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    Summary
    EudraCT Number:2014-000681-22
    Sponsor's Protocol Code Number:VIS-13-08
    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:2014-10-08
    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 number2014-000681-22
    A.3Full title of the trial
    EFFECT OF ISO-OSMOLAR CONTRAST MEDIUM ON CORONARY OPACIFICATION AND HEART RHYTHM IN CORONARY CT ANGIOGRAPHY (ISO-COR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF CONTRAST MEDIUM ON CORONARY OPACIFICATION AND HEART RHYTHM IN CORONARY CT's (ICO-COR)
    A.3.2Name or abbreviated title of the trial where available
    ISOCOR
    A.4.1Sponsor's protocol code numberVIS-13-08
    A.5.4Other Identifiers
    Name:CCMONumber:NL46493.078.13
    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 SponsorErasmusMC
    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 supportErasmusMC
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportGE
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmusMC
    B.5.2Functional name of contact pointtrial coordinator
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal
    B.5.3.2Town/ cityrotterdam
    B.5.3.3Post code3015ce
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31107033612
    B.5.6E-mailimaging.trialbureau@erasmusmc.nl
    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 Visipaque
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare B.V>
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameVisipaque
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 typeContrast agent
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ultravist
    D.2.1.1.2Name of the Marketing Authorisation holderBayer-Schering
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameUltravist 300
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 typeContrast agent
    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
    Patients with suspected coronary artery disease and clinically referred for coronary CTA.
    E.1.1.1Medical condition in easily understood language
    Patients with possible heart disease
    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
    Demonstrate that with contemporary cardiac CT scan protocols good opacification of the coronary arteries can be achieved, that is similar to low-osmolar contrast media injected at the same iodine delivery rate.
    E.2.2Secondary objectives of the trial
    investigate the effect of iso-osmolar contrast media on heart rate and variability in relation to image quality.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age >18 yrs
    • Body weight 50 – 125 kg
    E.4Principal exclusion criteria
    • Pregnancy
    • Renal dysfunction defined as eGFR<45 ml/min
    • Allergies to iodine contrast media, manifest thyreotoxicosis
    • Arrhythmia, including atrial fibrillation/flutter, 2nd or 3rd degree AV block, frequent ectopic beats prior to the exam (discretion of the referrer).
    • Prior coronary artery bypass graft surgery or coronary stents
    • Contraindications to the contrast media according to SPC (summary of product characteristics)
    E.5 End points
    E.5.1Primary end point(s)
    Intra-coronary opacification: i.e. the mid-coronary lumen attenuation expressed in Hounsfield Units (HU), primary endpoint, demonstrating non-inferiority.
    Mean attenuation measured in the mid LAD (7), proximal LCX (11) and mid RCA (2), averaged per patient. Requirements:
    • Vessel: minimal diameter 2 mm, good or moderate image quality.
    • ROI size: circular shape, minimum 50 pixels per sample.
    • ROI placement: axial images, center of the vessel, optimal image quality,
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the last included patient' scan is performed
    E.5.2Secondary end point(s)
    Quantitative and qualitative image quality
    • Differential contrast attenuation: proximal, mid, distal coronary arteries.
    • Signal to noise (attenuation versus SD) and contrast to noise ratios (difference between coronary and myocardium versus myocardium).
    • Subjective image quality of the coronary arteries on a 3-point scale: good, diagnostic, poor.
    • Image artifacts, categorized per segment
    • Contrast plateau characteristics: enhancement throughout the vasculature from systemic venous system to the descending aorta and myocardium.

    Cardiovascular effects
    • Heart rate before scan (mean over 15s); during calcium score (mean over heart cycles during scan); during CTA (mean over heart cycles during scan).
    • Number of ectopic beats throughout the ECG recording during and after contrast injection.
    • Heart rate variability (variance to the mean RR duration)
    • Occurrence of atrial fibrillation.

    Contrast injection parameters
    • Injection characteristics: accomplished flow rates, resistance, etc.
    • Clinical effect: patient discomfort at the injection site and adverse events, contrast reactions, nausea, etc.
    • Contrast delivery parameters (Certega box):
    • Injection rate and pressure

    Clinical safety
    • Contrast extravasation (binary).
    • Severe arrhythmia, with hemodynamical significance.
    • Allergic reactions
    • Renal failure
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the last included patient' scan is performed
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Contast agent
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    the duration of study participation is limited to the time of the CT scan. The scan itself is similar to a routine clinical scan, without additional risk or discomfort. Both contrast media are registered and considered equally safe. The burden of the study is limited to the time spend discussing the study an dreading the patient information. The results of the study may benefit future patients in a similar situation, and can only be performed in this specific group (group related).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-10-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state300
    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, the burden of the study is limited to the time spend discussing the study an dreading the patient information. The results of the study may benefit future patients in a similar situation, and can only be performed in this specific group (group related).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ErasmusMC
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Maasstad Ziekenhuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Albert Schweitzer Ziekenhuis
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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