Comparative Imaging of XTR004 PET and MIBI SPECT in Borderline Coronary Stenosis (NCT07187895) | Clinical Trial Compass
TerminatedPhase 2
Comparative Imaging of XTR004 PET and MIBI SPECT in Borderline Coronary Stenosis
Stopped: The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.
China17 participantsStarted 2024-12-19
Plain-language summary
Compare the diagnostic certainty of MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1.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.
* 3.Underwent coronary CTA within the past 6 months showing 30%-90% stenosis, or indicating mild to moderate-to-severe stenosis.
* 4.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 Criteria:
* 1\. Patients with a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
* 2.Patients with a prior diagnosis of myocardial infarction, congenital heart disease, cardiomyopathy, myocarditis, or other cardiac diseases.
* 3.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.
* 7.Men and women of childbearing potenti…
What they're measuring
1
Percentage of vessel-level diagnostic certainty for XTR004 PET/MIBI SPECT myocardial perfusion imaging.