Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT04022395
Eligibility Criteria:
Inclusion Criteria:
* Between 8 and 18 years-old patients symptomatic and non, with suspected or previously diagnosed coronary arteries disease
* Coronary artery re-implantation after arterial switch
* ALCAPA Syndrome, and other anomalies of origin or pathway
* replacement of aortica valve with pulmonary autograft (Ross procedure)
* Kawasaki disease
* primary dilatative cardiomyopathy
* coronary atresia
* familiar Hypercholesterolemia
* bicuspid aortic valve
* chest pain
* exertional dyspnea of suspected coronary artery nature
* coronary artery fistula
Exclusion Criteria:
* General contraindication to MRI (non MRI compatible device: vascular clips, foreign bodies, coronary and peripheral artery stents, aortic stent grafts, prosthetic heart valves and annuloplasty rings, cardiac occluder devices, vena cava filters and embolisation coils, haemodynamic monitoring and temporary pacing devices, haemodynamic support devices, permanent cardiac pacemakers and implantable cardioverter-defibrillators, retained transvenous pacemaker and defibrillator leads, cochlear implants, claustrophobia, pregnancy and postpartum),
* contraindication to contrast agent (renal insufficiency, hypersensitivity to the Dotarem active substance or to any of the excipients:)
* contraindication to stress agent (hypersensitivity to Dobutamine active substance or to any of the excipients)
* severe arterial hypertension (\>/= 220/120 mmHg)
* unstable angina pectoris
* significant aortic stenosis
* complex cardiac arrhythmias including uncontrolled atrial fibrillation
* hypertrophic obstructive cardiomyopathy
* myocarditis, endocerditis
* pericarditis
* uncontrolled congestive heart failure
* previous manifestations of hypersensitivity to dobutamine
* refuse to join the protocol and relative off-label procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT04022395
Study Brief:
Protocol Section:
NCT04022395