NCT04460482

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

July 2, 2020

Last Update Submit

June 6, 2025

Conditions

Myocardial InfarctionCoronary Artery DiseaseMyocardial IschemiaAtherosclerosisLipid-Rich Atherosclerosis of Coronary ArteryVascular DiseasesInfarct Ischemia

Keywords

drug-eluting stentnear-infrared spectrocopyintravascular ultrasoundoptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

NIRS-guided PCI

ACTIVE COMPARATOR

Near-infrared Spectroscopy guided Percutaneous coronary intervention with implantation of drug-eluting stent

Device: Near-infrared spectroscopy (NIRS)

Angiography-guided PCI

ACTIVE COMPARATOR

Angiography-guided percutaneous coronary intervention with implantation of a drug-eluting stent

Device: Angiography

Interventions

Near-infrared spectroscopy (NIRS)DEVICE

NIRS-guided PCI

NIRS-guided PCI
AngiographyDEVICE

Angiography guided PCI

Angiography-guided PCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manijeh Noori

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery DiseaseMyocardial IschemiaAtherosclerosisVascular Diseases

Interventions

Spectroscopy, Near-InfraredAngiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesRadiographyDiagnostic Techniques, Cardiovascular

Study Officials

  • Lisette Okkels Jensen, MD PhD Prof

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Offline data analyzis are being performed without knowing which intervention group the patients are from
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible patients randomized to NIRS-guided or standard angiographic-guided intervention with DES
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD-student

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 7, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

March 2, 2023

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)