Coronary DiseaseNCT04022395
Stress CMR in Pediatric Patients With Suspected Coronary Artery Disease
A study testing stress cardiac MRI in people with Coronary Disease, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- stress cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2018to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- coronary atresia
- familiar Hypercholesterolemia
- bicuspid aortic valve
- chest pain
- exertional dyspnea of suspected coronary artery nature
- coronary artery fistula
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance Between Stress CMR and Coronary Angiography 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
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- stress cardiac MRI
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress cardiac MRIDiagnostic test
pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia
| Study group | Role | What they receive |
|---|---|---|
| stress cardiac MRI | Experimental | * 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 Receives: Diagnostic Test: stress cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiparameters diagnostic concordance
- Agreement of results between stress cMRI and the current practice constituted by Exercise test, Stress Cardiac Ultrasound and Invasive Angiography
Measured: 24 month
Secondary outcomes (2)
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
Measured: 24 month
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start18 Oct 2018
- Primary completion28 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Stagnaro, Istituto Giannina Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022395
- Sponsor's protocol ID
- 519REG2016
- Status last verified
- Sep 2021
- First submitted
- 15 Mar 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Stress CMR and Coronary Angiography in Pediatric Patients With Suspected Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04022395
- Acronym / sponsor ID
- 519REG2016
- Conditions
- Coronary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stress cardiac MRI | Experimental | Diagnostic Test: stress cardiac MRI* 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Between 8 and 18 years-old patients symptomatic and non, with suspected or previously diagnosed coronary arteries disease
Key exclusion criteria (13 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress cardiac MRIpharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia | Diagnostic test | stress cardiac MRI |
Primary outcome
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
2 secondary outcomes
Efficacy of stress cMRI
Time frame: 24 month
Incidence of Treatment-Emergent Adverse Events
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress cardiac MRI in people with Coronary Disease, run by Istituto Giannina Gaslini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiparameters diagnostic concordance (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.