Clinical trial NCT04596527: 18F-FMPP PET MPI in the Detection of Coronary Artery Disease
Official title: Diagnostic Performance of 18F-FMPP PET Myocardial Perfusion Imaging in the Detection of Coronary Artery Disease: A Comparative Study With 13N-Ammonia PET
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Coronary Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 18F-FMPP is a novel PET myocardial perfusion imaging (MPI) tracer which targets to mitochondria complex I (MC-I). Preclinical animal studies have shown that its uptake is highly uniform and long in the heart and rather low in the liver. It may be a promising tracer for myocardial perfusion imaging. In addition, as a myocardial PET tracer, it is capable of quantifying absolute myocardial blood flow. Thus this prospective and open-label study is going to evaluate the diagnosis performance of 18F-FMPP PET MPI in suspected or known CAD patients who will be referred for invasive coronary angiography (ICA).

Detailed description: PET myocardial perfusion imaging (MPI) can provide not only qualitative images, but also absolute quantitation of myocardial blood flow (MBF) in the unit of ml/min/g to facilitate the early diagnosis of coronary disease (CAD). It can be more beneficial for patients with three-vessel disease, microvascular disease or obesity. At present, the diagnostic capability of 13N-ammonia PET MPI has been well studied, but its clinical usability is largely limited by short half-life. 18F-labeled MPI tracer (18F-FMPP) is a new type of PET tracer for MPI. Preclinical studies showed that 18F-FMPP has important characteristics such as high myocardial retention and low background uptake of adjacent organs, which may be a more ideal drug for PET MPI toward routine clinical utilization. Our study will assess the safety profile, image quality and diagnostic performance of 18F-FMPP PET in detection of CAD by using invasive coronary angiography as the reference standard. In addition, the investigators will further compare the diagnostic performance of 18F-FMPP PET MPI with that of 13N-ammonia PET MPI.

Eligibility criteria: Inclusion Criteria:

* The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
* At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD.
* The subject at least has one or multiple risk factors for coronary heart disease, including hypertension, hyperlipidemia, hyperglycemia, smoking, family history, obesity, post-menopause.
* The subject presents typical symptoms for CAD such as dyspnea, chest tightness and chest pain.
* The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal.
* The subject is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

* Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating.
* Patients incapable of undergoing pharmacological cardiac stress testing.
* Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
* Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF \<50%).
* Patients whose images quality can not meet the requirements.
* Patients who are not suitable to participate in the trial according to researchers.

Primary outcomes:
measure: The evaluation of diagnostic performance of 18F-FMPP PET MPI in the detection of CAD
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Diagnostic rate of 18F-FMPP MPI in CAD patients
timeFrame: through study completion, an average of 2 years
measure: Number of Participants with Adverse events
timeFrame: through study completion, an average of 2 years
measure: good quality rate of images
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Dongcheng
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Huo, PhD
role: PRINCIPAL_INVESTIGATOR
References: