Methodology of the Interventional Management of Stroke III Trial

Abstract

The primary outcome measure is a favorable clinical outcome, defined as a modified Rankin Scale Score of 0-2 at 3 months. The primary safety measure is mortality at 3 months and symptomatic ICH within the 24 h of randomization.

Safety of High Doses of Urokinase and Reteplase for Acute Ischemic Stroke

“…19 UK is no longer available for use in the United States, and current ongoing clinical trials are using rtPA. The ongoing Interventional Management of Stroke (IMS) III trial limits the IA dose of rtPA to 22 mg. 20 Furthermore, patients randomized to receive ET in the IMS III trial receive two-thirds the standard FDA-approved dose of IVT. The Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy trial also limits the IA dose of rtPA to a maximum of 14 mg regardless of prior full-dose IVT.…”

Inter- and Intraobserver Agreement in Scoring Angiographic Results of Intra-Arterial Stroke Therapy

“…One observer answered the questionnaire twice 3 months apart. Observers were given the task of grading each pair of images according to the 4-value AOL scale 8 and the 5-value TICI scale. 7 The explicit definitions of the 2 scales appeared in explanatory boxes beside the answering boxes for each case.…”

“…6 Thus angiographic scoring systems and a new vocabulary (such as Thrombolysis in Myocardial Infarction [TIMI], TICI, arterial occlusive lesion [AOL], described below) are now used to adjudicate and compare angiographic results of acute stroke therapies. [7][8][9][10][11][12] The precision of outcome scales must be assessed before their widespread use. Testing can be accomplished by asking various individuals to repeatedly but independently categorize the angiographic results of the same patients and by studying intra-and interobserver agreement of the resulting verdicts.…”

Poor clinical outcome despite successful arterial recanalization. What went wrong? How can we do better?

“…The trial design is centered on starting the IV drug and then taking the patient to the angiography suite to recanalize the vessel using chemical or mechanical means when necessary. In IMS-III [9], there is randomization of IV therapy only against IV and IA approach. This trial is currently enrolling, and results are likely at least a few years away.…”