Status:
TERMINATED
Comparative Imaging of XTR004 PET and MIBI SPECT in Borderline Coronary Stenosis
Lead Sponsor:
Sinotau Pharmaceutical Group
Conditions:
Myocardial Perfusion Imaging
Diagnostic Certainty
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Compare the diagnostic certainty of MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI.
Detailed Description
This trial is a single-arm, single-center, open-label, self-controlled study. Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80%...
Eligibility Criteria
Inclusion
- Male or female participants aged 18 years or older. 2.Suspected or known stable coronary artery disease with related symptoms and stable condition, and having at least one coronary artery disease risk factor, including: hypertension, hyperlipidemia, diabetes, obesity, alcohol abuse, smoking, family history of coronary artery disease, postmenopausal status in women, or advanced age.
- Underwent coronary CTA within the past 6 months showing 30%-90% stenosis, or indicating mild to moderate-to-severe stenosis.
- Able to communicate effectively with the investigators, understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent.
Exclusion
- 1\. Patients with a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- Patients with a prior diagnosis of myocardial infarction, congenital heart disease, cardiomyopathy, myocarditis, or other cardiac diseases.
- Patients known to have severe allergic reactions to alcohol. 4.Patients known to have an allergy or other contraindications to adenosine. 5.Patients known to be allergic to iodinated contrast agents. 6.Individuals with significant occupational exposure to ionizing radiation within the past 10 years (e.g., exceeding 50 mSv/year), or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes.
- Men and women of childbearing potential who do not plan to use effective contraception during the study and for 6 months after study completion (effective methods include sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy/tubal ligation).
- Pregnant or lactating women. 9.Patients with claustrophobia, bipolar disorder, other psychiatric disorders, or poor compliance.
- Patients who participated in another investigational drug clinical study within 30 days prior to enrollment or plan to do so during follow-up.
- Any other condition that, in the opinion of the investigators, makes the patient unsuitable for participation.
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT07187895
Start Date
December 19 2024
End Date
March 5 2025
Last Update
September 23 2025
Active Locations (1)
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1
Fuwai Hospital
Beijing, Beijing Municipality, China, 100176