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NCT Number: NCT07443696

PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy

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.

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Decompensated heart failure within 48 hours prior to enrollment.
  • Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
  • Left ventricular aneurysm.
  • Judged by the investigator as unable to complete PET examination.
  • Severe renal insufficiency.
  • Severe hepatic insufficiency.
  • Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.
  • Pregnant or lactating women.
  • Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.
  • Subjects with mental disorders or poor compliance.
  • 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.
  • Other circumstances deemed by the investigator as unsuitable for trial participation.

Treatment and study plan

Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging

Drug

Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging

Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

Drug

Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging

Primary outcomes

  1. the sensitivity and specificity of the experimental group and control group

    Time frame: 6 months

    Using the recoverable left-ventricular wall motion abnormality at 6 months post full revascularization as the reference standard to study the sensitivity and specificity of myocardial viability for predicting functional recovery in the experimental group and control group.

Secondary outcomes

  1. Myocardial perfusion-metabolism imaging parameters (segmental level)

    Time frame: 6 months

    include the following three items:

    • summed rest score
    • summed FDG score
    • summed rest score minus summed FDG score
  2. Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

    Time frame: 6 months

    Left ventricular ejection fraction (LVEF, %)

  3. Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

    Time frame: 6 months

    Left ventricular end-diastolic diameter (LVEDD)

  4. Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

    Time frame: 6 months

    Left ventricular end-systolic diameter (LVESD)

  5. Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

    Time frame: 6 months

    Left ventricular end-diastolic volume (LVEDV, mL)

  6. Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization

    Time frame: 6 months

    Left ventricular end-systolic volume (LVESV, mL)

  7. Changes in New York Heart Association Functional Classification (NYHA)

    Time frame: 6 months

  8. Duration Required for PET Myocardial Metabolic Imaging in the Two Groups (min)

    Time frame: day 1

  9. PET Myocardial Metabolic Imaging Quality

    Time frame: day 1

  10. Resting MPI of perfusion abnormality

    Time frame: 6 months

  11. Major adverse cardiac events (MACE)

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sinotau Pharmaceutical Group

Industry

Registry information

Official study 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

Acronym: STB-XTR-003

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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