SELESTIAL: Trial of Insulin to Control Blood Sugar After Acute Stroke Using Magnetic Resonance Imaging (MRI) End-Points

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

Treatment with insulin infusions is proposed as a neuroprotective strategy, and a clinical trial is ongoing to test this hypothesis.

The registry classes the interventions as drug.

More on the Plan

Hyperglycaemia remains a powerful independent predictor of outcome even in the face of thrombolytic drug therapy.

In addition to brain structure, MRI can define tissue viability (cytotoxic oedema seen on diffusion-weighted imaging, DWI), brain perfusion (bolus-tracking perfusion imaging, PI), vascular integrity (MR angiography, MRA) and tissue metabolism (1H MR spectroscopy, MRS).

In acute middle cerebral artery (MCA) occlusion, evolution of cerebral damage has been defined with these techniques.

The volume of hypoperfused tissue on PI initially exceeds the DWI lesion, and, over time, the DWI lesion expands to finally incorporate the majority of the PI lesion.

Who Took Part

Enrollment: 45 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Lesion on acute diffusion weighted MRI. \>18 years age.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: major concomitant illness limiting survival.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

It started in 2004-05.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Lesion volume expansion at 1 week.

It also tracked 5 secondary outcomes, for example Brain lactate concentration change baseline-day 3, 30 day modified Rankin Scale score, 30 day NIHSS and 30 day Barthel Index.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 45 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.