Monitoring Radiation Induced Cardiac Damage by Blood Markers (CARD)
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|ClinicalTrials.gov Identifier: NCT02481778|
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : October 25, 2017
Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.
Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.
The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.
|Condition or disease||Intervention/treatment|
|Radiation Induced Cardiac Damage||Other: Blood sampling|
|Study Type :||Observational|
|Estimated Enrollment :||87 participants|
|Official Title:||Monitoring Radiation Induced Cardiac Damage by Blood Markers|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
- Change in percentage of rise of the level of NT pro BNP after radiotherapy [ Time Frame: At 1 year after end of radiation therapy ]
- Cardiac events [ Time Frame: After start treatment up to 2 years after end of radiation therapy. ]A new diagnosis of: heart failure, myocardial infarction or a newly diagnosed rhythm disorder will be scored as a cardiac event. Myocardial ischaemia requiring intervention and changes in cardiac medication in case of deterioration of known heart failure will be analysed by a cardiologist to decide whether or not to score this as an event. Events will be scored according the CTCAE 4.2 criteria.
- Change in percentage of rise of hs-TNT during or after treatment [ Time Frame: At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481778
|Contact: J.C. Beukema, Dr.||+firstname.lastname@example.org|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9700RB|
|Contact: JC Beukema, Dr. +31503610025 email@example.com|