4.1 The main questionWhat is the effect of temporarily stopping PPI use on the stomach wall uptake of Tc99m Sestamibi with a myocardial perfusion?4.2 Sub-questions:- What is the relative maagwanduptake a myocardial perfusion Tc99m Sestamibi with…
ID
Source
Brief title
Condition
- Myocardial disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
9.1 Quantitative data collection
Of each participant, the sex, age, height, weight, BMI and noted the breast
size. The breast size is measured prior to the first study. Measured
horizontally over the body over the largest parts of the breast in centimeters
(cm). The breast size may have an influence on the detector - organ distance.
Deviations in the quality and measurements can be thus explained. The
quantitative data collection is carried out by means of placing ROIs. ROI's are
placed by the operator on project planar images of the heart and stomach wall
ROIs are with a size of 6 pixels placed, by means of the reconstruction
computer, on the images from the raw data. To answer the main question of the
relationship between maagwanduptake and myocarduptake to be determined. To the
stomach wall, and the entire myocardium inferiorwand be able to assess best be
used in the non-attenuation-corrected images, ROIs drawn. Specifically, on the
left anterior oblique (LAO), slice 17, and the anterior recording, slice 33.
Slice 17 and slice 33 are images to which the stomach wall to quantify is the
best (21). Slice on 17 and 33 is for the entire heart also signed an ROI. If
the stomach wall exhibits a higher uptake than the inferiorwand, the counts per
pixel in the inferiorwand are averaged, whereby the uptake of the actual
inferiorwand may vary with the reality. By drawing an ROI in inferiorwand can
be accurately determined whether stopping PPIs, affecting the uptake of
inferiorwand. There calculate two ratios:
- Entire myocardium - stomach ratio
- Inferior wall of the myocardium - stomach wall ratio
From the slice 17 and 33 are calculated throughout the heart rate and stomach
inferiorwand-stomach ratio. Of these two directions is calculated an average
value of each ROI (21). The result is set forth in counts per pixel. To convert
the result in counts per pixel calculation must be performed in relative
activity. First, the actual administered activity of the radiopharmaceutical is
determined. The administered activity is displayed in the application of
research. If the investigation should not be carried out at the appointed time
be performed Activity calculation for the decay in time.
The decay formula, the current dose is calculated: At = A0 x 0.5 ^ (t / HVT)
At = activity in MBq at start acquisition
A0 = activity in MBq at calibration time (indicated on sticker application form)
t = time difference in hours between the calibration time and start acquisition
HVT = the half-life of 99m technetium (6.0 hours) (43).
By dividing the result of the dose calculated by the body weight of the
participant and counts per pixel is determined, the relative uptake in MBq / kg
per counts / pixel. The relative uptake shows the measured relative uptake in
the stomach wall, or the entire myocardium to inferiorwand.
The collected data is processed by the project executor in the validated data
management research manager system (DMRM) V 5.12.1.0. the Rijnstate hospital.
For any publication data processing required in a validated database. Then the
data from DMRM is exported and imported into IBM statistical Package for the
Social Sciences (SPSS) version 23.0. SPSS is tested with the DMRM may not.
9.2 Visual data collection
The myocardial images are assessed by two nuclear medicine on the basis of a
brief questionnaire. Using the questionnaire, the visual assessment of the
level. After post-processing, patients in the PACS system in a separate folder
automatically anonymous computer. On this anonymous data to find the visual
assessment instead. The project supervisor fills the assigned anonymous names
filled in the questionnaire. Because the evaluating nuclear medicine physicians
do not know which participants PPIs have they may be regarded as blind
continued or phased external readers. The questionnaire in Annex 5 aims to
determine the ability to assess the inferiorwand of the myocardium. Another
object of the questionnaire is to examine whether re-acquisition is necessary.
The answers to the questionnaires are processed by the project executor in DMRM
and SPSS.
