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Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

Primary Purpose

Coronary Disease

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

stress cardiac MRI

About this trial

This is an interventional diagnostic trial for Coronary Disease

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istituto Giannina Gaslini

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stress cardiac MRI

Arm Description

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

Outcomes

Primary Outcome Measures

Multiparameters diagnostic concordance

• Agreement of results between stress cMRI and the current practice constituted by Exercise test, Stress Cardiac Ultrasound and Invasive Angiography

Secondary Outcome Measures

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

Incidence of Treatment-Emergent Adverse Events

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

NCT ID

NCT04022395

First Posted

March 15, 2019

Last Updated

September 6, 2021

Sponsor

Istituto Giannina Gaslini

1. Study Identification

Unique Protocol Identification Number

NCT04022395

Brief Title

Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

October 18, 2018 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituto Giannina Gaslini

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stress cardiac MRI

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

stress cardiac MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

Multiparameters diagnostic concordance

Description

• Agreement of results between stress cMRI and the current practice constituted by Exercise test, Stress Cardiac Ultrasound and Invasive Angiography

Time Frame

24 month

Secondary Outcome Measure Information:

Title

Efficacy of stress cMRI

Description

Time Frame

24 month

Title

Incidence of Treatment-Emergent Adverse Events

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

24 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Istituto Giannina Gaslini

City

Genova

ZIP/Postal Code

16100

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

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Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease

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