Study to Determine Presence of Prediabetes in Subjects with Cardiovascular Disease

This study is being conducted to determine if there is sufficient presence of
prediabetes at investigative sites in subjects with cardiovascular (CV) disease
to warrant a future clinical study in this population.

This study will assess the presence of prediabetes (defined as glycated
hemoglobin [HbA1c] greater or equal to 5.7% and greater or equal to 6.4%, or
fasting plasma glucose [FPG] greater or equal to 100 mg/dL [5.6 mmol/L] and
greater or equal to 125 mg/dL [6.9 mmol/L]) in subjects who have documented
symptomatic atherosclerotic CV disease and are therefore at increased risk for
CV events, with the objectives to
* support the assessment of the feasibility of conducting a clinical study in
this population, and
* identify subjects with CV disease and prediabetes who might have interest in
participating in a future clinical study.

This is a multicenter, exploratory study. No study drug will be administered.
Up to 800 investigative sites will enroll subjects into this study. The initial
duration of the enrollment period for an investigative site will be 2 months.
Extensions to the enrollment period at individual sites may be granted upon
request with the approval from the sponsor. The study is considered completed
after the last subject enrolled completes all study procedures.
To identify potential subjects for this study, chart reviews or a medical
record search will be performed. Subjects with symptomatic atherosclerotic CV
disease, without a history of diabetes, and meeting the inclusion/exclusion
criteria will be contacted as follows:
Group A: Subjects with HbA1c or FPG in the prediabetes range(s) within the
previous 3 months documented in the medical record (excluding HbA1c or FPG
values within 1 month after an acute CV event) will be contacted for their
interest in participating in a future potential clinical study.
Group B: Subjects without HbA1c or FPG in the prediabetes range within the
previous 3 months will be contacted. If they are interested in participating in
a future potential clinical study, they will be invited for a site visit to
determine whether their current HbA1c and/or FPG parameters indicate the
presence of prediabetes. Subjects in Group B will have only one study visit, at
which an informed consent will be signed and blood samples will be collected to
assess HbA1c and FPG.

All subjects meeting the inclusion and exclusion criteria in Group A will be
contacted and asked if they are interested in participating in a future
potential clinical study. If they have interest or may be interested, CV
diagnoses and disease characteristics and HbA1c and/or FPG values will be
recorded, as will their interest in participating in a future potential
clinical study. No study procedures will be performed for Group A subjects.
All subjects meeting the inclusion and exclusion criteria in Group B will be
contacted and asked if they are interested in participating in a future
potential clinical study. If they have interest or may be interested, Group B
subjects will be invited to come to the site for a study visit. At the Group B
study visit, informed consent must be signed before any study procedures are
performed. Each subject will have only 1 study visit, at which blood samples
will be collected to assess HbA1c and FPG. A sample for FPG will be collected
only if a subject comes to the study visit fasting (as per procedure approved
by local Independent Ethics Committee or Institutional Review Board [IEC/IRB]).
If the subject has not fasted before the visit, only a sample for HbA1c will be
collected. Cardiovascular diagnoses and disease characteristics and HbA1c
and/or FPG values will be recorded.
Investigators will be responsible for ensuring follow up of any abnormal
laboratory findings according to the standard of care per local guidance.

Adverse events (serious or non-serious) that are related to the study procedure
(eg, venipuncture) should be recorded in the source documents (eg, progress
notes) according to Good Clinical Practice (GCP) and retained at the site. As
there is no therapeutic intervention in this study, only adverse events that
are serious and related to the study procedure will be reported to the sponsor.