Document Detail


In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study.
MedLine Citation:
PMID:  19608137     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: To determine whether catheter-based near-infrared spectroscopy (NIRS) signals obtained with a novel catheter-based system from coronaries of patients are similar to those from autopsy specimens and to assess initial safety of NIRS device. BACKGROUND: An intravascular NIRS system for detection of lipid core-containing plaques (LCP) has been validated in human coronary autopsy specimens. The SPECTACL (SPECTroscopic Assessment of Coronary Lipid) trial was a parallel first-in-human multicenter study designed to demonstrate the applicability of the LCP detection algorithm in living patients. METHODS: Intracoronary NIRS was performed in patients undergoing percutaneous coronary intervention. Acquired spectra were blindly compared with autopsy NIRS signals with multivariate statistics. To meet the end point of spectral similarity, at least two-thirds of the scans were required to have >80% of spectra similar to the autopsy spectra. RESULTS: A total of 106 patients were enrolled; there were no serious adverse events attributed to NIRS. Spectroscopic data could not be obtained in 17 (16%) patients due to technical limitations, leaving 89 patients for analysis. Spectra from 30 patients were unblinded to test the calibration of the LCP detection algorithm. Of the remaining 59 blinded cases, after excluding 11 due to inadequate data, spectral similarity was demonstrated in 40 of 48 spectrally adequate scans (83% success rate, 95% confidence interval: 70% to 93%, median spectral similarity/pullback: 96%, interquartile range 10%). The LCP was detected in 58% of 60 spectrally similar scans from both cohorts. CONCLUSIONS: This intravascular NIRS system safely obtained spectral data in patients that were similar to those from autopsy specimens. These results demonstrate the feasibility of invasive detection of coronary LCP with this novel system. (SPECTACL: SPECTroscopic Assessment of Coronary Lipid; NCT00330928).
Authors:
Sergio Waxman; Simon R Dixon; Philippe L'Allier; Jeffrey W Moses; John L Petersen; Donald Cutlip; Jean-Claude Tardif; Richard W Nesto; James E Muller; Michael J Hendricks; Stephen T Sum; Craig M Gardner; James A Goldstein; Gregg W Stone; Mitchell W Krucoff
Related Documents :
2527047 - Outcome in patients with recurrent restenosis after percutaneous transluminal balloon a...
7504867 - Estimation of myocardial damage in kawasaki disease using antimyosin antibody.
10866887 - Severe cardiovascular depression with remifentanil.
10751787 - Clinical features of emergency department patients presenting with symptoms suggestive ...
10933987 - Inter-ictal and post-ictal psychoses in frontal lobe epilepsy: a retrospective comparis...
24894117 - Facial tremor in dystonia.
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't; Validation Studies    
Journal Detail:
Title:  JACC. Cardiovascular imaging     Volume:  2     ISSN:  1876-7591     ISO Abbreviation:  JACC Cardiovasc Imaging     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2009-07-17     Completed Date:  2009-09-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101467978     Medline TA:  JACC Cardiovasc Imaging     Country:  United States    
Other Details:
Languages:  eng     Pagination:  858-68     Citation Subset:  IM    
Affiliation:
Lahey Clinic, Burlington, Massachusetts 01805, USA. Sergio.Waxman@lahey.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00330928
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Aged
Algorithms
Angioplasty, Transluminal, Percutaneous Coronary
Autopsy
Coronary Angiography
Coronary Artery Disease / diagnosis*,  metabolism,  therapy
Coronary Vessels / chemistry*,  pathology
Equipment Design
Feasibility Studies
Female
Heart Catheterization* / instrumentation
Humans
Lipids / analysis*
Male
Middle Aged
Predictive Value of Tests
Reproducibility of Results
Spectroscopy, Near-Infrared* / instrumentation
United States
Chemical
Reg. No./Substance:
0/Lipids

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Incremental prognostic value of gated Rb-82 positron emission tomography myocardial perfusion imagin...
Next Document:  Ultrasound-targeted gene delivery induces angiogenesis after a myocardial infarction in mice.