The purpose of this study is to investigate whether H/M ratios from late scans, performed earlier than 4 hours post-injection of MIBG, are comparable with those determined at 4 hours
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the calculated H/M ratio at 1, 2 ,3 hour p.i.
of MIBG compared to the H/M ratio at 4 hours.
Secondary outcome
Secondary study parameter will be the time savings which can be achieved if the
H/M ratio is not significant different between these different scan times.
Background summary
Patients with severe chronic heart failure have worse prognosis. Up regulation
of the sympathetic innervation of the heart is an important compensation
mechanism. Meta- iodobenzylguanidine (MIBG), an analogue of norepinephrine,
linked to Iodine-123 can be used to assess non-invasively the norepinephrine
uptake of presynaptic cardiac sympathetic nerves of the heart. The amount of
retention of MIBG over several hours after administration reflects neuronal
integrity. Reduced myocardial MIBG uptake has been demonstrated to have strong
prognostic value. The most commonly used quantitative measurement of myocardial
MIBG uptake is the calculated heart-to-mediastinum (H/M) ratio and washout
ratio determined from the planar MIBG images. A low H/M ratio is shown to be an
independent predictor of ventricular tachyarrhythmia*s, appropriate ICD-therapy
and sudden cardiac death in HF patients.
To determine H/M ratio and washout rate of MIBG at planar images, patients are
standardized scanned 15 minutes (early) and 4 hours (late) after administration
of MIBG. However, there is a wide variety in reported acquisition times for the
late images (range from 2 to 5 hours after administration of MIBG). This raises
the question if strict adherence to the time schedule is necessary to determine
the H/M ratio and washout rate.
Study objective
The purpose of this study is to investigate whether H/M ratios from late scans,
performed earlier than 4 hours post-injection of MIBG, are comparable with
those determined at 4 hours
Study design
Consecutive patients with heart failure, referred for MIBG myocardial
scintigraphy for prognostic purposes, will be scanned 15 minutes and 4 hours
post-injection of MIBG as usual. Extra scans will be performed 1, 2, 3, hours
after the early (15 minutes) scan.
With inclusion of 2-3 patients a week in 2 centers, it is expected that after 1
year the inclusion of 87 patients is completed.
Study burden and risks
The benefit for this patient group may be a significant time saving if it seems
that H/M ratios at earlier scans are the same as compared to scans performed at
4 hours.
There can be a risk that in this group of patients with heart failure the extra
time of laying flat under the gamma camera will be uncomfortable for the
patients and give them more dyspnea complaints.
Albinusdreef 2
2300 RC Leiden
NL
Albinusdreef 2
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Age 18-75 years old
Symptoms of heart failure
Able to lie flat on a table for 10 minutes
Exclusion criteria
Severe shortness of breath which makes it impossible for the patient to lie flat for several times under a gamma camera.
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 | NL40976.058.12 |