Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

Concordance Between Stress CMR and Coronary Angiography in Pediatric Patients With Suspected Coronary Artery Disease

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

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Diagnostic test: stress cardiac MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16100
    • Istituto Giannina Gaslini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Diagnostic test: stress cardiac MRI; pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Incidence of Treatment-Emergent Adverse Events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	24 month

Collaborators and Investigators

• Sponsor: Istituto Giannina Gaslini

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: July 13, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 519REG2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No