Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial.
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
received:
06
01
2023
revised:
03
04
2023
accepted:
06
04
2023
medline:
14
8
2023
pubmed:
12
4
2023
entrez:
11
4
2023
Statut:
ppublish
Résumé
The clinical and anatomic complexity of patients undergoing percutaneous coronary interventions (PCI) has increased significantly over the past 2 decades. Contrast induced nephropathy (CIN) significantly impacts prognosis after PCI, therefore minimizing the risk of CIN is important in improving clinical outcomes. Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool which may decrease CIN by projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially reducing iodinated contrast volume during PCI. The Dynamic Coronary Roadmap for Contrast Reduction trial (DCR4Contrast) is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial investigating if DCR use reduces the total contrast volume administered during PCI compared to PCI performed without DCR guidance. DCR4Contrast aims to recruit 394 patients undergoing PCI. The primary end point is the total undiluted iodinated contrast volume administered during the PCI, performed with or without DCR. As of November 14, 2022, 346 subjects have been enrolled. The DCR4Contrast study will investigate the potential contrast-sparing effect of the DCR navigation support tool in patients undergoing PCI. By reducing iodinated contrast administration, DCR has the potential to contribute to reduced risk of CIN and thus increase PCI safety. https://clinicaltrials.gov/ct2/show/NCT04085614.
Sections du résumé
BACKGROUND
The clinical and anatomic complexity of patients undergoing percutaneous coronary interventions (PCI) has increased significantly over the past 2 decades. Contrast induced nephropathy (CIN) significantly impacts prognosis after PCI, therefore minimizing the risk of CIN is important in improving clinical outcomes. Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool which may decrease CIN by projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially reducing iodinated contrast volume during PCI.
STUDY DESIGN AND OBJECTIVES
The Dynamic Coronary Roadmap for Contrast Reduction trial (DCR4Contrast) is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial investigating if DCR use reduces the total contrast volume administered during PCI compared to PCI performed without DCR guidance. DCR4Contrast aims to recruit 394 patients undergoing PCI. The primary end point is the total undiluted iodinated contrast volume administered during the PCI, performed with or without DCR. As of November 14, 2022, 346 subjects have been enrolled.
CONCLUSIONS
The DCR4Contrast study will investigate the potential contrast-sparing effect of the DCR navigation support tool in patients undergoing PCI. By reducing iodinated contrast administration, DCR has the potential to contribute to reduced risk of CIN and thus increase PCI safety.
CLINICAL TRIAL REGISTRATION URL
https://clinicaltrials.gov/ct2/show/NCT04085614.
Identifiants
pubmed: 37040861
pii: S0002-8703(23)00093-5
doi: 10.1016/j.ahj.2023.04.004
pii:
doi:
Substances chimiques
Contrast Media
0
Banques de données
ClinicalTrials.gov
['NCT04085614']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
151-158Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest Breda Hennessey: Speaker at educational events for Philips. John Messenger: Institutional Grant Support, Philips Medical Systems. Ajay Kirtane: Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. Personal: Consulting from IMDS; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Manish Parikh: Advisory Board Medtronic, Boston Scientific and Abbott Vascular. Haim Danenberg: Proctor for Medtronic and Edwards Lifesciences, Institutional grant from Abbott Vascular. Frédéric De Vroey: Speaker educational events Abbott Vascular. Alejandro Curcio: None. Peter Eshuis: Employee of Philips Medical Systems, Best, The Netherlands. Javier Escaned: Advisory board member and speaker at educational events for Philips