To assess whether a decrease in heart volume is accompanied by changes in myocardial strain, strain rate, inferior vena cava diameter and blood levels of NT-proBNP and troponins.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in cardiac volume at baseline compared to weekly measurement during
chemoradiation
Secondary outcome
- Change in inferior vena cava diameter at the end of chemoradiation compared
to baseline
- Changes in myocardial strain and strain rate at the end of chemoradiation
compared to baseline
- Weekly changes in concentration of Creatine Kinase (CK), Creatine Kinase
Muscle type and Brain type (CK-MB), troponin, N-terminal-pro-natriuretic
peptide (NT-pro-BNP)
- Change in LVEF at the end of chemoradiation compared to baseline
- Change in New York Heart Association (NYHA) score at baseline compared to
weekly measurements during treatment.
*
Background summary
The treatment of choice of local resectable esophagus carcinoma is
multimodality treatment with chemotherapy, radiotherapy and surgery. In a
recently published article from Hagen no postoperative cardiac complications
were mentioned, although the heart was partly in the radiation field for the
majority off patients. However, long term cardiac outcome of this regimen is
unknown as median follow-up of the study was 45.5 months, Moreover, cardiac
outcome has not been a specific focus of interest of this study and was not
analysed during chemoradiation. Therefore, subtle signs of emerging cardiac
failure may have been missed.
We have recently observed that during 4,5 weeks of pre-operative chemoradiation
for esophagus carcinoma the cardiac volume on Computed Tomography (CT)
decreased.
Study objective
To assess whether a decrease in heart volume is accompanied by changes in
myocardial strain, strain rate, inferior vena cava diameter and blood levels of
NT-proBNP and troponins.
Study design
Prospective, single center study
Study burden and risks
Extra time
time for completing questionnaire at baseline and at the end of
chemoradiation(total 20 minutes)
time for performing ultrasound of the heart at baseline and at the end of
chemoradiation (total 40 minutes)
time for performing electrocardiogram at baseline and at the end of
chemoradiation( total 10 minutes)
weekly 1 buis extra bloodcollection (total 22.5 ml)
one extra CT scan at the end of chemoradiation (total 10 minutes)
Extra radiation
extra CT scan (extra radiation 30 mSv)
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
patients with esophageal cancer who are planned to be treated with preoperative chemoradiation
Exclusion criteria
cardiac failure NYHA class 3 and 4
previous radiotherapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42999.018.12 |