Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

NCT04022395 | Completed

• 1 other identifier: 519REG2016
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Efficacy of stress cMRI

  24 month

• Incidence of Treatment-Emergent Adverse Events

  24 month

Study Arms (1)

stress cardiac MRI

EXPERIMENTAL

* 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

Diagnostic Test: stress cardiac MRI

Interventions

stress cardiac MRI DIAGNOSTIC_TEST

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

stress cardiac MRI

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

Istituto Giannina Gaslini

Genova, 16100, Italy

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator, Radiology Dept, Cardiovascular MRI Team

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: July 17, 2019
• Study Start: October 18, 2018
• Primary Completion: February 28, 2021
• Study Completion: March 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)