Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI

What Was Tested

The trial (not phased) is built around Insulin (regular human).

Coronary artery disease is a process that results in "hardening of the arteries".

One approach to treating this condition is a balloon procedure known as coronary angioplasty.

The registry classes the interventions as drug.

More on the Plan

Studies consistently show that diabetes (DM) is an independent predictor of angiographic restenosis as well as clinical outcomes after PCI.

A common criticism of the early PCI trials is that stents were not routinely used.

The pathophysiology of restenosis is viewed as a complex temporal sequence of interactions involving several cellular and mechanical factors including elastic recoil, thrombosis, intimal hyperplasia, extra cellular matrix elaboration, apoptosis, oxidative stress and unfavorable arterial remodeling ("arterial shrinkage").

The exposure of subendothelial elements initiates platelet adhesion and activation.

Who Took Part

The registry lists 240 planned participants were the target.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Patients booked for catheter-based revascularization with balloon angioplasty and coronary stent placement. Type II diabetes mellitus.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: planned staged procedure for multivessel pci taking place over \> 30 days; NYHA class 3 or 4 symptoms of CHF; hba1c \< 0.061 or \> 0..104.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2002-07 with completion listed for 2005-09.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Volume of intimal hyperplasia in the stented segment by IVUS at 6 months following PCI.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 240 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.