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

Phase 1

• Conditions: 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: 14.1Level: LLTClassification code 10060808Term: Computerized tomogram coronary arterySystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-021826-37-ES
• Lead Sponsor: GUERBET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-12
• Study Completion: 2012-09-17
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 466

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

Study & Design

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