LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries:

This is a prospective single center study that will enroll 200 patients undergoing clinically
indicated cardiac catheterization for stable ischemic heart disease or unstable chest pain,
who are also undergoing NIRS-IVUS direct coronary imaging of a culprit lesion based on
routine clinical indications. The NIRS/IVUS catheter uses near-infrared light (red laser
light) and intravascular ultrasound (sound waves) to identify fatty plaques in the coronary
artery. Standard angiography, near-infrared spectroscopy (NIRS) and intravascular ultrasound
(IVUS) are three widely used clinical methods to image narrowing within the coronary arteries
at the time of cardiac catheterization.

Independently from this study, patients have agreed to a cardiac catheterization (angiogram -
an x-ray picture of the heart) and possible angioplasty procedure and/or stenting as part of
clinical care. During the cardiac catheterization if the blockage is bad enough an inflatable
balloon attached to the end of a thin tube (called a catheter) is positioned in the narrowed
part of the coronary artery. The balloon is then inflated, which opens the artery so that
blood can flow more easily. After the balloon angioplasty procedure, a stent may be placed in
the coronary artery. A stent is an expandable metal tube that helps to hold the artery open
so that blood can continue to flow through the artery.

If the doctor determines that there are other blockages of indeterminate severity (≥20%-≤70%
blockage) that require NIRS/IVUS assessment to better assess the severity of the blockage or
that angioplasty and/or stenting is necessary the NIRS/IVUS catheter will be used. If severe
non-culprit blockages are incidentally identified, they may be treated at the discretion of
the operator. After the invasive coronary catheterization patients will follow Beaumonts
standard post procedureal treatment guidlines.

Between one day and one week after the invasive catheterization patients will return for a
research related non-invasive coronary Cat scan. A coronary Cat scan will be repeated at 24
months (2 years) to assess any of the blockages of indeterminate severity that were
identified during your initial invasive cardiac catheterization. Upon arrival for Cat scan a
nurse will ask the patient a few questions, insert a small tube in one of the patients arm
veins. Blood will be drawn from the small tub and kidney function will be assessed. All Cat
scans will be completed under Beaumont Hospital Institutional guidelines for coronary Cat
scans. If significant blockages are identified, the patient may be notified to complete
additional testing, which may include a stress test or a coronary angiogram. If other
non-cardiac incidental findings are noted that require additional clinical or imaging follow
up, the patient and the primary care physician will be notified.

A study doctor, nurse, or research coordinator will follow-up with each patient by phone six
times over five years while participating in the registry. Phone calls will be performed at
the following intervals from the date of the index procedure: 6 months (± 14 days); 12 months
(± 30 days); 24 months (± 60 days); 36 months (± 60 days); 48 months (± 60 days); and 60
months (± 60 days) to ask patients how they are doing and to collect any major adverse
cardiac events.

The Plan is for an enrollment period of two years.

Inclusion Criteria:

- Patients with stable ischemic heart disease or ACS undergoing cardiac catheterization
and possible PCI of a culprit lesion

- The study patient or the study patient's legal representative has been informed of the
nature of the study, agrees to its provisions and has provided written informed
consent approved by the Institutional Review Board.

- The study patient agrees to comply with all required post-procedure follow up.

- Patient age 18-89 years old

Exclusion Criteria:

- STEMI within the prior 24 hours

- Cardiogenic shock or hypotension needing inotropes or hemodynamic support device

- Intra-procedural complication (perforation or a complication that would necessitate
immediate-unplanned revascularization) during index PCI procedure

- History of CABG

- Subject life expectancy less than 2 years at time of index catheterization

- Pregnant or unknown pregnancy status

- Psychological unsuitability or extreme claustrophobia

- Currently participating in another investigational cardiac device study. Note: Trials
requiring extended follow-up for products that were investigational, but have since
become commercially available, are not considered investigational trials

- Inability to tolerate beta blockers

- Atrio-ventricular block (grade II-III), prolonged QT interval or sick sinus syndrome

- Renal insufficiency (creatinine ≥ 1.6 and/or, GFR < 60 ml/min) or renal failure
requiring dialysis