E.D.I.C.T.-Early Detection of Iron Cardiomyopathy In Thalassemia
Thank you for your interest in participating in the EDICT study at Childrens Hospital Los
Angeles (CHLA). Included is an overview of the study. Please read over the information and feel
free to contact Janelle Miller with any questions.
Iron overload of the heart remains a leading threat for thalassemia patients. EDICT is a research
study to explore ways to detect iron overload in the heart caused by chronic transfusions. EDICT
will study the ability of a cardiac MRI and other cardiology tests to predict which patients are at
risk for heart problems over time and try to predict who will develop heart problems in the future.
Help us learn more about the heart in thalassemia. Heart disease is treatable if recognized before
symptoms occur.
This study is being conducted by Dr. John Wood, MD, PhD of Cardiology at CHLA. The coinvestigator is Dr. Thomas Coates, MD of Hematology at CHLA.
Location:
Childrens Hospital Los Angeles
4650 Sunset Boulevard
Los Angeles, CA 90027
http://chla.usc.edu
Contact Person:
Janelle Miller
Office: 323-671-6020 ext 6020
Email: jmiller@chla.usc.edu
Eligibility Criteria for EDICT Study:
1. Must have thalassemia and on chronic transfusions at a minimum of 8 transfusions per
year for a minimum of 7 years (minimum age is 7 years old).
2. Must clear MRI screening criteria (NO pacemakers, implanted electronic device, noncompatible metal implants, claustrophobia (fear of enclosed spaces).
3. Must be able to complete a 1-hour MRI without sedation.
4. Must NOT be pregnant.
5. NO history of bone marrow transplantation.
6. Must have primary thalassemia physician approval.
7. Must be willing to return to CHLA once every year or every other year for the next four
years for “follow-up” (repeat of the initial visit).
8. Must schedule EDICT study date within 7-10 days of receiving transfusion.
Compensation:
Study completion: Subjects will receive $100 for completion of the 2-day study.
Travel: A maximum of $300 will be reimbursed for flight and taxi expenses only after valid
receipts are submitted. Burbank airport is the most convenient and closest airport to CHLA. All
compensation will be processed and mailed to subjects after their completed visit.
EDICT Study Summary
All study tests are performed at no charge to the patient and results will be sent to the patient and
their physician.
Based on test results, subjects will be asked to return for follow-up visits once every year or once
every 2 years. At their request, subjects and their physicians will be provided with copies of test
results to aid in their medical treatment and well-being.
Explanation of tests*(in alphabetical order)
Blood test
A small sample of blood will be collected to undergo various tests.
Electrocardiogram
An EKG is a noninvasive test that records the electrical activity of the heart. Electrodes will be
placed on your body to measure the heart’s rate and rhythm
Echocardiogram
An Echo is a noninvasive test to evaluate how well the heart is working. Gel is applied to the
chest and a transducer (wand-like apparatus) is moved over the chest to produce images of the
heart.
Holter Monitoring
This is a continuous EKG recording of the heart’s rhythm. Electrodes are placed on the chest
with wires and attached to a small recorder. This will be worn overnight.
Magnetic Resonance Imaging (MRI)
MRI is noninvasive and is used to takes images of the heart’s function, heart iron, and liver iron.
Electrodes will be placed on the body and you will lie still in a tunnel-shape machine for one
hour.
Treadmill exercise and pulmonary function tests
For the treadmill test, electrodes will be placed on the chest to measure the heart’s electrical
activity while the subject walks at increasing inclines on a treadmill.
For the pulmonary tests, subjects breathe in and out of a machine to measure oxygen use.
Urine Collection
You will be given directions on how to collect a urine sample overnight.