Identifying Vulnerable Plaques in Blood Vessels of the Heart Using a New Imaging Technique
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Natural History of Vulnerable Coronary Plaques|
- Determine prevalence of vulnerable plaques [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Safety of OFDI imaging [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: OFDI imaging
OFDI catheter will be advanced to the distal coronary artery and imaging will be conducted.
Device: OFDI system
Imaging of the culprit lesion using the OFDI system.
No Intervention: IVUS before or after OFDI Imaging
Randomization to determine whether Intravenous Ultrasound will be conducted before or after OFDI imaging.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540761
|Contact: Guillermo Tearney, MD, PhDemail@example.com|
|Contact: Mireille Rosenberg, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Guillermo Tearney|
|Contact: Mireille Rosenberg|
|Lahey Clinic||Active, not recruiting|
|Burlington, Massachusetts, United States, 01805|
|United States, New York|
|Columbia Presbyterian Medical Center||Completed|
|New York, New York, United States, 10032|
|Principal Investigator:||Guillermo Tearney, MD, PhD||Massachusetts General Hospital|