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New treatment option for Coronary Artery Disease(CAD)
Official title Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)
ClinicalTrials.gov ID: NCT07439133
What this study is testing
What is XTR004?
XTR004 is an investigational medicine, being studied as a potential treatment for coronary artery disease(cad).
Also referred to as Drug: 99mTechnicium Sestamibi, Procedure: Coronary angiography.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Participants aged 18 to 80 years, male or female.
- Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of...
- Participants can communicate well with investigators, understand and comply with clinical trial requirements, voluntarily participate in the study...
You likely can't join if
- Participants with severe cardiovascular diseases, including but not limited to unstable angina (Canadian Cardiac Society (CCS) Grade III/IV angina...
- Participants with severe acute or chronic pulmonary diseases (including but not limited to COPD, asthma, bronchiectasis, emphysema, pulmonary...
- Participants with severe or unstable central nervous system disorders (including but not limited to unstable cerebrovascular diseases, active...
- Participants with severe bleeding disorders or coagulation dysfunction (including but not limited to purpura, hemophilia, vitamin K deficiency, etc.)...
- Participants with severe liver dysfunction (including but not limited to viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, etc.) who...
- Participants with severe kidney impairment (including but not limited to glomerulonephritis, renal insufficiency, nephrotic syndrome, membranous...
See the full eligibility criteria
- Participants aged 18 to 80 years, male or female.
- Suspected or confirmed patients with stable coronary heart disease. Those suspected of having stable coronary heart disease must meet at least one of the following risk factors: hypertension, hyperlipidemia, diabetes...
- Participants can communicate well with investigators, understand and comply with clinical trial requirements, voluntarily participate in the study, and sign an informed consent form.
- Participants with severe cardiovascular diseases, including but not limited to unstable angina (Canadian Cardiac Society (CCS) Grade III/IV angina pectoris), uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg...
- Participants with severe acute or chronic pulmonary diseases (including but not limited to COPD, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc.) who are determined unsuitable...
- Participants with severe or unstable central nervous system disorders (including but not limited to unstable cerebrovascular diseases, active epilepsy, CNS infections, CNS diseases accompanied by mental disorders or...
- Participants with severe bleeding disorders or coagulation dysfunction (including but not limited to purpura, hemophilia, vitamin K deficiency, etc.) who are determined unsuitable for participation by the investigator;
- Participants with severe liver dysfunction (including but not limited to viral hepatitis, autoimmune hepatitis, cirrhosis, liver cancer, etc.) who are determined unsuitable for participation by the investigator;
- Participants with severe kidney impairment (including but not limited to glomerulonephritis, renal insufficiency, nephrotic syndrome, membranous nephropathy, hydronephrosis, renal cystopathy, etc.) who are determined...
- Participants with fever or active infectious diseases who are determined unsuitable for participation by the investigator;
- Participants with known alcohol allergy who are determined unsuitable for participation by the investigator;
- participants with known adenosine allergy who are determined unsuitable for participation by the investigator;
- Participants with known iodine contrast agent allergy who are determined unsuitable for participation by the investigator;
- Within the past 10 years, significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv/year) or exposure to radioactive substances or ionizing radiation for therapeutic/research purposes;
- Male or women of childbearing age not using effective contraception during study participation and within 6 months post-study (effective contraception refers to sterilization, intrauterine device, condoms, abstinence...
- Female participants in pregnancy or lactation
- Individuals with claustrophobia, bipolar disorder, mental disorders, or poor compliance;
- Participation in other investigational drug trials within 30 days prior to enrollment or planned during study;
- Any other circumstances determined unsuitable by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Foshan, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Foshan, China; Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.