LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries:

Stopped early

Conditions studied: Coronary Artery Disease, Atherosclerosis

In brief

The goal of this study is to correlate both plaque and % lipid core content assessed by NIRS-IVUS (Imaging technique) to plaque burden and % lipid core content in coronary computerized tomographic angiography (CCTA) completed at 1 week in non-culprit coronary arteries.

Key facts

Study ID

NCT02953613

Run by

Corewell Health East

People needed

7

Starts

2016-04-28

Expected to finish

2017-11-20

Last updated by the study team

2021-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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