Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

NCT ID: NCT04022395

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2021-03-30

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.

Conditions

Coronary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

stress cardiac MRI

• To optimize the scan protocol and the sequence parameters
• To investigate the clinical compliance of stress induced cardiac MRI in pediatric patients
• To test the ability of stress cMRI to visualize coronary arteries morphological irregularities, the corresponding wall motion abnormalities and perfusion - viability features

Group Type: EXPERIMENTAL

stress cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia

Interventions

stress cardiac MRI

pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Giannina Gaslini

OTHER

Sponsor Role: lead

Responsible Party

Nicola Stagnaro

MD, Principal Investigator, Radiology Dept, Cardiovascular MRI Team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istituto Giannina Gaslini

Genova, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

519REG2016

Identifier Type: -

Identifier Source: org_study_id