PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
Recruiting
Phase 2
Interventional Study
Ischemic Cardiomyopathy
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 40 (estimated)
- Sponsor
- Sinotau Pharmaceutical Group · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 suit…
Contacts