A Head-to-Head Comparison of A New Perfusion Tracer, 99mTc-4BOH vs. 13N-NH3 to Evaluate Diagnostic Efficacy of Ischemic Heart Disease

N/ANot Yet RecruitingNCT06980194

China National Center for Cardiovascular Diseases300 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Coronary Artery Disease

Interventions

99mTc-4BOH SPECT myocardial perfusion imagingDIAGNOSTIC_TEST

Participants undergo myocardial perfusion imaging using the investigational radiotracer 99mTc-4BOH with SPECT. Imaging is performed according to a standardized protocol. Each participant receives both this SPECT imaging and a PET imaging procedure using 13N-ammonia, in a randomized sequence, within a 7-day interval.

13N-ammonia PET myocardial perfusion imagingDIAGNOSTIC_TEST

Participants undergo myocardial perfusion imaging using 13N-ammonia with PET as the active comparator. This procedure is performed according to standard clinical protocols. Each participant also receives 99mTc-4BOH SPECT imaging in a randomized sequence, with both tests completed within a 7-day window.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Diagnostic accuracy of 99mTc-4BOH SPECT imaging for detecting myocardial ischemia, using FFR as the reference standard

Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of 99mTc-4BOH SPECT myocardial perfusion imaging in detecting myocardial ischemia, compared to fractional flow reserve (FFR ≤0.80) as the diagnostic gold standard.

Time frame: Within 30 days after both imaging procedures

Secondary Outcomes

Non-inferiority of 99mTc-4BOH SPECT vs. 13N-ammonia PET in detecting myocardial ischemia

Assessment of the non-inferiority of 99mTc-4BOH SPECT imaging compared to 13N-ammonia PET imaging in detecting myocardial ischemia, using FFR as the gold standard. Analysis will be based on paired comparison and pre-specified non-inferiority

Time frame: Within 30 days after imaging and FFR

Data from ClinicalTrials.gov

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