LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries: (LUNAR-CCTA)

August 3, 2021 updated by: Ivan D. Hanson, William Beaumont Hospitals

LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries: Correlations With Non-invasive Coronary Computer Tomographic Angiography. (LUNAR-CCTA Study)

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.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

This is a prospective single center study that will enroll 200 patients undergoing clinically indicated cardiac catheterization for stable ischemic heart disease or unstable chest pain, who are also undergoing NIRS-IVUS direct coronary imaging of a culprit lesion based on routine clinical indications. The NIRS/IVUS catheter uses near-infrared light (red laser light) and intravascular ultrasound (sound waves) to identify fatty plaques in the coronary artery. Standard angiography, near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) are three widely used clinical methods to image narrowing within the coronary arteries at the time of cardiac catheterization.

Independently from this study, patients have agreed to a cardiac catheterization (angiogram - an x-ray picture of the heart) and possible angioplasty procedure and/or stenting as part of clinical care. During the cardiac catheterization if the blockage is bad enough an inflatable balloon attached to the end of a thin tube (called a catheter) is positioned in the narrowed part of the coronary artery. The balloon is then inflated, which opens the artery so that blood can flow more easily. After the balloon angioplasty procedure, a stent may be placed in the coronary artery. A stent is an expandable metal tube that helps to hold the artery open so that blood can continue to flow through the artery.

If the doctor determines that there are other blockages of indeterminate severity (≥20%-≤70% blockage) that require NIRS/IVUS assessment to better assess the severity of the blockage or that angioplasty and/or stenting is necessary the NIRS/IVUS catheter will be used. If severe non-culprit blockages are incidentally identified, they may be treated at the discretion of the operator. After the invasive coronary catheterization patients will follow Beaumonts standard post procedureal treatment guidlines.

Between one day and one week after the invasive catheterization patients will return for a research related non-invasive coronary Cat scan. A coronary Cat scan will be repeated at 24 months (2 years) to assess any of the blockages of indeterminate severity that were identified during your initial invasive cardiac catheterization. Upon arrival for Cat scan a nurse will ask the patient a few questions, insert a small tube in one of the patients arm veins. Blood will be drawn from the small tub and kidney function will be assessed. All Cat scans will be completed under Beaumont Hospital Institutional guidelines for coronary Cat scans. If significant blockages are identified, the patient may be notified to complete additional testing, which may include a stress test or a coronary angiogram. If other non-cardiac incidental findings are noted that require additional clinical or imaging follow up, the patient and the primary care physician will be notified.

A study doctor, nurse, or research coordinator will follow-up with each patient by phone six times over five years while participating in the registry. Phone calls will be performed at the following intervals from the date of the index procedure: 6 months (± 14 days); 12 months (± 30 days); 24 months (± 60 days); 36 months (± 60 days); 48 months (± 60 days); and 60 months (± 60 days) to ask patients how they are doing and to collect any major adverse cardiac events.

The Plan is for an enrollment period of two years.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Cardiac catheterization using infraredx
Other Names:
  • Infraredx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate blockages by NIRS-IVUS with CCTA
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ivan Hanson, MD, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 28, 2016

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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