SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00330928 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Results First Posted : May 28, 2009
Last Update Posted : January 5, 2021
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Sponsor:
InfraReDx
Information provided by:
InfraReDx
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic |
Conditions |
Angina Pectoris Angina, Unstable Myocardial Infarction |
Interventions |
Device: Near Infrared Spectroscopy (NIRS) Imaging Device: intravascular ultrasound (IVUS) |
Enrollment | 106 |
Participant Flow
Recruitment Details | Subjects were recruited from patients presenting to the cardiac catheterization laboratory for scheduled elective percutaneous coronary intervention. Subject's medical history and angiographic coronary anatomy were used to evaluate eligibility. |
Pre-assignment Details |
Arm/Group Title | Intravascular Coronary Imaging |
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Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging |
Period Title: Overall Study | |
Started | 106 [1] |
7 Day Phone Contact | 99 |
1 Year Phone Contact | 89 |
Completed | 89 |
Not Completed | 17 |
Reason Not Completed | |
Lost to Follow-up | 6 |
Physician Decision | 9 |
Death | 1 |
IVUS could not be performed. | 1 |
[1]
Subjects that signed consent and were subject to research procedures.
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Baseline Characteristics
Arm/Group Title | Intravascular Coronary Imaging | |
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Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging | |
Overall Number of Baseline Participants | 106 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 106 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
65 61.3%
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>=65 years |
41 38.7%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 106 participants | |
61.67 (9.96) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 106 participants | |
Female |
20 18.9%
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Male |
86 81.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 106 participants |
United States | 79 | |
Canada | 27 |
Outcome Measures
Adverse Events
Limitations and Caveats
Technical limits of the prototype device factored into the data set reduction(28 patients).Data made available to evaluate handling of the device(30 patients) could not be prospectively evaluated for the primary endpoint of Spectral Similarity.
More Information
Results Point of Contact
Name/Title: | Director Clinical and Regulatory |
Organization: | InfraReDx, Inc |
Phone: | 781-221-0053 |
EMail: | pshah@infraredx.com |
Responsible Party: | Director of Clinical & Regulatory Affairs, InfraReDx Inc. |
ClinicalTrials.gov Identifier: | NCT00330928 |
Other Study ID Numbers: |
0101 CL0101 |
First Submitted: | May 26, 2006 |
First Posted: | May 29, 2006 |
Results First Submitted: | January 28, 2009 |
Results First Posted: | May 28, 2009 |
Last Update Posted: | January 5, 2021 |