Identifying Vulnerable Plaques in Blood Vessels of the Heart Using a New Imaging Technique

Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances
build up along the inner walls of arteries; these deposits are known as plaque. As plaque
builds up, it increases the risk of heart attack. Previous autopsy studies have shown that
vulnerable plaques, a type of atherosclerotic plaque, are commonly found in people who have
had a heart attack. Until recently it has been difficult to identify vulnerable plaques in
people prior to their death. Many people who have coronary artery disease and are at risk of
having a heart attack undergo angioplasty, a procedure that opens a narrowed or blocked blood
vessel. During angioplasty, imaging devices are often used to take pictures of the inside of
blood vessels. The most commonly used imaging device, an intravenous ultrasound (IVUS)
catheter, is threaded through the blood vessels and uses sound waves to take pictures. An
OFDI is a new type of catheter that takes more detailed pictures of blood vessel walls and
plaques. The additional detail provided by OFDI images may improve detection of vulnerable
plaques, which may help physicians identify people who are at high risk of having a heart
attack. This study will use standard IVUS imaging and OFDI to examine vulnerable plaques
within blood vessels of the heart and to evaluate any changes that occur over time in heart
blood vessels and plaque.

This study will enroll people with coronary artery disease who are undergoing angioplasty. At
a baseline study visit, participants will first undergo an angiography procedure, in which
x-ray pictures will be taken of the heart blood vessels. Participants will then be randomly
assigned to undergo either the IVUS procedure followed by the OFDI procedure or vice versa.
Repeat angiographies will occur after each imaging procedure. Next, participants will undergo
angioplasty and a stent will be placed at the area of the blood vessel that is narrowed or
blocked to keep the blood vessel open. Finally, participants will undergo repeat IVUS and
OFDI procedures. For some participants, the study physician may perform the IVUS and OFDI
procedures only after the angioplasty. Every six months and for a period of two years,
participants will complete questionnaires about medication history and heart problems that
may have occurred since the baseline visit.Blood collection will occur if this is done during
office visit.

Inclusion Criteria:

- Undergoing PCTI for coronary artery disease

- Women with childbearing potential must have a negative pregnancy test within the 7
days prior to study entry

Exclusion Criteria:

- Kidney insufficiency (i.e., GFR<50ml/min)

- OR pregnancy

- OR people who have had a ST elevation heart attack will be excluded for at least 72
hours post-heart attack and until cardiac enzymes return to normal. People who have
had a non-ST elevation heart attack will be excluded if they have evidence of ongoing
ischemia, defined as chest pain or new electrocardiogram (ECG) changes in the 12 hours
prior to study entry and/or rising creatine kinase (CK) and CK-MB serum enzymes.

- OR high-risk and complex lesions, including tortuous blood vessels and lesions with
thrombosis

- OR unprotected left main coronary artery disease

- OR enrolled in another investigational clinical trial within the 6 months prior to
study entry

- OR severe peripheral vascular disease

- OR active ischemia

- OR congestive heart failure

- OR prior coronary artery bypass surgery

- OR emergent procedures

- OR inability to return for study follow-up procedures