Skip to content

The effect of withdrawal of PPI use for myocardial perfusion imaging.

Evaluating the effect of short term withdrawal of PPI's in patients for reducing stomach wall uptake with 99mTc Sestamibi for myocardial perfusion imaging

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-001383-10-NL
Enrollment
Unknown
Registered
2016-06-27
Start date
2016-07-04
Completion date
Unknown
Last updated
2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The goal is to acquire knowledge about the impact of the withdrawal of PPI’s, so as to minimize disturbance of the stomach wall in myocardial perfusion imaging. The associated main question is therefore: What is the impact of the withdrawal of PPI use in the stomach wall uptake of 99m Tc-Sestamibi in myocardial perfusion imaging? Myocardial perfusion imaging consists of stress and rest study.

Interventions

Trade Name: Omeprazole ATC code: A02BC01 Pantoprazole ATC code: A02BD04 Esomeprazole ATC code: A02BC05 Product Name: Proton Pump Inhibitors Pharmaceutical Form: Tablet

Sponsors

Rijnstate ziekenhuis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients who have a referral from a cardiologist to a myocardial perfusion imaging. - Patients older than 18 years. - Patients wherein for the myocardial perfusion during exercise use is made of the administration of adenosine or regadenoson. - Patients taking preventive use of PPIs. - Patients who have signed an informed consent. - Patients taking PPIs for longer than two weeks. - the scan is accomplished on the BrightView 1 in Nucleare department Rijnstate Arnhem. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - myocardial perfusion stress test performed with a bycycle ergometry. - Patients with dyspepsia. - Patients with only uptake in the stomach cavity. - Patients who are not prepared and tested in accordance with the protocols in the hospital Rijnstate. - Patients with the following well-known diseases, Zollinger Ellison Syndrome, a barrettoesofagus or a esophagitis with endoscopic grade C or D. - Patients who are(partially) paravasal injected. - Possible complications with concomitant medications.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: End of Oktober 2016;Main Objective: The goal is to acquire knowledge about the impact of the withdrawal of PPIs, so as to minimize disturbance of uptake in the stomach wall in myocardial perfusion imaging. The associated main question here came about: What is the effect of the withdrawal of PPI in the stomach wall uptake with 99m Tc-Sestamibi in myocardial perfusion imaging? Myocardial perfusion imaging consists of stress and rest study. Main question: What is the effect of the withdrawal of PPI in the stomach wall uptake with 99m Tc-Sestamibi in myocardial perfusion imaging? Sub-questions: - What is the relative stomach wall uptake within myocardial perfusion imaging Tc 99m Sestamibi in the stress an rest studies? - How can withdrawal of PPI’s gain effect on the image quality and the ability to assess a myocardial perfusion imaging? Hypothesis It is expected that reducing and eventually stopping PPIs for myocardial perfusion imaging shows an equivalent image in patients not taking PPIs.;Primary end point(s): It has previously been shown that the use of stomach protective drugs also called proton pump inhibitors (PPIs), the uptake of the radiopharmaceutical Tc99m Sestamibi increases in the stomach wall in a cardiac function (myocardial perfusion) examination. The higher the uptake in the stomach wall, the more negative this contributes to the evaluation of the heart. It can lead to the poor judging of the perfusion (blood flow) of the heart. By reducing the use of PPI’s for a myocardial perfusion examination this issue would maybe be reduced and the quality of care improved. Previously, no research has been conducted into the impact of the withdrawal of PPIs with a myocardial perfusion imaging. It has previously been shown that patients who used PPI’s have much uptake in the stomach and patients not taking PPI’s have virtually no uptake in the stomach wall. The goal is to acquire

Secondary

MeasureTime frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -

Countries

Netherlands

Contacts

Public ContactNucleair Medicine

Rijnstate Ziekenhuis

0031880056067

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026