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正在招募不适用编号 NCT06814587

Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy

报名条件（概要）

  • 年龄：20 Years – 80 Years
  • 性别：不限
  • 健康志愿者：接受

完整入排标准请以官方页面为准。

开展国家/地区

United States

药品与企业信息

Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI)诊断检测

其他名称：HP 13C-MRI, Hyperpolarized Carbon-13 Pyruvate MRI

HP-13C MRI is a metabolic imaging technique that enables real-time assessment of myocardial substrate utilization by tracking the conversion of hyperpolarized \[1-13C\] pyruvate to metabolic intermediates such as bicarbonate and lactate. This imaging modality provides insights into oxidative metabolism and mitochondrial function, facilitating the identification of metabolically active and ischemic myocardial regions in patients with ischemic cardiomyopathy.

[¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)诊断检测

其他名称：FDG PET, 18F-FDG PET, Fluorodeoxyglucose PET

FDG-PET is a molecular imaging technique used to assess myocardial viability by quantifying glucose uptake in cardiac tissue. This method differentiates viable myocardium, which retains metabolic activity, from non-viable scar tissue. FDG-PET is widely used in ischemic cardiomyopathy for viability assessment to guide revascularization decisions.

SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)诊断检测

This procedure involves a Rest and a Stress SPECT Myocardial Perfusion Imaging Study. It uses myocardial perfusion imaging (MPI) with a radioactive tracer to compare pictures of the heart at rest and during stress, induced either by treadmill exercise or the medication Regadenoson.

研发企业

University of Texas Southwestern Medical Center研究机构/其他

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • American Heart Association研究机构/其他

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

This prospective, non-blinded, single-center, translational research study aims to validate a multimodal advanced imaging exam for cardiac viability. The protocol utilizes three distinct imaging modalities: Single Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT MPI), 18F-fluorodeoxyglucose positron emission tomography (FDG-PET), and Hyperpolarized Carbon-13 (HP-13C) Pyruvate Magnetic Resonance Imaging (MRI). Under this protocol, the SPECT MPI and FDG-PET exams will be used in combination to comprehensively assess myocardial viability. Concurrently, the HP-13C Pyruvate MRI will be utilized to provide additional insights into myocardial metabolism. The study will evaluate healthy volunteers to establish baseline parameters and patients with ischemic cardiomyopathy (ICM) before and after surgical revascularization.

适应症

Coronary Artery DiseaseCoronary Artery Bypass Graft (CABG)

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人（申办方／研究总部）

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
ClinicalTrials.gov Identifier: NCT06814587
Sponsor: University of Texas Southwestern Medical Center
Investigational product: Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI), [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：Hyperpolarized 13C Pyruvate-MRI and FDG-PET in a Single Exam for the Prognosis of Ischemic Cardiomyopathy
试验编号：NCT06814587
申办方：University of Texas Southwestern Medical Center
研究药物：Hyperpolarized 13C Pyruvate Magnetic Resonance Imaging (HP-13C MRI)、[¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)、SPECT MPI (Single Photon Emission Computed Tomography Myocardial Perfusion Imaging)

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 sarah.mcneil@utsouthwestern.edu

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面