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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stress cardiac MRI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stress cardiac MRI | Diagnostic Test | pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia |
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| Measure | Description | Time Frame |
|---|---|---|
| Multiparameters diagnostic concordance | • Agreement of results between stress cMRI and the current practice constituted by Exercise test, Stress Cardiac Ultrasound and Invasive Angiography | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of stress cMRI | Predictive value of stress cMRI to determine the incidence of post-surgical complication of switch repair, and other pathological conditions affecting coronary arteries in natural history, in comparison with tradition test. This will be measured the number coronary segments affected, and consequences on wall motion abnormalities | 24 month |
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Inclusion Criteria:
Between 8 and 18 years-old patients symptomatic and non, with suspected or previously diagnosed coronary arteries disease
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),
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Giannina Gaslini | Genova | 16100 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2017 | Jul 16, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Incidence of Treatment-Emergent Adverse Events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 24 month |