To determine and validate the minimal rest tracer activity for accurate diagnosis in a one-day stress-first MPI SPECT setting.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Minimal rest tracer activity for which no change in the following parameters is
seen in comparison to using the reference scan. 1) Change in tracer perfusion
deficit, a semi-quantitative outcome assessment, 2) change in any of the
17-segments representing the relative perfusion in the myocardium, and 3)
change in defects and type of defects as observed by blinded physicians
Secondary outcome
-
Background summary
Myocardial perfusion imaging (MPI) remains important in the evaluation of
patients with (suspected) coronary artery disease (CAD). Despite decades of
experience and technical improvements, the tracer activity to administer in MPI
using single photon emission computed tomography (SPECT) has remained the same
over the years. SPECT studies consist of two tracer administrations, one during
stress, and during rest. Recently, dose reductions of up to 60% of the stress
injections have become feasible. In a one-day protocol a certain relation
between the two injections is needed, but guidelines propose different ratios
and hard evidence is lacking.
Study objective
To determine and validate the minimal rest tracer activity for accurate
diagnosis in a one-day stress-first MPI SPECT setting.
Study design
Single center, diagnostic accuracy study using intra-individual comparisons of
SPECT scans.
Study burden and risks
The first 32 patients are only requested to lie in de SPECT scanner for 10
minutes instead of waiting in the waiting room.
For the last 32 patients the study will take one hour more than usual.
Moreover, an additional tracer administration - which does not have any side
effects - using the already installed infuse will be administered and these
patients need to lie extra in the SPECT scanner for 5 minutes. By dividing the
rest activity administration over two syringes, patients do not receive any
additional tracer activity. Hence, they receive the same radiation dose as
patients not participating in the study.
Dr. Van Heesweg 2
Zwolle 8025AB
NL
Dr. Van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
Have undergone stress myocard perfusion imaging using SPECT and undergo a clinically indicated rest SPECT
Exclusion criteria
-No informed consent obtained
-Age < 18 years
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 | NL54850.075.15 |