Clinical trial NCT06980194: A Head-to-Head Comparison of A New Perfusion Tracer, 99mTc-4BOH vs. 13N-NH3 to Evaluate Diagnostic Efficacy of Ischemic Heart Disease
Official title: A Prospective, Single-Center, Head-to-Head Clinical Trial Comparing 99mTc-4BOH SPECT Myocardial Perfusion Imaging With 13N-Ammonia PET Imaging for the Diagnosis of Myocardial Ischemia, Using Invasive Coronary Angiography and Fractional Flow Reserve as the Reference Standard
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: myocardial blood flow quantification
novel SPECT tracer
myocardial perfusion imaging
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of 99mTc-4BOH SPECT myocardial perfusion imaging (MPI) compared to 13N-ammonia PET MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA).

Detailed description: The goal of this trial is to evaluate whether SPECT myocardial perfusion using the novel tracer 99mTc-4BOH is non-inferior to 13N-ammonia PET in diagnosing myocardial ischemia in patients with fractional flow reserve (FFR) as the diagnostic gold standard. In this study, 13N-ammonia PET imaging will be used as the positive control. Patients with diagnosed CAD who are scheduled for myocardial perfusion imaging will be assigned to undergo head-to-head SPECT imaging with 99mTc-4BOH and PET imaging with 13N-ammonia, with no more than 7 days between scans. All participants will subsequently undergo coronary angiography with FFR measurement within 30 days of imaging. The diagnostic performance of 99mTc-4BOH will be compared to that of 13N-ammonia, using FFR as the reference standard.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years. Presence of angina symptoms, such as chest tightness or chest pain. Coronary CT angiography (CTA) indicating ≥50% stenosis in at least one coronary artery.

Able and willing to provide written informed consent.

Exclusion Criteria:

* Underwent coronary revascularization (PCI or CABG) within the past 6 months. Presence of non-ischemic heart disease or left ventricular ejection fraction (LVEF) \<35%.

Contraindications to adenosine stress (e.g., bronchial asthma, second-degree or higher atrioventricular block, severe hypotension).

Pregnancy or lactation. Unable or unwilling to sign the informed consent form.

Primary outcomes:
measure: Diagnostic accuracy of 99mTc-4BOH SPECT imaging for detecting myocardial ischemia, using FFR as the reference standard
timeFrame: Within 30 days after both imaging procedures
Secondary outcomes:
measure: Non-inferiority of 99mTc-4BOH SPECT vs. 13N-ammonia PET in detecting myocardial ischemia
timeFrame: Within 30 days after imaging and FFR
Other outcomes:
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