Coronary Artery Disease Clinical Trial
— LUNAR-CCTAOfficial title:
LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries: Correlations With Non-invasive Coronary Computer Tomographic Angiography. (LUNAR-CCTA Study)
NCT number | NCT02953613 |
Other study ID # | 2015-129 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | April 28, 2016 |
Est. completion date | November 20, 2017 |
Verified date | August 2021 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | November 20, 2017 |
Est. primary completion date | November 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | William Beaumont Hospital | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
William Beaumont Hospitals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To correlate blockages by NIRS-IVUS with CCTA | To correlate both plaque burden and % lipid core content assessed by NIRS-IVUS to plaque burden and % lipid core content on coronary computerized tomographic angiography (CCTA) completed at 1 week in non-culprit coronary arteries. | 5 years |
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