Authorised Phase I and Phase II (Integrated)- Other Patients who need to undergo a clinically indicated pharmacologic stress perfusion CMR test and who are considered fit for a pharmacological stress perfusion CMR by the investigator. The pharmacologic stress perfusion CMR may be performed in patients for further evaluation of cardiovascular conditions or diseases, such as, but not limited to, Kawasaki disease, congenital heart diseases, congenital coronary abnormalities, and post-cardiac surgery / transplantation, etc.

A clinical trial to be conducted in many hospitals and in different countries with the medicinal substance Regadenoson to be used in a type of heart scan called 'radionuclide myocardial perfusion imaging' to see the blood flow in the heart muscle in patients aged between 1 month - 18 years.

EU CTIS ID: 2024-515244-22-00

What this study is testing

1. To evaluate the safety and tolerability of a single, body-weight adjusted intravenous (i.v.) bolus dose of regadenoson in paediatric patients aged 2 to <18 years and who weigh at least 6 kg. 2. To characterise the pharmacokinetics (PK) of a single, body-weight adjusted i.v. dose of regadenoson and the effects on heart rate (HR) in 2 paediatric populations: adolescents aged 12 to <18 years and children aged 2 to <12 years.

  • Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Male or female patient aged 2 to <18 years. 2. Patient weighs at least 6 kg. 3. Patients who need to undergo a clinically indicated pharmacologic stress perfusion CMR test and who are considered fit for a pharmacological stress perfusion CMR by the investigator. The pharmacologic stress perfusion CMR may be performed in patients for further evaluation of cardiovascular conditions or diseases such as, but not limited to, Kawasaki disease, congenital heart diseases, congenital coronary abnormalities, and post-cardiac surgery/transplantation, etc. 4. Stable medication regimen for at least 7 days prior to dosing. Stable is defined as no addition, discontinuation, or change of any medications (or their doses) that could alter the rate-pressure product (HR × BP). 5. Patients and those whose parents or legally authorised representatives are, in the investigator’s view, likely to be compliant and complete the study will be eligible to participate. 6. Post-menarcheal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day. 7. Post-menarcheal female patients and male patients must be practicing abstinence or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study. 8. Parents or legally authorised representatives have signed the Informed Consent Form for this study approved by the Ethics Committee or the Institutional Review Board (IRB) for the patient to participate in the study indicating that the patient (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study, and, for patients who are able, have signed age-appropriate paediatric assent.

You likely can't join if

  • Patients must be excluded from participating in this study if they meet any of the following criteria: 1. Prior allergic reaction to Gd contrast agents and/or regadenoson or any component of its formulation or to aminophylline or to its components (ethylenediamine and theophylline). 2. Standard clinical contraindications to MRI as per institutional guidance, including patients with cochlear implants and implanted cardiac devices, or considered unfit for a pharmacologic stress perfusion CMR test by the investigator. 3. All patients will be screened for eGFR within 24 hours before the exam, and patients presenting with eGFR <30 mL/min/1.73 m2 (by the Schwartz formula) will be excluded. 4. Pregnant or lactating females or females of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test also required). 5. In the judgment of the investigator, any clinically significant ongoing medical condition (e.g., myocardial infarction, or unstable angina within 5 days, pericardial inflammatory disease, severe cardiac outflow tract obstruction, acutely decompensated heart failure, uncontrolled epilepsy, high risk for seizures, etc.) or clinically significant laboratory abnormality that is considered to potentially jeopardise the patient’s safety. 6. Patients with 2nd or 3rd degree atrioventricular block or sick sinus syndrome with or without an artificial pacemaker. 7. Known or suspected bronchoconstrictive and bronchospastic lung disease either being unstable or requiring active treatment (e.g., wheezing noted on physical exam, frequent exacerbations, or active treatment with a bronchodilator or corticosteroids). 8. Out of acceptable range sitting or semi-recumbent resting BP or HR (beats per minute [bpm]) at screening and dosing day as provided below: a) Acceptable range for BP (systolic / diastolic mmHg): 85 to 130 / 45 to 90 b) Acceptable range for HR: 55 to 100 bpm for 12 to <18 years old, and 60 to 120 bpm for 2 to <12 years old. 9. Use of any experimental or investigational drug or device within 30 days prior to dosing with study drug. 10. Consumption of methylxanthine-containing products such as caffeinated coffee, tea, caffeinated soft drinks, cocoa, or chocolate in the 48 hours prior to dosing. 11. Aminophylline or theophylline use within 24 hours, dipyridamole use within 48 hours prior to dosing. 12. History of alcohol abuse or drug addiction. 13. Positive urine drug screen at the screening visit, including amphetamines, barbiturates, cannabinoids, cocaine, ethanol and opiates, unless it is a prescribed medication containing any of these ingredients, the investigator finds it acceptable, and after agreement from the Sponsor medical monitor. 14. Currently smokes more than 5 cigarettes or equivalent per day, and if eligible for the study, would not be able to abstain from smoking from midnight prior to dosing until the end of the study period.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.