Status:
COMPLETED
Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease
Lead Sponsor:
Istituto Giannina Gaslini
Conditions:
Coronary Disease
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
stress cMRI with Dobutamine stress agent (stress cMRI), represent the combination of two orders of exams routinely performed (cMRI and stress diagnostic series of exams) without additional risk for th...
Detailed Description
Surgical revascularization or angioplasty are therapeutic options for coronary lesions even in infants and children. Pharmacological stress induced cMRI could provide crucial information such as coron...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04022395
Start Date
October 18 2018
End Date
March 30 2021
Last Update
September 8 2021
Active Locations (1)
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1
Istituto Giannina Gaslini
Genova, Italy, 16100