Patients with coronary atherosclerosis without significant myocardial ischemia
Conditions
Interventions
Trade Name: Netspot
Product Name: NetSpot
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a coronary artery calcium score (CACS) measured with a low-dose CT between 100 and 1000 and absence of significant ischemia (= 12 % of the myocardium) on myocardial perfusion scintigraphy. - Age = 18 years - Affiliation to a social security regime - Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: - Previous acute coronary syndrome or coronary revascularisation - LVEF < 40 % - Previous severe adverse reaction to iodinated contrast agent - Irregular heart rhythm (chronic atrial fibrillation, numerous extrasystoles) - Severe asthma - Chronic kidney disease (eGFR < 45 ml/min/1.73 m2) - Waldenstrom disease - Multiple myeloma - Autoimmune / inflammatory disease requiring immunosuppressive treatment. - Active cancer. - Confirmed or suspected pregnancy - Impossibility to stay immobile and maintain the supine position during 30 minutes. - Patient deprived of liberty or under legal protection measure - Participation to an interventional trial involving the use of radiation during the two years of the study. - Participation to an interventional trial with the use of new drugs between the inclusion and one month after injecting 68Ga-DOTATATE (expected time period when SAE might occur in relation to the injection of DOTATATE).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to test the association between the intensity of 68Ga-DOTATATE uptake in coronary plaques quantified with PET at M0 and the absolute progression rate of coronary artery calcium scoring (CACS) measured between the CT acquired at M0 and after 2 years. ;Secondary Objective: 1. to identify a threshold for the intensity of 68Ga-DOTATATE-PET (mean TBR) in coronary plaques quantified with PET at M0 associated with a higher probability of clinical coronary events after a 2-year follow-up, defined by the composite of cardiovascular death, acute coronary syndromes and ischemia-driven coronary revascularization at two years.;Primary end point(s): Maximum TBR will be measured in 2D ROIs drawn around all major epicardial coronary arteries (diameter >2 mm) identified on the coronary CTA and averaged into a mean TBR value per patient. The increase in CACS will be measured as the difference between the CACS measured at M0 and 2 years later. ;Timepoint(s) of evaluation of this end point: Maximum TBR will be measured in 2D ROIs drawn around all major epicardial coronary arteries (diameter >2 mm) identified on the coronary CTA and averaged into a mean TBR value per patient. The increase in CACS will be measured as the difference between the CACS measured at M0 and 2 years later. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to identify a threshold for the intensity of 68Ga-DOTATATE-PET (mean TBR) in coronary plaques quantified with PET at M0 associated with rapid progression of CACS (> 100 HU /year);Timepoint(s) of evaluation of this end point: Maximum TBR will be measured in 2D ROIs drawn around all major epicardial coronary arteries (diameter >2 mm) identified on the coronary CTA and averaged into a mean TBR value per patient. The increase in CACS will be measured as the difference between the CACS measured at M0 and 2 years later. | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed