Radiation Therapy and Cardiac Enzymes
The goal of this clinical research study is to learn if the radiation that you are receiving will result in an increase in certain proteins produced by the heart called cardiac biomarkers.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Radiation Therapy and Cardiac Biomarkers|
- Elevation in cardiac biomarkers by measuring cardiac troponins (troponin T and troponin I), BNP, and CK-MB. [ Time Frame: 4 Time Points: within 1 week prior to radiation therapy (RT), within 1-3 days of RT completion, and at 1 and 3 months after completion of RT. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Cardiac biomarkers are proteins made by the heart. When cardiac biomarkers are above normal levels, there may be damage to the heart. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy. How cardiac biomarkers can play a role in predicting future heart problems during radiation therapy will also be studied.
If you agree to take part in this study, blood (about 1 teaspoon) will be drawn to measure certain cardiac biomarkers up to 2 days before radiation therapy, following the first treatment of radiation, within 2 days of finishing radiation therapy, and about 1 to 2 months after completion of radiation therapy. Once the blood testing is completed, any leftover blood samples will be destroyed.
You will also have electrocardiograms (ECGs -- tests that measure the electrical activity of the heart) at the same time points as the blood draws.
Length of Study:
You will be off study after the last blood draw and ECG.
This is an investigational study. Up to 30 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777751
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David Grosshans, MD||UT MD Anderson Cancer Center|