临床试验/NCT07833774

NCT07833774尚未招募不适用

High-resolution AI-Driven Whole-Heart Perfusion MRI

IRCCS San Raffaele0 个研究点目标入组 300 人开始时间: 2026年9月1日最近更新: 2026年9月22日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: IRCCS San Raffaele
入组人数: 300
主要终点: Noninferiority of accelerated advanced MRI sequences compared to standard MRI sequences, assessed using a paired Wilcoxon signed-rank test at a one-sided significance level of 0.025.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will compare the standard MRI protocol with an advanced MRI protocol for the assessment of ischemic heart disease. The goal is to evaluate whether the advanced protocol provides comparable or improved diagnostic performance relative to the standard approach.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Consecutive adults (≥18 y.o.) admitted to the UO for cardiac MRI with or without stress

排除标准

•Refused to consent
•Claustrophobia
•Metal prosthesis potentially affecting image quality

结局指标

主要结局

Noninferiority of accelerated advanced MRI sequences compared to standard MRI sequences, assessed using a paired Wilcoxon signed-rank test at a one-sided significance level of 0.025.

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方

IRCCS San Raffaele

申办方类型

Other

责任方

Principal Investigator

主要研究者

Antonio Esposito

Director of U.O. Advanced Imaging For Personalized Medicine

IRCCS San Raffaele

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