Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

It had three arms (groups): control (no intervention), Insulin 1 (active comparator) and Insulin (experimental).

No hyperglycemia patient group.

Conventional insulin treatment.

Intensive insulin treatment.

The registry classes the interventions as drug.

More on the Plan

The study design will be structured on the basis of protocol Yale.

Upon emergency wards admission, all patients will be assigned to undergo prompt coronary revascularization.

After PCI procedures, hyperglycemic patients will be randomly assigned to intensive glucose control (IGC group) and those treated with conventional glucose control (CGC group).

After the start of insulin infusion protocol a glycemic control will be provided every hour in order to obtain three consecutive values that were within the goal range.

Who Took Part

200 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Chest discomfort lasting at least 15 min within the last 24 h,. New \>l mm ST-wave or dynamic T-wave changes in at least two contiguous ECG leads,. Troponin I levels above the 99th percentile 6-12 h after the onset of chest pain. Patients referred to the cardiac catheterization laboratory within 24 h of symptoms.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: hemorrhagic diatheses,; contraindications or allergy to aspirin, thienopyridines, and history of anaphylaxis in response to iodinated contrast medium,; leukocyte count of less than 3500/mm3, platelet count of less than 100,000/mm3.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2009-12 with completion listed for 2010-06.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Coronary angiograms (time frame: at baseline, immediately after PCI, and at 6 months).

It also tracked 1 secondary outcome, for example IVUS Imaging.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 200 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.