Have You Had a Heart Attack or Bypass Surgery in the Last Six Months?

Study Summary

The University of Chicago and Dr. Burke are conducting a study to determine the safety and effectiveness of a new experimental medical device. More than one million people suffer a heart attack every year. Getting treatment at the earliest onset of symptoms is critical to recovery. This study involves implanting a device that is designed to alert patients when it detects changes in the heart that might indicate the onset of a heart attack.

For the purposes of this study, you will be assigned to one of two groups: Active group and Control group. The Active group will receive the experimental device and the device will monitor your heart condition and you will be alerted to any abnormal heart signals that could be an indicator of a dangerous heart rhythm or heart attack. The control group will also received the experimental device and the device will monitor your heart but will not alert you to any abnormal heart signals. After six months of being enrolled in the study, the subjects in the control group will have the alerts turned "ON" and will receive alerts of abnormal heart signals. Both groups will receive standard of care treatment for your heart condition.

You will be asked to participate in this manner for up to two years. You will have scheduled clinic visits at the University of Chicago at months 1, 3, 6 and every six months after that.

Benefits

There may be no benefit to you for participating in this study. However, the potential benefits from participating in this study are:

1. You will receive an implantable device that will continuously monitor your heart's signal, and automatically collect data that will be reviewed by your doctor. This may help your doctor to manage your heart condition going forward.
2. The device will alert you when it detects a potential condition that could indicate you are having a heart attack. This may enable you to seek medical attention sooner than you would have without the device.

Participation Details

Initial selection criteria include:

• Have experienced a heart attack, unstable angina, or undergone bypass surgery within the past six months
• Have diabetes, poor kidney function, or other risk factors
• Live within 60 minutes of a hospital
• Not need or already have a pacemaker or internal defibrillator
• Have not had a stroke or internal bleeding within the past six moths
• Must meet study medical criteria as evaluated by Dr. Burke

Study Director: Dr. Martin Burke
Department: Cardiology

For more information contact:
Melissa Byrn
(773) 834-7157
byrn@medicine.bsd.uchicago.edu

IRB: #16511A