Actively Recruiting
Evaluation of XTR004 Injection to Detect Blood Flow Restriction in Stable Coronary Artery Disease Patients Using PET Imaging
Led by Sinotau Pharmaceutical Group · Updated on 2026-03-03
395
Participants Needed
5
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive blood flow problems in patients with suspected or known stable coronary artery disease. This study compares XTR004 PET MPI with quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards to see how well it detects restrictive stenosis. The trial is a multicenter, open-label, phase III clinical study sponsored by Sinotau Pharmaceutical Group. Participants will receive XTR004 as the experimental drug and undergo PET MPI scanning. The study also compares XTR004 PET MPI with MIBI SPECT MPI to evaluate differences in diagnostic accuracy, image quality, and certainty. The process includes using coronary artery angiography as a reference standard. Data will be collected over a 60-day assessment period to analyze diagnostic performance and safety. During the study, participants will undergo imaging tests including XTR004 PET MPI, MIBI SPECT MPI, and coronary angiography. Researchers will monitor diagnostic efficacy, image quality, and any treatment-related adverse events. Participants will be observed for up to 60 days to assess outcomes and safety. The study includes adults aged 18 to 80 years with suspected or confirmed stable coronary artery disease, and participation involves signing informed consent and complying with study requirements.
CONDITIONS
Brief Title
Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 80 years, male or female.
- Suspected or confirmed stable coronary heart disease.
- If suspected, must have at least one risk factor such as hypertension, high cholesterol, diabetes, obesity (BMI ≥28), history of alcohol abuse, smoking history, family history of coronary heart disease, postmenopausal status, or age 60 years or older.
- Ability to communicate well, understand and comply with study requirements.
- Voluntary participation with signed informed consent.
You will not qualify if you...
- Severe cardiovascular diseases including unstable angina (CCS Grade III/IV), uncontrolled high blood pressure, low blood pressure, recent heart attack, serious heart rhythm disorders, heart failure (NYHA Class III/IV), cardiomyopathy, pericarditis, valve disease, aortic dissection, recent heart surgery or interventions within 3 months.
- Severe acute or chronic lung diseases such as COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, embolism, pneumonia.
- Severe or unstable central nervous system disorders, including stroke, epilepsy, infections, mental disorders affecting movement.
- Severe bleeding or clotting disorders.
- Severe liver dysfunction including hepatitis, cirrhosis, liver cancer.
- Severe kidney impairment.
- Fever or active infections.
- Allergies to alcohol, adenosine, or iodine contrast agents.
- Significant recent exposure to ionizing radiation.
- Not using effective contraception if of childbearing age during and 6 months after study.
- Pregnancy or breastfeeding.
- Claustrophobia, bipolar disorder, other mental disorders, or poor compliance.
- Participation in other investigational drug trials within 30 days before enrollment or planned during the study.
- Any other conditions deemed unsuitable by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 days
Participants undergo XTR004 PET myocardial perfusion imaging (MPI), MIBI SPECT MPI, and quantitative coronary angiography (QCA) with fractional flow reserve (FFR) to detect restrictive stenosis.
1 to 2 visits depending on imaging procedures
Trial Site Locations
Total: 5 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Actively Recruiting
2
Beijing Tongren Hospital
Beijing, China
Actively Recruiting
3
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
4
The First People's Hospital of Foshan
Foshan, China
Actively Recruiting
5
TEDA International Cardiovascular Hospital
Tianjin, China
Actively Recruiting
Research Team
L
LING YUAN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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