Kawasaki DiseaseNCT06641843
Magnetic Resonance Myocardial Stress Perfusion in Pediatric Patients with Cardiovascular Disease
An observational study of Kawasaki Disease and Cardiovascular Disease, run by West China Second University Hospital at 1 site in China.
Trial summary
the goal of this observational study is to evaluate myocardial ischemia and myocardial microcirculation dysfunction in children with cardiovascular disease by myocardial stress perfusion imaging. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Kawasaki Disease, Cardiovascular Disease, Anomalous Origin of Coronary Artery
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Sep 2034
- Phase
- Observational
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: From September 2024 to Jaunary 2034, pediatric patients diagnosed with cardiovascular disease were prospectively recruited from West China Second University Hospital, Sichuan University.
Who may be able to join
- Patients diagnosed with cardiovascular disease, including Kawasaki disease, anomalous origin of coronary artery, postoperative congenital heart disease.
Who cannot join
- Mental abnormalities or poor compliance ; heart, kidney and other important organs were seriously incomplete.
- MRI examination contraindications ; gadolinium contrast agent contraindications ; claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Second University Hospital, Sichuan University.
Chengdu, Sichuan
About this study
Official title: Magnetic Resonance Myocardial Stress Perfusion: to Improve the Myocardial Evaluation in Pediatric Patients with Cardiovascular Disease
the goal of this observational study is to evaluate myocardial ischemia and myocardial microcirculation dysfunction in children with cardiovascular disease by myocardial stress perfusion imaging.
During their disease progress, participants will undergo myocardial stress perfusion, laboratory tests when hospitalization and follow-up, and the baseline data will be collected in the admission. all the above examination data will be analysed to identify early subclinical myocardial changes and evaluate the value of magnetic resonance myocardial stress perfusion in predicting prognosis.
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed with cardiovascular disease | Patients diagnosed with cardiovascular disease, including Kawasaki disease, anomalous origin of coronary artery, postoperative congenital heart diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovscualr events
Major adverse cardiovascular events including cardiac death, transient ischemic attack or stroke, myocardial infarction, arrhythmia, heart failure, severe valvular disease, percutaneous coronary intervention, coronary artery bypass graft, and other cardiovascular surgery.
Measured: 10 years after the onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Jan 2034 (estimated)
- Study completion30 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Kawasaki 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Yi Wen, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641843
- Sponsor's protocol ID
- WestChinaSUH2024223
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou W, Lee JCY, Leung ST, Lai A, Lee TF, Chiang JB, Cheng YW, Chan HL, Yiu KH, Goh VK, Pennell DJ, Ng MY. Long-Term Prognosis of Patients With Coronary Microvascular Disease Using Stress Perfusion Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2021 Mar;14(3):602-611. doi: 10.1016/j.jcmg.2020.09.034. Epub 2020 Nov 25.
PubMed 33248966Erbel C, Mukhammadaminova N, Gleissner CA, Osman NF, Hofmann NP, Steuer C, Akhavanpoor M, Wangler S, Celik S, Doesch AO, Voss A, Buss SJ, Schnabel PA, Katus HA, Korosoglou G. Myocardial Perfusion Reserve and Strain-Encoded CMR for Evaluation of Cardiac Allograft Microvasculopathy. JACC Cardiovasc Imaging. 2016 Mar;9(3):255-66. doi: 10.1016/j.jcmg.2015.10.012.
PubMed 26965729Shaw JL, Nelson MD, Wei J, Motwani M, Landes S, Mehta PK, Thomson LEJ, Berman DS, Li D, Bairey Merz CN, Sharif B. Inverse association of MRI-derived native myocardial T1 and perfusion reserve index in women with evidence of ischemia and no obstructive CAD: A pilot study. Int J Cardiol. 2018 Nov 1;270:48-53. doi: 10.1016/j.ijcard.2018.06.086. Epub 2018 Jun 22.
PubMed 30041981Park SM, Wei J, Cook-Wiens G, Nelson MD, Thomson L, Berman D, Handberg E, Petersen J, Anderson D, Pepine CJ, Merz CNB. Left ventricular concentric remodelling and functional impairment in women with ischaemia with no obstructive coronary artery disease and intermediate coronary flow reserve: a report from the WISE-CVD study. Eur Heart J Cardiovasc Imaging. 2019 Aug 1;20(8):875-882. doi: 10.1093/ehjci/jez044.
PubMed 30904924Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, Blankstein R, Boyd J, Bullock-Palmer RP, Conejo T, Diercks DB, Gentile F, Greenwood JP, Hess EP, Hollenberg SM, Jaber WA, Jneid H, Joglar JA, Morrow DA, O'Connor RE, Ross MA, Shaw LJ. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Nov 30;144(22):e368-e454. doi: 10.1161/CIR.0000000000001030. Epub 2021 Oct 28.
PubMed 34709928Ferrari R, Rosano G. 2019 guidelines for the diagnosis and management of chronic coronary syndromes: congratulations and criticism. Eur Heart J Cardiovasc Pharmacother. 2020 Sep 1;6(5):331-332. doi: 10.1093/ehjcvp/pvaa006. No abstract available.
PubMed 32154890Aetesam-Ur-Rahman M, Brown AJ, Jaworski C, Giblett JP, Zhao TX, Braganza DM, Clarke SC, Agrawal BSK, Bennett MR, West NEJ, Hoole SP. Adenosine-Induced Coronary Steal Is Observed in Patients Presenting With ST-Segment-Elevation Myocardial Infarction. J Am Heart Assoc. 2021 Jul 6;10(13):e019899. doi: 10.1161/JAHA.120.019899. Epub 2021 Jun 30.
PubMed 34187187Patel AR, Salerno M, Kwong RY, Singh A, Heydari B, Kramer CM. Stress Cardiac Magnetic Resonance Myocardial Perfusion Imaging: JACC Review Topic of the Week. J Am Coll Cardiol. 2021 Oct 19;78(16):1655-1668. doi: 10.1016/j.jacc.2021.08.022.
PubMed 34649703