Xenetix 350 : comparative assessment of image quality for coronary CT angiography - X-ACT study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 466

Inclusion Criteria

· 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· 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.
· Breast feeding or pregnant patient.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 10/8/2021