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

Phase 1

• 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.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-001383-10-NL
• Lead Sponsor: Rijnstate ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-27
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified