PET imaging with XTR003 and 18F-FDG to find recoverable heart muscle in ischemic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open‑label Phase IIb study enrolling 40–60 patients with ischemic cardiomyopathy and reduced LVEF who are suitable for complete revascularization. Participants are randomized 1:1 to a fasting XTR003 plus 18F‑FDG PET protocol or a glucose‑loaded 18F‑FDG PET protocol, with resting myocardial perfusion imaging combined with metabolic PET in both arms. Segmental perfusion defects, metabolic activity and myocardial viability will be analyzed by standard nuclear cardiology methods, and regional and global LV function will be measured by cardiac MRI and echocardiography before and after revascularization within six months. A repeat resting MPI will be performed to document any improvement in perfusion after revascularization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 to 85 years, regardless of gender.
2. Diagnosed with ischemic cardiomyopathy (ICM).
3. significant coronary artery disease (CAD).
4. Left ventricular systolic dysfunction, with LVEF ranging from \>20% to ≤40%
5. Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization.
6. 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:

1. Decompensated heart failure within 48 hours prior to enrollment.
2. Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
3. Left ventricular aneurysm.
4. Judged by the investigator as unable to complete PET examination.
5. Severe renal insufficiency.
6. Severe hepatic insufficiency.
7. Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.
8. Pregnant or lactating women.
9. Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.
10. Subjects with mental disorders or poor compliance.
11. 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.
12. Other circumstances deemed by the investigator as unsuitable for trial participation.

Where it's running

• Beijing Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, China Not yet recruiting
• TEDA International Cardiovascular Hospital
  Tianjin, China Not yet recruiting

Study contacts

• Study coordinator: Tao Liu
• Email: tao.liu1@sinotau.com
• Phone: +86-18101131863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.