Monitoring Radiation Induced Cardiac Damage by Blood Markers

Radiation Induced Cardiac Damage Clinical Trial

— CARD  

Official title:

Monitoring Radiation Induced Cardiac Damage by Blood Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481778
• Other study ID #: RT2014-01
• Status: Completed
• Start date: September 8, 2015
• Est. completion date: August 2020

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale:

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.

Objective:

The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)

• Older than 18 years

• Written informed consent

Exclusion Criteria:

• Prior radiotherapy to the chest including radiotherapy for breast cancer

• Patients treated with palliative intent

Related Conditions & MeSH terms

• Radiation Induced Cardiac Damage

Intervention

Other:
• Blood sampling

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percentage of rise of the level of NT pro BNP after radiotherapy		At 1 year after end of radiation therapy
Secondary	Cardiac events	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.	After start treatment up to 2 years after end of radiation therapy.
Secondary	Change in percentage of rise of hs-TNT during or after treatment		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.