Concordance Between Stress CMR and Coronary Angiography in Pediatric Patients With Suspected Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Multiparameters diagnostic concordance
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Multiparameters diagnostic concordance
时间窗: 24 month
• Agreement of results between stress cMRI and the current practice constituted by Exercise test, Stress Cardiac Ultrasound and Invasive Angiography
次要结局
- Incidence of Treatment-Emergent Adverse Events(24 month)
- Efficacy of stress cMRI(24 month)
研究者
Nicola Stagnaro
MD, Principal Investigator, Radiology Dept, Cardiovascular MRI Team
Istituto Giannina Gaslini