Clinical trial NCT04022395: Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease
Official title: Concordance Between Stress CMR and Coronary Angiography in Pediatric Patients With Suspected Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Lead sponsor: Istituto Giannina Gaslini
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 the patient, but with the advantage of non-invasiveness and lack of radiation, and less laborious for the participants

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 coronary arteries origin and proximal pathway, wall motion abnormalities, myocardial perfusion and viability, enabling accurate monitoring of symptomatic and non-pediatric patients. Investigators would build a prospective series of stress cMRI exams in pediatric symptomatic and non-patients, with suspected or previously diagnosed coronary artery disease. Investigators would put the results in comparison with ECG, Exercise test, stress Cardiac Ultrasound and Angiography. At the end of the study, if supported by results, the aim is to replace the current diagnostic procedure (ECG, Exercise test, stress Cardiac Ultrasound and Angiography) which need long hospitalization, expose the patient to radiation dose, is uncomfortable for the patient, and is characterized by a non-negligible risk due to invasive procedure, with a single exam (stress cMRI) which is dose-free, minimal risk related, without hospitalization, and less expensive for National Care System.

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

Primary outcomes:
measure: Multiparameters diagnostic concordance
timeFrame: 24 month
Secondary outcomes:
measure: Efficacy of stress cMRI
timeFrame: 24 month
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 24 month
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
Study officials:
References: