Assessment of the quality of images acquired from scanner of coronary arteries

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2010-021826-37-ES
• Date of registration: 12/01/2012
• Prospective Registration: No
• Primary sponsor: GUERBET
• Public title: Assessment of the quality of images acquired from scanner of coronary arteries
• Scientific title: Xenetix 350 : Evaluación comparativa de la calidad de imagen en la angiografía de las arterias coronarias mediante escáner Xenetix 350 : comparative assessment of image quality for coronary CT angiography - X-ACT study
• Date of first enrolment: 18/08/2011
• Target sample size: 466
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021826-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

France, Germany, Italy, Spain

Contacts

• Name: Head of Medical Affairs
• Affiliation: GUERBET

• Name: Head of Medical Affairs
• Affiliation: GUERBET

Key inclusion & exclusion criteria

Inclusion criteria:
.· paciente Masculino o femenino adulto (habiendo alcanzado edad legal de mayoría).
· paciente Sintomático sospechado para enfermedad de arteria coronaria (DAO) previsto para TC angiografia coronaria.
· el paciente femenino debe tener un método de contracepción eficaz (la píldora anticonceptiva o el Dispositivo Intrauterino), o esterilizada quirúrgicamente, o menopáusica (12 meses de amenorrea como mínimo o debe tener una prueba de embarazo de orina documentada negativa en la selección.
· Paciente con seguro médico (según las exigencias locales).
· Paciente capaz de comprender la información facilitada y que haya firmado el consentimiento informado para participar en el ensayo .
· · Male or female adult patient (having reached legal majority age).
· Symptomatic patient suspected for coronary artery disease (CAD) scheduled for a coronary CT angiography.
· Female patient must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12months of amenorrhea) or must have a documented negative urine pregnancy test at screening.Patient with health insurance (according to the local regulatory requirements).
· Patient able to understand and having provided written informed consent to participate in the trial.
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 116

Exclusion criteria:
· · el Paciente con una frecuencia cardiaca > 65 latidos por minuto (lpm) y la contraindicación o la intolerancia a los betabloqueadores.
· Paciente con aritmia o ritmo cardiaco no sinusal.
· Paciente incapaz de contener la respiración.
· Paciente con insuficiencia cardiaca descompensada.
· Paciente con inestabilidad clínica probada activa o en curso (infarto de miocardio agudo sospechado o conocido, shock cardiaco, edema pulmonar agudo).
·
· Paciente con válvula cardiaca artificial.
· Paciente con estenosis aórtica moderada o intensa conocida.
· Paciente con hipertiroidismo conocido (hormona estimulante del tiroides <0.3 mU/L).
Paciente con antecedentes de reacciones de hipersensibilidad inmediata o tardía al producto en investigación
· Paciente que hayan recibido o deba recibir un medio de contrate yodado en las 48 horas previas a la exploración radiológica.
· Paciente que presente insuficiencia renal grave conocida (elevada creatinina sérica (> 1.5 mg/dl o> 120 µ mol/l) o aclaramiento de creatinina estimada <30 ml/min calculada por la fórmula de Cockcroft y Gault o una tasa de filtración glomerular de <30ml/min/1.73m ²).
· Paciente incluido en este estudio o que haya participado en los 30 días previos en otro ensayo clínico sobre un producto médico en investigación

Toda situación que, según el criterio clínico del investigador, impida al paciente realizar todas las evaluaciones y visitas del estudio (p. ej., incapacidad mental o física, incomprensión del idioma, localización geográfica, etc.)
- Paciente bajo tutela o cuya cooperación sea incompatible con el desarrollo del estudio
- Paciente embarazada o lactante

Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration.
· Patient with arrhythmia or non-sinus rhythm.
· Patient unable to sustain breath hold.
· Patient with decompensated heart failure.
· Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema).
· Patient who has previously undergone coronary artery bypass graft (CABG).
· Patient who has previously undergone percutaneous transluminal coronary stent placement.
· Patient with artificial heart valve.
· Patient with known moderate to severe aortic stenosis.
· Patient with known hyperthyreosis (thyroid-stimulating hormone < 0.3 mU/L).
· Patient with known severe adverse drug reaction or contraindication to the investigational product or comparator.
· Patient having received any MR or X-Ray contrast media within 48 hours prior to administration of investigational product or comparator.
· Patient presenting with known severe renal failure (elevated serum creatinine (> 1.5 mg/dl or > 120µmol/l) or estimated creatinine clearance < 30 ml/min as calculated by the Cockcroft and Gault formula or e-GFR < 30ml/min/1.73m²).
· Patient previously included in this trial or having participated in any investigational drug study within 30 days prior the study enrolment or included in another clinical trial involving an Investigational Medicinal Product (IMP).
· Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits (e.g.: mental or physical incapacity, language comprehension, geographical localisation, etc?).
· Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial.
· Breas

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pacientes sintomáticos con sospecha de enfermedad de arteria coronaria programado para escaner de angiografia coronaria . Symptomatic patients suspected for coronary artery disease scheduled for a coronary CT angiography.
MedDRA version: 14.1 Level: LLT Classification code 10060808 Term: Computerized tomogram coronary artery System Organ Class: 10022891 - Investigations

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: XENETIX 350 mg/ml solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOBITRIDOL
Other descriptive name: IOBITRIDOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 767.8-

Trade Name: ULTRAVIST 370 mg/ml solución inyectable y para perfusión en vial
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOPROMIDA
CAS Number: 73334-07-3
Other descriptive name: IOPROMIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 767.8-

Trade Name: IOMERON 400
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOMEPROL
CAS Number: 78649-41-9
Other descriptive name: IOMEPROL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 816-

Primary Outcome(s)

Primary end point(s): Evaluabilidad de del escáner de TC valoradas en 18 segmentos coronarios de la segmentación coronaria TCCS, utilizando una escala de evaluación de 5 puntos que clasifica la calidad y la interpretabilidad de las imágenes (la mayor duda sobre la presencia/ausencia de estenosis) a excelente (ninguna duda sobre la presencia/ausencia de estenosis).
De la evaluación de nivel de segmento, TC estará dedefinido como la proporción de pacientes que se presentan con segmentos de no diagnóstico (excepto segmentos ocluidos)

Evaluability of CT scans based upon the assessment of 18 segments from the SCCT coronary segmentation, using a 5-point evaluation scale grading the quality and the interpretability of images from non-diagnostic (major doubts about presence/absence of stenosis) to excellent (not any doubts about presence/absence of stenosis).
From the segment-level assessment, CT scan evaluability will defined as the proportion of patients presenting with no non-diagnostic segments (except occluded segments)

Secondary Objective: Comparar los tres medios de contraste sobre varios parámetros de eficacia cualitativos y cuantitativos (la calidad de imagen, detección de estenosis, cuantificación de la señal, exploración automática de coronarias, puntuación de calcio, Irradiación, la comodidad paciente y el tratamiento).

- Comparar la tolerancia clínica y electrocardiografica de los tres medios de comunicación de contraste.- To compare the three contrast media on several qualitative and quantitative efficacy parameters (image quality, stenosis assessment, signal quantification, coronary track rate, calcium scoring, radiation dose, patient comfort and management).

- To compare the clinical and electrocardiographic tolerance of the three contrast media.

Timepoint(s) of evaluation of this end point: After CT acquisition - images assessment performed by 2 off-site readers

Main Objective: Demostrar la no inferioridad estadística de Xenetix ® 350 comparado a Ultravist ® 370 y Iomeron ® 400 cuando se utiliza para evaluar en tomografia computerizada de arteria coronaria (la calidad e interpretabildad de imágenes)
To demonstrate the statistical non-inferiority of Xenetix® 350 compared to Ultravist® 370 and Iomeron® 400 when used in coronary angiography in terms of CT scan evaluability (quality and interpretability of images).

Secondary Outcome(s)

Secondary end point(s): Comparison of the three contrast media on several qualitative and quantitative efficacy and safety parameters

Timepoint(s) of evaluation of this end point: After CT acquisition - on-site & off-site assessments

Secondary ID(s)

ISO-44-012

2010-021826-37-FR

Source(s) of Monetary Support

GUERBET

Ethics review

Status: Approved
Approval date: 07/06/2011
Contact:

Results

• Results available: Yes
• Date Posted: 14/10/2017
• Date Completed: 17/09/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-021826-37/results