18F-FMPP PET MPI in the Detection of Coronary Artery Disease

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

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.