Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165425
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2005-09-09
Brief Title:
Cardiac Screening in Survivors of Hodgkins Disease Treated With Mediastinal Irradiation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Cardiac Screening in Survivors of Hodgkins Disease Treated With Mediastinal Irradiation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkins disease In this study we would also like to screen for cardiac risk factors that can be modified either through life-style changes or medications to uncover significant abnormal heart findings in which treatments may be needed and to see if there is a link between cardiac health and quality of life
Detailed Description:
On the day of the patients scheduled follow-up visit with their oncologist additional blood work will be obtained and the patient will fill out questionnaires concerning their general health and assessing quality of life
A separate cardiology visit with a preventative cardiologist will be performed At this visit the patient will undergo a Stress Echocardiogram
A Stress Echocardiogram is made up of three parts Resting echo study stress test and repeat echo while the heart is still beating fast
A resting echo provides the baseline examination and demonstrates the size and function of various chambers of the heart
The stress test involves exercise using a treadmill or a stationary bike In patients who are unable to complete a high level of exercise due to physical limitations stress to the heart is provided by a pharmaceutical or chemical stimulation to the heart Exercise is started at a slower warm-up speed and then increased every 3 minutes Exercise is abruptly stopped once the patient exceeds 85 of the target rate EKG recordings are made every minute of exercise and then again after exercise is stopped Blood pressure is recorded at three minute intervals during exercise and then again at rest
Immediately after exercise is stopped the patient will undergo a repeat echocardiogram
If no cardiac abnormalities are detected the screening tests will be repeated every 3 years if the patient is less than 10 years out from their initial treatment If the patient is more than 10 years from initial treatment then the tests will be repeated at approximately 18 months from the initial screening and once more at the end of the third year
A separate cardiology visit with a preventative cardiologist will be performed At this visit the patient will undergo a Stress Echocardiogram
A Stress Echocardiogram is made up of three parts Resting echo study stress test and repeat echo while the heart is still beating fast
A resting echo provides the baseline examination and demonstrates the size and function of various chambers of the heart
The stress test involves exercise using a treadmill or a stationary bike In patients who are unable to complete a high level of exercise due to physical limitations stress to the heart is provided by a pharmaceutical or chemical stimulation to the heart Exercise is started at a slower warm-up speed and then increased every 3 minutes Exercise is abruptly stopped once the patient exceeds 85 of the target rate EKG recordings are made every minute of exercise and then again after exercise is stopped Blood pressure is recorded at three minute intervals during exercise and then again at rest
Immediately after exercise is stopped the patient will undergo a repeat echocardiogram
If no cardiac abnormalities are detected the screening tests will be repeated every 3 years if the patient is less than 10 years out from their initial treatment If the patient is more than 10 years from initial treatment then the tests will be repeated at approximately 18 months from the initial screening and once more at the end of the third year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None