9.4 Randomization and blinding
Blinding of participants for the nuclear medicine has the advantage of
assessing the nuclear medicine as external blind readers. This increases the
reliability of the examination. Patients are randomly by the investigator to
the nuclear medicine submitted for review.
During this study is de-blinding will take place only in emergencies. A
de-blinding can be done by the principal investigator, just in case: medical or
safety reasons.
9.5 Research pause or stop
Patients can take at any time waive the study without consequences or
statements. The principal investigator is still often exclude patients after
inclusion for a medical emergency.
Secondary outcome
The results of the qualitative measurements and the visual feedback of the
participants in I.G. 1,compared with the results of the qualitative
measurements and the visual feedback of the participants in I.G. 2. A similar
comparison is applied at I.G. 1 in respect to C. G. 3. The outcome is to
demonstrate or difference is present in maagwanduptake when PPI use is
discontinued or continued. The outcome is unity expressed relative uptake in
MBq / kg counts per pixel for the qualitative measurement. The outcome measure
for the visual evaluation or re-acquisition is necessary.
The normal distribution is assessed by means of histograms. In a normal
distribution of the quantitative results of the intervention groups are yellow
with each other and tested with the unpaired t test. When the distribution is
not normal, the Mann-Whitney U test offers an alternative. In all statistical
analyzes a P *0.05 is considered to be statistically significant. With a
p-value can be shown, or a difference in discontinuation or continuation of
PPIs and the results are not coincidental if p is *0.05.
When the visual data is evaluated using histograms on a normal data
distribution. To demonstrate consistency or independence of the subjective
image quality is tested using the chi-square test. The responses of the nuclear
medicine are tested to demonstrate a statistically significant difference. The
outcome of the Chi-square (X2)) is an absolute number. With the Chi-square test
you can prove or selected values are based on chance or that a difference
actually exists. The intraclass correlation coefficient (ICC) test, is tested
to what extent the nuclear medicine match rate. The ICC values between 0 and 1,
where 1 represents maximum agreement. An ICC value of 0.7 or higher is
considered satisfactory agreement.
Background summary
In 2014, 5308 patients died in the Netherlands from a myocardial infarction
(1). The mortality ratio is 55% male and 45% female (1). Atherosclerosis in the
coronary arteries reduce blood flow to the heart (2). A total closure of the
coronary artery can lead to a stroke (3-8). A result of a perfusion disorder is
ischemia; oxygen deficiency of the underlying myocardial cells (8). The sooner
diagnosed, the lower the mortality rate, and the higher is the life expectancy
(9). In nuclear medicine, is diagnosed with the help of a myocardial perfusion
scintigraphy (MPS), perfusion disorders.
The MPS visuals the myocardium, through the myocardial SPECT technique (3 to
8.10). The purpose of SPECT is the creation of cross-sections and 3-D images of
the distribution of the administered radiopharmaceutical taken on a series of
static images around the patient (11,12). During the investigation, multiple
images from multiple directions with the gamma camera that rotates around the
patient. (11). In addition to the images that have come into position by means
of the myocardial SPECT technique can be carried out with the aid of an
additional study a CT attenuation correction (attenuation correction) for the
myocardial SPECT technique (13). The purpose of the attenuation correction is
to correct for distance between the organs and the detector so as to give a
real uptake of radioactive agent again. This reduces the sensitivity and
specificity higher and perfusion disorders can be better visualized (13.14)
.The myocardperfusieonderzoek has diagnostic value, with a sensitivity between
77% and 95%, and specificity between 78% and 83% is achievable (6 , 7,10,15-17).
The MPS consists of a research in stress and rest. To diagnose a stroke or
ischemia, the images from the stress and rest were compared (11). An infarction
is characterized if the deviation is visible in the research effort and peace
research (11). An ischemia is characterized if the deviation by stress testing
is visible but not (11) at rest. For MPS is a radionuclide Technetium
99metastabiel (99mTc) Sestamibi tracer coupled specific to an organ. A
radionuclide that is linked is referred to a radiopharmaceutical tracer (11).
