NCT06641843

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
103mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Sep 2024Sep 2034

Study Start

First participant enrolled

September 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2034

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2034

Last Updated

October 15, 2024

Status Verified

September 1, 2024

Enrollment Period

9.3 years

First QC Date

October 8, 2024

Last Update Submit

October 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 years after the onset

Study Arms (1)

patients diagnosed with cardiovascular disease

Patients diagnosed with cardiovascular disease, including Kawasaki disease, anomalous origin of coronary artery, postoperative congenital heart diseases

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients diagnosed with cardiovascular disease, including Kawasaki disease, anomalous origin of coronary artery, postoperative congenital heart disease.

You may not qualify if:

  • Mental abnormalities or poor compliance ; heart, kidney and other important organs were seriously incomplete.
  • MRI examination contraindications ; gadolinium contrast agent contraindications ; claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Second University Hospital, Sichuan University.

Chengdu, Sichuan, China

Location

Related Publications (8)

  • 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.

    PMID: 33248966BACKGROUND
  • Erbel 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.

    PMID: 26965729BACKGROUND
  • Shaw 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.

    PMID: 30041981BACKGROUND
  • Park 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.

    PMID: 30904924BACKGROUND
  • Gulati 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.

    PMID: 34709928BACKGROUND
  • Ferrari 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.

    PMID: 32154890BACKGROUND
  • Aetesam-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.

    PMID: 34187187BACKGROUND
  • Patel 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.

    PMID: 34649703BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The whole boold including blood cell and plasma will be collected for laboratory test.

MeSH Terms

Conditions

Mucocutaneous Lymph Node SyndromeCardiovascular Diseases

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

January 1, 2034

Study Completion (Estimated)

September 30, 2034

Last Updated

October 15, 2024

Record last verified: 2024-09

Locations