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Gadobutrol Enhanced MRA of the Supra-aortic Vessels (GEMSAV)

10 dicembre 2018 aggiornato da: Bayer

Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

479

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
    • Buenos Aires
      • Adrogué, Buenos Aires, Argentina, B1846DWA
    • Ciudad Auton. De Buenos Aires
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1115AAB
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425BEE
  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Parkville, Victoria, Australia, 3052
  • Austria
      • Wien, Austria, 1090
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Cechia
      • Brno, Cechia, 62500
  • Cina
      • Shanghai, Cina, 200032
      • Shanghai, Cina, 200433
  • Corea, Repubblica di
      • Seoul, Corea, Repubblica di, 05505
      • Seoul, Corea, Repubblica di, 06351
      • Seoul, Corea, Repubblica di, 03722
    • Gwangju Gwang''yeogsi
      • Donggu,, Gwangju Gwang''yeogsi, Corea, Repubblica di, 61469
  • Francia
      • BRON Cedex, Francia, 69677
      • Brest Cedex, Francia, 29609
      • Marseille, Francia, 13385
      • Paris, Francia, 75877
      • Paris Cedex 15, Francia, 75908
  • Germania
    • Baden-Württemberg
      • Karlsruhe, Baden-Württemberg, Germania, 76133
    • Bayern
      • Augsburg, Bayern, Germania, 865156
      • Erlangen, Bayern, Germania, 91054
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germania, 48145
    • Thüringen
      • Jena, Thüringen, Germania, 07740
  • Italia
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italia, 44023
    • Lazio
      • Roma, Lazio, Italia, 00168
    • Sicilia
      • Catania, Sicilia, Italia, 95123
    • Toscana
      • Massa-Carrara, Toscana, Italia, 54100
    • Valle d'Aosta
      • Aosta, Valle d'Aosta, Italia, 11100
    • Veneto
      • Venezia, Veneto, Italia, 30174
  • Polonia
      • Bydgoszcz, Polonia, 85-094
      • Lodz, Polonia, 90-153
      • Warszawa, Polonia, 02-097
      • Wroclaw, Polonia, 50-556
  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85724
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32209
    • Georgia
      • Savannah, Georgia, Stati Uniti, 31406
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109-0330
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39216
    • New York
      • Bronx, New York, Stati Uniti, 10467
      • Rochester, New York, Stati Uniti, 14642
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38104
    • Washington
      • Seattle, Washington, Stati Uniti, 98195
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792
  • Svezia
      • Linköping, Svezia, 581 85
      • Uppsala, Svezia, 751 85
  • Svizzera
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Svizzera, 9007
  • Tacchino
      • Antalya, Tacchino, 07059
      • Erzurum, Tacchino, 25240
      • Istanbul, Tacchino, 34093

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Male or female subjects, aged 18 years and older

  • Any of the following:

    • Known or suspected supra-aortic arterial disease based on:

      • Prior stroke
      • Transient ischemic attack (TIA)
      • Amaurosis Fugax (transient monocular blindness)
    • Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
    • Follow-up for a stent in a supra-aortic vessel
    • Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints.
  • Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
  • Willingness and ability to follow directions and complete all study procedures specified in the protocol
  • Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug

Exclusion Criteria:

  • Pregnant or nursing (including pumping for storage and feeding)
  • Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
  • Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
  • Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
  • Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
  • History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
  • Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
  • Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
  • Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
  • Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
  • Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)

  • Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:

    • Any procedure that may alter the MRA or CTA interpretation, or
    • Any interventional or surgical procedure involving the supra-aortic vessels

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Braccio 1
Droga: Gadobutrol (Gadovist, BAY86-4875)
A single bolus injection of approx. 0.1mmol/kg

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Lasso di tempo: Images were taken pre-injection and post-injection
Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.
Images were taken pre-injection and post-injection
Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Lasso di tempo: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Images were taken pre-injection and post-injection
Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Lasso di tempo: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Images were taken pre-injection and post-injection
Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%
Lasso di tempo: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
Images were taken pre-injection and post-injection
Minimum Gadobutrol Performance for Specificity: Specificity > 50%
Lasso di tempo: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
Images were taken pre-injection and post-injection

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
La percentuale di segmenti con presenza di artefatti
Lasso di tempo: Le immagini sono state scattate prima e dopo l'iniezione
Gli artefatti sono stati raccolti per le immagini MRA su base segmentale.
Le immagini sono state scattate prima e dopo l'iniezione
Tipi di studi di imaging aggiuntivi raccomandati dall'investigatore clinico dopo la valutazione delle immagini MRA non potenziate e potenziate con gadobutrolo
Lasso di tempo: Le immagini sono state scattate prima e dopo l'iniezione
Uno studio di imaging aggiuntivo raccomandato è stato specificato dal seguente elenco: MRA senza mezzo di contrasto, MRA con mezzo di contrasto, CTA, ecografia, angiogramma con catetere a sottrazione digitale (DSCA) e studio di medicina nucleare.
Le immagini sono state scattate prima e dopo l'iniezione
Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
Lasso di tempo: Images were taken pre-injection and post-injection
The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).
Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 1
Lasso di tempo: Images were taken pre-injection and post-injection
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 2
Lasso di tempo: Images were taken pre-injection and post-injection
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 3
Lasso di tempo: Images were taken pre-injection and post-injection
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Images were taken pre-injection and post-injection
The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Lasso di tempo: Images were taken pre-injection and post-injection
Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.
Images were taken pre-injection and post-injection
Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Lasso di tempo: Images were taken pre-injection and post-injection
The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%. If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated. If there was no stenosis of >=70% in a segment then the length was designated as 0.
Images were taken pre-injection and post-injection
The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Lasso di tempo: Images were taken pre-injection and post-injection
Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present.
Images were taken pre-injection and post-injection
Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Lasso di tempo: Images were taken pre-injection and post-injection
Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present. If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.
Images were taken pre-injection and post-injection
Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Lasso di tempo: Images were taken pre-injection and post-injection
Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1 = Not confident, 2 = Somewhat confident, 3 = Confident, and 4 = Very confident.
Images were taken pre-injection and post-injection
The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
Lasso di tempo: Images were taken pre-injection and post-injection
A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.
Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1
Lasso di tempo: Images were taken pre-injection and post-injection
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2
Lasso di tempo: Images were taken pre-injection and post-injection
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3
Lasso di tempo: Images were taken pre-injection and post-injection
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Images were taken pre-injection and post-injection

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bayer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 maggio 2011

Completamento primario (Effettivo)

28 maggio 2014

Completamento dello studio (Effettivo)

28 maggio 2014

Date di iscrizione allo studio

Primo inviato

5 aprile 2011

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2011

Primo Inserito (Stima)

29 aprile 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 gennaio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 dicembre 2018

Ultimo verificato

1 dicembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 14607
  • 2010-023001-36 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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