IMMEDIATE TRIAL INFORMATION
Home
Study Overview
Study/History Timeline
What is IMMEDIATE GIK?
Patient Enrollment
Participating Sites
Research Team
News and Events
Glossary of Terms
Articles and Resources
Biological Mechanism Cohort Information
Only a small subgroup of people will be asked to participate in this part of the IMMEDIATE Trial.

What is the Biological Mechanism Cohort?
This is a small group of people who will be asked to participate in an additional part of the IMMEDIATE Trial to better understand the biological mechanisms that may lead to a benefit from GIK. Specifically, this part of the study will test if GIK decreases the level of a fat in the blood that may cause an irregular heart beat in people who may be having a heart attack. In addition, it will help determine whether the study drug solution decreases the amount of heart muscle damage.

Do I have to participate in this part of the trial?
You may be asked to participate, but you have the right to decline participation. A full written informed consent form will be given to you to read and ask questions prior to making a decision.

What is involved?
You will continue on the study drug solution for 12 hours. As soon as possible, a blood sample (2 tablespoons) will be taken to test for levels of a fat in the blood, an insulin level, and to see how well your body controls its blood sugar (Hemoglobin A1C). Two additional blood samples will be taken (2 tablespoons each) to measure the levels of a fat in the blood, and insulin levels at approximately 6 hours and 12 hours after the start of the study drug solution or when the solution is stopped (if before 12 hours).

How long will I have to participate?
You will be asked to return for an appointment at the hospital in approximately 30 days to have one additional research blood sample taken (1 tablespoon) to measure a protein level and a scan of your heart (a sestamibi scan) will be performed. These tests are done to measure the level of damage to your heart.

Are there any risks to participating?
You may experience discomfort and or, bruising at the site of the blood draws. When possible these will be coordinated with routine blood drawings. There is small risk of bruising at the injection site of the solution used with the heart scan, and a very small amount of radiation exposure from the radioactive solution used with the heart scan (isotope). However, this is a standard test done in nuclear medicine laboratories for patients with suspected heart disease. If you are pregnant at the 30-day follow-up you should not have the heart scan, as there may be risks to your unborn.

  Massachusetts
  Texas
  Wisconsin
  Inclusion/Exclusion Criteria
  Enrollment Process
  Community Consultation & Public Notification  
  What is a Clinical Trial?
  Heart Attack Facts
  Frequently Asked Questions
  Biological Mechanism Cohort
  Genetic Ancillary Study
  Abstract
  Background
  Study Design and Procedures
  ECG Predictive Instruments
  Paramedic Training