Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written and signed informed consent
Indication for coronary angiography
Abdominal obesity defined by waist circumference \> 88 cm in women or \> 102 cm in men
At least one of the two following conditions: \*a) Metabolic syndrome as defined by the presence of at least two of the following additional risk factors: 1. Triglyceride level \>= 150 mg/dL (1.69 mmol/L); 2. HDL cholesterol \< 40 mg/dL (1.03 mmol/L) \[men\] or 50 mg/dL (1.28 mmol/L) \[women\]; 3. Fasting glucose \>= 110 mg/dL (6.1 mmol/L); 4. High blood pressure (\>= 140 mmHg systolic and/or \>= 90 mmHg diastolic) at Screening visit, or current treatment by anti-hypertensive medication; \*b) Currently smoking (\> 10 cigarettes /day) and willing to stop
Angiographic evidence of coronary heart disease as defined by at least 1 lesion in a native coronary artery that has \>= 20% reduction in lumen diameter by angiographic visual estimation
Presence of at least one coronary artery complying with the definition of "target vessel" for IVUS assessment
Acceptation of the Baseline IVUS tape by the IVUS Core Laboratory
You may not be if
Age \< 18 years
Pregnant or breast-feeding women
History of very low-calorie diet or surgical procedures for weight loss (eg, stomach stapling, bypass) within 6 months prior to screening visit
Obesity of known endocrine origin
Uncontrolled diabetes with HBA1c \>10%
Presence of any severe medical or psychological condition, that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
Severe congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)
Clinically significant heart disease which in the opinion of the Investigator is likely to require coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), cardiac transplantation, surgical repair and/or replacement during the course of the study
Angioplasty of a non-qualifying artery which is considered at high risk of acute complication or restenosis, during baseline catheterization
\>50% reduction in lumen diameter of the left main coronary artery by visual angiographic estimation
Clareo Health | STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
