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出境医 / 临床实验 / Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

Study Description
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

Condition or disease Intervention/treatment Phase
Coronary Disease Diagnostic Test: stress cardiac MRI Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Concordance Between Stress CMR and Coronary Angiography in Pediatric Patients With Suspected Coronary Artery Disease
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 30, 2021
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Multiparameters diagnostic concordance [ Time Frame: 24 month ]
    • Agreement of results between stress cMRI and the current practice constituted by Exercise test, Stress Cardiac Ultrasound and Invasive Angiography


Secondary Outcome Measures :
  1. Efficacy of stress cMRI [ Time Frame: 24 month ]
    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

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 24 month ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Nicola Stagnaro +393383929093 nicolastagnaro@gaslini.org

Locations
Layout table for location information
Italy
Istituto Giannina Gaslini Recruiting
Genova, Italy, 16100
Contact: Nicola Stagnaro, MD         
Sponsors and Collaborators
Istituto Giannina Gaslini
Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE October 18, 2018
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2019) 		Multiparameters diagnostic concordance [ Time Frame: 24 month ]
• Agreement of results between stress cMRI and the current practice constituted by Exercise test, Stress Cardiac Ultrasound and Invasive Angiography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Efficacy of stress cMRI [ Time Frame: 24 month ]
    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
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 24 month ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • Efficacy of stress cMRI [ Time Frame: 24 month ]
    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
  • Safety [ Time Frame: 24 month ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease
Official Title  ICMJE Concordance Between Stress CMR and Coronary Angiography in Pediatric Patients With Suspected Coronary Artery Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Disease
Intervention  ICMJE Diagnostic Test: stress cardiac MRI
pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia
Study Arms  ICMJE 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
Intervention: Diagnostic Test: stress cardiac MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicola Stagnaro +393383929093 nicolastagnaro@gaslini.org
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022395
Other Study ID Numbers  ICMJE 519REG2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicola Stagnaro, Istituto Giannina Gaslini
Study Sponsor  ICMJE Istituto Giannina Gaslini
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istituto Giannina Gaslini
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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