM will randomize (1:1) 300 TIA/stroke patients in Edmonton and Calgary without known AF to 30 days monitoring with an ELR (Sorin SpiderFlash) or 12 months with an ILR (Medtronic LINQ with CareLink). Unlike recently completed cardiac monitoring trials we expect the majority of patients included will have at least one determined TIA/stroke etiology. The primary endpoint is clinically actionable AF (> 24 hours).

ACHIEVE (AmbulanCe Housed Ischemic Stroke TrEatment with intraVEnous Thrombolysis)

ACHIEVE is a pilot study of 50 patients and will be Edmonton-based. A CT ambulance with a stroke fellow and a radiology technician will be dispatched to meet an 'in-bound' ambulance from rural centres. The "Rapid North" emergency service will identify patients. Consent and preliminary blood work will be obtained at the rural hospital. The CT-ambulance will rendezvous with the in-bound ambulance, patient imaged and evaluated via tele-medicine with a stroke expert in Edmonton. Patients will have tPA treatment started in the field. The outcomes will be patient safety, primary diagnosis and stroke-onset-to-treatment time. Baseline, treatment and outcome data will be collected in clinical routine in the registry. 

View the ACHIEVE Presentation (Shy Amlani)

ESCAPE(Endovascular Treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis o n minimizing CT to recanalization times) 

The primary objective of ESCAPE is to show that rapid endovascular revascularization amongst radiologically selected (small core/proximal occlusion) patients with ischemic stroke results in improved outcome compared to patients treated in clinical routine. This is a phase 3, prospective, randomized open-label with blinded outcomes evaluation (PROBE), controlled, parallel group design trial. It will enrol 400 patients, randomized 1:1 and involve 20-25 centres in Canada, and elsewhere. Patients will have a disabling stroke, have a proximal anterior circulation occlusion (ICA or MCA), have good collateral circulation evident on CTA. In the endovascular arm, they must be treated with CT-to-recanalization time < 90 minutes. The primary outcome will be assessed on the modified Rankin Scale at 90 days. The trial has begun in the vanguard phase with 55 patients enrolled at 10 sites. The two Alberta sites (Edmonton and Calgary) will enrol half of all the patients. The registry infrastructure and door-to-needle time initiative will be critical to patient enrolment. 

[visit escapetrial.org]

View the ESCAPE presentation (Dr. MD Hill)

View the ESCAPE video: The need for speed (University of Calgary - Department of Clinical Neurosciences)

ASPECTS-P (Alberta Stroke Evaluation with CTP) - Improving Treatment Selection Algorithms

ASPECTS-P is a prospective observational study. All patients presenting with major acute ischemic stroke within 12 hours of onset will be included. Acute imaging will be done with non-constrast CT and CT angiography as per clinical routine. CTP will immediately follow. Follow-up brain imaging at 24-48 hours is part of routine clinical care and will be utilized to determine final infarct volume. The diagnostic yield and prognostic value of CTP maps will be measured in real time by the treating clinical team, and by blinded raters in the two stroke imaging core labs. Baseline, treatment and outcome data will be collected in clinical routine in the registry.

ICH ADAPT-2 (Intracerebral Hemorrhage Acute Decreasing Arterial Pressure Trial)

ICH ADAPT-2 is a randomized study of aggressively (target systolic PB <140 mmHg, n=135) versus conservative (<180 mmHg, n=135) BP management in acute ICH. Patients will be randomized to one of these BP targets within 4.5 hours of onset. BP reduction to these targets will be maintained for 24 hours after randomization. All patients will undergo MRI, including diffusion-weighted imaging (DWI) sequences for assessment of ischemic injury at 7 days. The primary endpoint is the ischemic lesion rate at 7 days. Our hypothesis is that the number of DWI lesions in the <140 mmHg target group will not be greater than that in the <180 mmHg group. Baseline, treatment and clinical outcome data will be collected in clinical routine in the registry.