68Ga-DOTATATE PET-CTA imaging for the early detection of progressing coronary atherosclerosis

Phase 1

Conditions: Patients with coronary atherosclerosis without significant myocardial ischemia
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2017-004793-34-FR

Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 250

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

-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).