Tight Glycemic Control Increases Cardiac Stem Cells During Acute Myocardial Infarction

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

The investigators analysed the effects of tight glycemic control in regenerative potential of the myocardium during acute myocardial infarction (AMI).

The role of tight glycemic control in regenerative potential of the myocardium during acute myocardial ischemia are still largely unknown.

It had three arms (groups): 1 (no intervention), 2 (active comparator) and 3 (experimental).

25 normoglycemic patients as control group.

The registry classes the interventions as drug.

More on the Plan

The study design was structured on the basis of protocol Yale .

Upon emergency wards admission, hyperglycemic patients were randomly assigned to IGC or CGC.

In patients with STEMI the insulin infusion was started after thrombolysis.

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

Who Took Part

Enrollment: 65 actual participants took part.

It was open to people of any sex aged from 40 years up to 70 years.

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

Examples of who could join: First uncomplicated AMI. The need for CABG.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: previous ami; inflammatory disorders; renal diseases infections.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2001-01 with completion listed for 2008-06.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: cardiac stem cells during acute myocardial infarction (time frame: 3 days of treatment).

It also tracked 1 secondary outcome, for example heart remodeling during acute myocardial infarction.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 65 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.