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    Summary
    EudraCT Number:2016-001383-10
    Sponsor's Protocol Code Number:57340
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-001383-10
    A.3Full title of the trial
    Evaluating the effect of short term withdrawal of PPI's in patients for reducing stomach wall uptake with 99mTc Sestamibi for myocardial perfusion imaging
    Het afbouwen van PPI (Proton Pump Inhibitor) gebruik, van zowel mannen als vrouwen, ter vermindering van de maagwand uptake van 99mTc Sestamibi bij een myocardperfusiescintigrafie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of withdrawal of PPI use for myocardial perfusion imaging.
    Invloed van afbouwen van PPI bij een myocardperfusiescintigrafie.
    A.4.1Sponsor's protocol code number57340
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRijnstate ziekenhuis
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRijnstate Ziekenhuis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRijnstate Ziekenhuis
    B.5.2Functional name of contact pointNucleair Medicine
    B.5.3 Address:
    B.5.3.1Street AddressWagnerlaan 55
    B.5.3.2Town/ cityArnhem
    B.5.3.3Post code6815AD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031880056067
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Omeprazole ATC code: A02BC01 Pantoprazole ATC code: A02BD04 Esomeprazole ATC code: A02BC05
    D.2.1.1.2Name of the Marketing Authorisation holderVaries
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameProton Pump Inhibitors
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeProton Pump inhibitor
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    E.1.1.1Medical condition in easily understood language
    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.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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 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.

    The study is a prospective controlled trial study. During the study men and women are divided into four intervention groups. Men are divided into two intervention groups, women as well. For men shall be in one of the two intervention groups, PPI’s will be stopped for the stress examination and continued for the rest examination. The other intervention is the continuation of PPI’s in the stress examination and PPI’s are stopped in the rest examination. For woman held similar intervention groups. For each treatment group, 20 healthy participants are required. In and exclusion criteria are specified later.

    With this study, the care of the patient may be improved. Any other additional repeat examination can be reduced. In addition, costs can be reduced regarded to the use of medication. Better images are provided to professionals to be reviewed which leads to a better treatment for the patient. 
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Oktober 2016
    E.5.2Secondary end point(s)
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial80
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Wenn all data is analysed and processed.
    A rapport has been written.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-04
    P. End of Trial
    P.End of Trial StatusOngoing
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