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Completed

NCT Number: NCT04022395

Stress CMR 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

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Giannina Gaslini

Genova, 16100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stress cardiac MRI

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Istituto Giannina Gaslini

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2019
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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