跳至主要内容
临床试验/NCT05916976
NCT05916976尚未招募不适用

MRI in Repaired Tetralogy of Fallot: Risc Score Derived From Multiparametric Magnetic Resonance-Imaging and Clinical Data to Sharpen the Indication for Change of Individualized Treatment

University Medical Center Goettingen2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
2
主要终点
Modified therapy cardiovascular

研究概览

简要总结

Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. A new score will be used to summarize the multitude of MRI-based parameters into a single number. Individual modificators are assigned to the components of the score. The value of each modificatory will be determined as a result of this feasibility trial. This new compound score is designed to anticipate any deterioration of cardiac function, arrhythmias or sudden cardiac death. This feasibility study is the first step to establish this score and find initial values for the modifies that are assigned to the more than 40 biomarkers from MRI, clinical examinations and serum parameters that are included in this new score.

详细描述

Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. Though a large number of diverse MRI-derived parameter have been shown to correlate with the incidence of major adverse cardiac events in patients with rTOF, there is not a single MRI-derived parameter that reliably predicts the incidence of heart failure, malignant arrhythmias or sudden cardiac death - the most common major adverse cardiac events in this group (rTOF-MACE). This feasibility trial is set to evaluate the feasibility of a weighted compound risk score based on about 40 parameters derived from MRI and augmented by clinical as well as serum-based biomarkers. This trial will recruit 70 consecutive patients with rTOF and correlate the new compound score with the clinical course over 2 years and the incidence of any change in therapy due to cardiac reasons. At the end of the trial each of the contributing parameters of the compound score will have been assigned a modifier based on its statistical relevance for the prediction of patient-specific rTOF-MACE or any change in cardiac related therapy. Based on this feasibility trial we aim to use the weighted compound score in a large multicenter trial to proof its applicability and relevance to short, medium and longterm prognosis of this special patient group.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

盲法说明

MRI data are made available for clinical decision. Score will not be made available to treatment decision team. Nor is the study team involved in the clinical decision process until completion of follow-up data acquisition

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • rTOF; age above 16; eligible for MRI-exam

排除标准

  • any contraindications to MRI; unstable patient; unresponsive patient

结局指标

主要结局

Modified therapy cardiovascular

时间窗: 24 months

Any change in therapy related to cardiovascular function

次要结局

  • hospitalization(24 months)
  • cardiac intervention(24 months)

研究者

发起方
University Medical Center Goettingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joachim Lotz

Professor of Radiology; Director Institute of Diagnostic and Interventional Radiology

University Medical Center Goettingen

研究点 (2)

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