Not Yet RecruitingNot Applicable

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

300 participantsStarted 2025-08-01

Plain-language 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).

Who can participate

Age range18 Years – 80 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: * 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.

What they're measuring

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

Trial details

NCT IDNCT06980194

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-12-30

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