For stress effort is maximum effort necessary for maximum uptake of the
radiopharmaceutical. At maximum effort, deviations mapped optimally. With the
aid of a cycling test or drug administration with the agents adenosine or
regadenoson, the maximum effort of the myocardium is obtained. There is no
difference detected in diagnostic value, if adenosine or regadenoson is used.
(18-20). Approximately 1.2-1.5% of the administered dose of 99mTc-Sestamibi is
taken up by the myocardium (11).
Not all of the radiopharmaceutical 99m Tc Sestamibi is incorporated into the
myocardium, in addition, is also recording (uptake) of radiopharmaceutical in
other parts of the body present. This is called external cardiac uptake and is
often visible in organs below the diaphragm and liver, duodenum, gall bladder,
intestines and stomach (21-27).
Extracardiac uptake may cause scattered radiation (scatter) and overlap, and
change the uptake in the myocardium. (21,24,25,27-32). Extracardiac uptake can
contribute to a bias in the distribution of the radiopharmaceutical, mainly in
the inferiorwand myocardial (22,23,26,27,33,34). As a result, it becomes more
difficult to assess the inferiorwand. It may seem that the inferiorwand shows
perfusion disturbances, while the actual situation otherwise occur (33,34). A
too high extra cardiac uptake can lead to a poor rating of the inferior wall,
so that re-acquisition is required (21 to 23.34).
When a reduction of the additional cardiac uptake, the inferiorwand can be
better assessed from milk and drinking water have an impact in order to reduce
the interfering additional cardiac uptake (16-18,20-22,24,26-29). Milk
stimulates peristalsis of the intestines and stimulates the liver for excretion
of radiopharmaceuticals. Water reduces activity in the stomach because the
stomach acid is diluted (21,23,25,26,31). The reduction of additional cardiac
uptake by milk and water, is insufficient to be able to assess the myocardium
well. It is clear from previous studies that the taking of stomach protective
drugs also called proton pump inhibitors mentioned (PPIs), leads to an
increased uptake of the radiopharmaceutical in the stomach wall (22,25,29,31).
Patients who suffer from include heartburn, stomach problems encounter,
dyspepsia have, or will use pain relief funds eligible to use proton pump
inhibitors. PPI use reduced stomach acid (36.37) .Patiënten use PPIs chronic (>
90 days) or preventive (<90 days) (38).
The chronic use of pain control agents, the so-called non-steroidal
anti-inflammatory drug (NSAID), the chronic use of PPIs often has the effect of
(36-38). Chronic PPI users are excluded because risk of reflux symptoms,
inflammation, heartburn and side effects are greater if this group of patients
stopped using PPIs (37.38). Patients taking PPIs preventive use less risk of
complications, because the PPI prevention is used. (37,38). When PPI users stop
immediately, often occur reflux disease, inflammation and heartburn at (36,38).
This would limit participation in the study. When PPIs are stopped with a
reduction schedules, enter reflux and heartburn symptoms less rapidly (36). Or
the temporary stop of PPIs also leads to a better assessment MPS, is at this
time still unknown.
Previous research has shown that the use of PPIs affects the stomach wall
uptake (29,31) Both studies show if patients use PPI, this leads to an
increased maagwanduptake. Rijnstate hospital in Arnhem would like to
investigate the effect on stomach wall activity at MPS, as PPI use is
discontinued in patients taking preventive PPIs. A valid assessment leads to
less re-acquisitions and probably improve patient care. In this study answers
the question: What is the effect of temporarily stopping PPI use on the stomach
wall uptake of 99m Tc-Sestamibi in a myocardial perfusion imaging?
Study objective
4.1 The main question
What is the effect of temporarily stopping PPI use on the stomach wall uptake
of Tc99m Sestamibi with a myocardial perfusion?
4.2 Sub-questions:
- What is the relative maagwanduptake a myocardial perfusion Tc99m Sestamibi
with exertion Be it peace studies, in patients who have stopped taking PPIs,
compared with patients who continue with PPIs?
