LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries:

NCT02953613 | Terminated DMC FDA Device

• 1 other identifier: 2015-129
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Atherosclerosis

Keywords

Cardiac Catheterization; Cardiac intervention; coronary angiogram; coronary artery disease; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cardiac Catheterization with NIRS/IVUS

Cardiac cathetirization with NIRS/IVUS assessment if with blockage of indeterminate severity (greater or equal to 20% to 70%). One day to one week after invasive catheterization a CCTA will be done to correlate result, then CCTA will be repeated at 24 months

Device: NIRS/IVUS

Interventions

NIRS/IVUS DEVICE

Cardiac catheterization using infraredx

Also known as: Infraredx

Cardiac Catheterization with NIRS/IVUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients presenting to Beaumont Hospital for elective invasive coronary angioplasty and possible percutaneous intervention

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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ivan Hanson, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: November 3, 2016
• Study Start: April 28, 2016
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)