Actively Recruiting
Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)
Led by Sinotau Pharmaceutical Group · Updated on 2026-03-03
395
Participants Needed
5
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and fractional flow reserve (FFR) as reference standards in patients with suspected or known coronary artery disease.
CONDITIONS
Official 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
- Suspected patients must have at least one risk factor: hypertension, high cholesterol, diabetes, obesity (BMI 68), history of alcohol abuse, smoking history, family history of coronary heart disease, postmenopausal status, or age 60 or older
- Ability to communicate with investigators, understand and follow study requirements, and provide informed consent
You will not qualify if you...
- Severe cardiovascular diseases including unstable angina (CCS Grade III/IV), uncontrolled hypertension (systolic 65 180 mmHg or diastolic 65 110 mmHg despite treatment), low blood pressure (resting systolic <90 mmHg), recent heart attack, severe heart rhythm problems, heart failure (NYHA Class III/IV), cardiomyopathy, pericarditis, valvular heart disease, aortic dissection, recent coronary artery surgery or interventions within 3 months
- Severe acute or chronic lung diseases such as COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, or pneumonia
- Severe or unstable central nervous system disorders including unstable cerebrovascular diseases, active epilepsy, infections, or diseases with mental or motor impairments
- Severe bleeding or clotting disorders
- Severe liver diseases such as viral hepatitis, autoimmune hepatitis, cirrhosis, or liver cancer
- Severe kidney diseases including glomerulonephritis, renal insufficiency, nephrotic syndrome, membranous nephropathy, hydronephrosis, or renal cystopathy
- Fever or active infections
- Known allergies to alcohol, adenosine, or iodine contrast agents
- Significant occupational exposure to ionizing radiation within past 10 years
- Male or females of childbearing age not using effective contraception during and 6 months after study
- Pregnancy or breastfeeding
- Claustrophobia, bipolar disorder, mental disorders, or poor compliance
- Participation in other investigational drug trials within 30 days 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
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
CONTACT
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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