- How stopping PPIs may affect the image quality and the ability to assess a
myocardial perfusion
4.3 Hypothesis
It is expected that the temporary cessation of PPIs for myocardial perfusion
imaging shows an equivalent image in patients not taking PPIs.
Study design
The study is a prospective quantitative research. Participants must give
permission by signing an informed consent, can be found in Annex 4 to take part
in the study. Participants will temporarily stop the use of PPI through the
reduction schedule of the pharmacy. Examples of common PPIs are: Omeprazole,
Esomeprazole and Pantoprazole. Annex One is a detailed overview of different
properties and forms of administration by PPI. Reducing the PPIs take about two
to three days (39). The cardiologist select patients taking PPIs and get a MPS.
In nuclear medicine is being investigated by the project promoter, or patients
using chronic or preventive PPIs. With the aid of the following in and
exclusion criteria, patients are screened and selected. Selected patients will
be contacted by telephone. To maintain overview to potential participants, just
by lead investigator Dr. Schelfhout, a colleague or project executor contacted.
In case participation is additional information, the reduction schedule, and
the informed enclosed with the appointment confirmation. The secretariat will
send two to three weeks prior to the survey by mail appointment confirmations.
One week prior to the study, a second telephone consultation location. This
consultation will be clarified ambiguities. A cooling-off period of at least
one week is guaranteed in this way.
Because a MPS consists of a research effort and rest, participants will be
placed in the intervention groups, schematic representation in Figure 1. In
total, gives rise to three intervention groups:
I. G. 1: strike stress Research - continue rest Research
I. G. 2: continue stress Research - rest Research strike
I. G. 3: continue stress Research - continue rest Research
Intervention Group 3 continues with PPI use in both studies and forms the
control group. Intervention group 3 from now control called abbreviated C. G.
By comparing two efforts or peace studies together, it can be shown, or a
difference in gastric wall uptake exists when PPIs are discontinued or
continued. Also, different data can be easily traced and corrected. The
following groups are for both stress and rest were compared:
I. G. 1 - I.G. 2
I. G. 1 - C.G. 3
I. G. 2 - C.G. 3
With the aid of the control group it can be shown that the results are not due
to chance. By comparing each intervention group with the control group taking
PPI use is unchanged, it is shown that the effect occurred not due to chance.
In Rijnstate hospital in Arnhem, the stress test will be examined first and one
to four days later the rest research (11). This study will I.G. 1 as the rest
research be carried out first, and from one to four days later, the stress
test. In this way, the informed consent can be delivered / signed at the first
examination. At that time, no reduction of PPIs yet occurred.
Intervention
-
Study burden and risks
-
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
- Patients with a cardiology reference indication for myocardial perfusion imaging.
- Patients older than 18 years.
- Patients wherein for the myocardial perfusion preformed with etheir adenosine or regadenoson
- Patients taking preventive less than 90 days using PPIs
- Patients who have signed an informed consent.
- Patients in which the scan was performed on the scanner BrightView 1 in Nucleare department Rijnstate Arnhem.
- Patients who have no defects at the myocardal inferiorwall.
Exclusion criteria
- Patients with dyspepsia
- Patients with only uptake in the stomach cavity, thus no reliable measurement can be done and no visually assesment can be reliable preformed.
- Patients who are not prepared and tested according to the protocols
- Patients with the following well-known diseases, Zollinger Ellison Syndrome, a barrettoesofagus or a esophagitis with endoscopic grade C or D
- Patients partially been injectjet or underskin injection, no maximum uptake of radiopharmaceutical is can be reached.
- Patients that use medications that interact with PPIs.
- Patients with gastric resection or surgically treated for stomach problems.
- Patients with gastric ulcer prophylaxis.
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 |
|---|---|
| EudraCT | EUCTR2016-001383-10-NL |
| CCMO | NL57340.091.16 |