Under construction – not a live service
Sign in
Taking people in ChinaPhase 2

Heart scans with XTR003 and 18F-FDG to check living heart muscle in ischemic cardiomyopathy

Compares two PET scan methods that check heart muscle health in ischemic cardiomyopathy.

Key facts

Who runs it
Sinotau Pharmaceutical Group
Where
Beijing and Tianjin, ChinaSee the 3 sites
Trial code
Registry title
PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
Status
Recruiting
Phase
Phase 2
People taking part
40 people, planned
Started
18 Dec 2025
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging
  • Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 85 with ischemic cardiomyopathy and significant coronary artery disease, whose heart pumping is weakened and who can have full revascularization.

Age
18 to 85 years
Sex
All sexes can join.
Disease stage
Ischemic cardiomyopathy with significant coronary artery disease; left ventricular ejection fraction (LVEF) above 20% and up to 40%; a surgical team judges that complete revascularization is possible.

Main reasons for not taking part

  • Decompensated heart failure within 48 hours before enrollment
  • Recent ST-segment elevation myocardial infarction (STEMI) less than 4 weeks ago
  • Left ventricular aneurysm
  • Severe kidney or liver insufficiency
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Aged 18 to 85 years, regardless of gender
  • Diagnosed with ischemic cardiomyopathy (ICM)
  • significant coronary artery disease (CAD)
  • Left ventricular systolic dysfunction, with LVEF ranging from >20% to ≤40%
  • Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization
  • Capable of effective communication with the investigators, able to understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent after being fully informed

Who cannot take part

  • Decompensated heart failure within 48 hours prior to enrollment
  • Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants
  • Significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv per year) or exposure to radioactive substances/ionizing radiation for therapeutic or research purposes within the past 10 years
  • Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks
  • Severe renal insufficiency
  • Severe hepatic insufficiency
  • Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation
  • Subjects with mental disorders or poor compliance
  • Left ventricular aneurysm
  • Judged by the investigator as unable to complete PET examination
  • Pregnant or lactating women
  • Other circumstances deemed by the investigator as unsuitable for trial participation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in China

  • Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaContact: Xu Ke YangTaking people
  • Beijing Chaoyang Hospital, Capital Medical UniversityBeijing, ChinaContact: Tao LiuNot yet recruiting
  • TEDA International Cardiovascular HospitalTianjin, ChinaContact: Tao LiuNot yet recruiting

About the trial

What the trial wants to find out

This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. A total of 40-60 patients will be enrolled and randomized into two study groups as: fasting XTR003/18F-FDG group and glucose-loaded group at a 1:1 ratio. Each group will receive resting myocardial perfusion imaging (MPI) combined with metabolic PET imaging to evaluate myocardial metabolic activity and myocardial viability. Segmental perfusion abnormality, metabolic activity and myocardial viability will be analyzed according to the standard approaches in Nuclear Cardiology. Regional and global left ventricular function will be assessed with cardiac MRI and echocardiography prior to and post the completion of full revascularization within 6-month time point. A repeated resting MPI will also be performed to assess the improvement of perfusion abnormality.

Read full original descriptionShow less

All study subjects will undergo 6 months follow-up for major adverse cardiac events (MACE).

The 2 groups in the trial

  • Fasting XTR003/ ¹⁸F-FDG PETTreatment being tested

    Fasting XTR003 and ¹⁸F-FDG PET combined with myocardial metabolic imaging

    Treatment: Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging

  • Glucose-modulated ¹⁸F-FDG PETExisting treatment, for comparison

    Glucose-modulated ¹⁸F-FDG PET Myocardial Metabolic Imaging

    Treatment: Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Open-Label, Parallel-Controlled Phase IIb Clinical Trial of PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection Integrated With 18F-FDG for the Assessment of Myocardial Viability in Patients With Ischemic Cardiomyopathy
Plain-language title
Heart scans with XTR003 and 18F-FDG to check living heart muscle in ischemic cardiomyopathyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07443696, who can take part
Record updated
12 November 2026