Near-infrared Spectroscopy Guided Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

The aim of this study is to investigate whether near-infrared guided percutaneous coronary intervention in patients with acute myocardial infarction provides improved stent strut coverage at six months compared to conventionally angiography guided percutaneous coronary intervention.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Coronary Artery Disease; Atherosclerosis; Lipid-Rich Atherosclerosis of Coronary Artery; Infarct Ischemia
• Intervention / Treatment: Device: Near-infrared spectroscopy (NIRS); Device: Angiography

Detailed Description

Background Myocardial infarction (MI) secondary to atherosclerotic coronary artery disease is mainly due to plaque-rupture with formation of a luminal thrombogenic material. Lesions responsible for MI are more frequently composed of lipid-rich plaques (LRP) in both culprit and in non-culprit lesions compared to lesions in patients with stable angina.

LRP is thought to be main precursor for future coronary events and may also have an impact on complications following percutaneous coronary intervention (PCI). It has been previously indicated that stent thrombosis (ST) and restenosis often occur when stenting a lipid-rich plaque. And if using angiography guidance only during PCI, there is a potential risk of implantation of a stent edge on a lipid pool, which can result in incomplete stent coverage of a lesion. The incidence of restenosis and ST may be related to the lesion characteristics, clinical presentation, antithrombotic treatment and stent design. Other factors may include inflammatory reaction to the polymer coating containing drug that delays vascular healing, insufficient stent strut coverage and incomplete stent apposition (ISA).

Invasive imaging modality can contribute to better understanding of the changes that occur in the vessel wall during stent implantation.

Intravascular ultrasound (IVUS) combined with a new imaging modality called near-infrared spectroscopy (NIRS) can identify LRP and provide a semi-quantitative estimate of amount of LRP present within selected region of interest. The method is excellent to identify ISA and improve stent implantation technique.

Optical coherence tomography (OCT) is a high resolution imaging modality that can analyze healing pattern after stent implantation such as stent strut coverage.

Method The study is designed as a prospective randomized trial conducted at a single center (Odense University Hospital). Patients with MI will be enrolled if they fulfill the criteria. The study is submitted and approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20200010) and Danish Data Agency (Journal nr.: 20/18008).

Eligible patients will be randomly assigned to either NIRS-guided PCI or conventual angiography-guided PCI with implantation of Everolimus-eluting Xience stent, which is CE marked. NIRS will be performed in both groups after predilation and stent implantation. In NIRS-guided group the analyses will be used to identify LRP, and to measure vessel wall diameter in reference segments and lesion length. In angiography-guided group the analyses will not be available for the PCI operator and are for observation purpose only. OCT will be performed in both groups after stent implantation, but will be only available for interpretation in NIRS-guided group. In case of reintervention in NIRS-guided group, a final OCT will be performed.

Patients will be contacted by telephone to evaluate the clinical situation and to reduce the potential risk of dropout. After 6 months OCT will be performed in both groups to evaluate stent strut coverage and vessel healing.

Statistics Assuming data are normally distributed, categorical data will be presented as numbers and frequencies and compared using chi2-test. Continuous data will be presented as mean ± SD and compared using Student t test. SPSS version 26.0 will be used for the statistical analysis.

Sample size calculation An a priori power calculation at patient level with a mean expected proportion of 75% and 95% covered stent struts at six months in the angio-guided and NIRS-guided group, respectively, shows a sample size of 88 patients is required to reach statistical significance. With 44 patients in each treatment group, and a 2-tailed significance level of 0.05, the study has a power of 80%. With an expected drop-out rate of 15% due to non-compliance in relation to invasive procedures and subject to poor image quality, 104 patients are required to be recruited in the trial.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Manijeh Noori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with acute coronary syndrome (ST-elevation myocardial infarction and non-ST elevation myocardial infarction) referred for invasive coronary angiography and percutaneous coronary intervention at Department of Cardiology, Odense University Hospital (Odense, Denmark)

Exclusion Criteria:

• participation in other randomized clinical trials
• life expectancy < 1 year
• allergy to aspirin, clopidogrel, ticagrelor or prasugrel
• eGFR < 30 mL/min
• tortuous and angiographically estimated extremely calcified lesions
• ostial, left main and bifurcation lesions
• lesions in a reference vessel diameter < 2.0 mm
• hemodynamic instability
• Scheduled for coronary artery bypass grafting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NIRS-guided PCI; Near-infrared Spectroscopy guided Percutaneous coronary intervention with implantation of drug-eluting stent	Device: Near-infrared spectroscopy (NIRS); NIRS-guided PCI
Active Comparator: Angiography-guided PCI; Angiography-guided percutaneous coronary intervention with implantation of a drug-eluting stent	Device: Angiography; Angiography guided PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of stent strut coverage	Proportion of stent strut coverage at 6 months follow up estimated by OCT	6 months after index percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Uncovered stent struts	6 months after index percutaneous coronary intervention
Persistent stent malapposition	6 months after index percutaneous coronary intervention
Maximal neointimal growth	6 months after index percutaneous coronary intervention

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Chair: Lisette Okkels Jensen, MD PhD Prof, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): March 2, 2023

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: optical coherence tomography; drug-eluting stent; intravascular ultrasound; near-infrared spectrocopy
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Vascular Diseases; Ischemia; Atherosclerosis
• Other Study ID Numbers: s-20200010

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: No