Clinical trial NCT02953613: LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries:
Official title: LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries: Correlations With Non-invasive Coronary Computer Tomographic Angiography. (LUNAR-CCTA Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: Cardiac Catheterization
Cardiac intervention
coronary angiogram
coronary artery disease
atherosclerosis
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting to Beaumont Hospital for elective invasive coronary angioplasty and possible percutaneous intervention

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To correlate blockages by NIRS-IVUS with CCTA
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Ivan Hanson, MD
role: PRINCIPAL_INVESTIGATOR
References: