Clinical Trials Logo

Clinical Trial Summary

Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.


Clinical Trial Description

This was a Phase III, multicenter, open-label study that was to be conducted at approximately 7-12 sites in the United States, Canada and Europe in pediatric patients with suboptimal LV EBD on non-contrast 2D transthoracic echocardiography. It was estimated that 92 patients were to be enrolled to provide 73 evaluable patients.

Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile were to independently evaluate the echocardiograms. The efficacy analysis was primarily based on the blinded reader evaluations.

Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.

One of the sites participating in this study was to be asked to consent a subset of patients for additional blood sampling for analysis of SF6 concentration in blood from a total of 6 patients (3 males and 3 females) in the age group 9 up to 12 years of age and 6 patients (3 males and 3 females) in the age of >12 up to and including 17 years.

The current study was designed to assess the efficacy of Lumason-enhanced echocardiography in pediatric patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02282163
Study type Interventional
Source Bracco Diagnostics, Inc
Contact
Status Terminated
Phase Phase 3
Start date October 2015
Completion date August 2018

See also
  Status Clinical Trial Phase
Completed NCT03481322 - Low Sodium Cooking Study N/A
Completed NCT00001638 - Magnetic Resonance Imaging of the Blood Vessels of the Heart
Completed NCT02376244 - The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation N/A
Completed NCT02523144 - Dexmedetomidine in Children Having Transthoracic Echocardiography Phase 4
Completed NCT02277379 - Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Completed NCT02045641 - Pleural and Pericardial Effusion Following Open Heart Surgery N/A
Active, not recruiting NCT01400490 - Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study N/A
Completed NCT01192360 - Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease Phase 3
Terminated NCT00935766 - Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries Phase 3
Completed NCT00745446 - The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation N/A
Completed NCT00140816 - Dairy Products and Metabolic Effects (Norwegian Part) N/A
Completed NCT00178620 - Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization Phase 4
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Completed NCT01952171 - The Genetic Basis of Congenital Heart Disease in Africa
Recruiting NCT02933892 - Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization Phase 4
Completed NCT02923518 - Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Withdrawn NCT02838355 - Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients N/A
Active, not recruiting NCT02260466 - Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement. N/A
Completed NCT02274220 - Feeding Study - Effects Post-cardiac Surgery N/A