SPECTACL: SPECTroscopic Assessment of Coronary Lipid

This study has been completed.
Sponsor:
Information provided by:
InfraReDx
ClinicalTrials.gov Identifier:
NCT00330928
First received: May 26, 2006
Last updated: July 14, 2009
Last verified: July 2009
Results First Received: January 28, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Angina Pectoris
Angina, Unstable
Myocardial Infarction
Interventions: Device: Near Infrared Spectroscopy (NIRS) Imaging
Device: intravascular ultrasound (IVUS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intravascular Coronary Imaging Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging

Participant Flow:   Overall Study
    Intravascular Coronary Imaging  
STARTED     106 [1]
7 Day Phone Contact     99  
1 Year Phone Contact     89  
COMPLETED     89  
NOT COMPLETED     17  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intravascular Coronary Imaging Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging

Baseline Measures
    Intravascular Coronary Imaging  
Number of Participants  
[units: participants]
  106  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     65  
>=65 years     41  
Age  
[units: years]
Mean ± Standard Deviation
  61.67  ± 9.96  
Gender  
[units: participants]
 
Female     20  
Male     86  
Region of Enrollment  
[units: participants]
 
United States     79  
Canada     27  



  Outcome Measures
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1.  Primary:   Spectral Similarity   [ Time Frame: Baseline ]

2.  Secondary:   Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment   [ Time Frame: Baseline to 7 day ]

3.  Secondary:   Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes   [ Time Frame: Baseline ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics   [ Time Frame: Baseline ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Project Manager
Organization: InfraReDx, Inc
phone: 781-221-0053 ext 611
e-mail: mhendricks@infraredx.com


Publications of Results:
Waxman S, Simon R. Dixon, L'Allier P, Moses JW, Petersen JL, Cutlip D, Tardif J, Nesto RW, Muller JE, Hendricks MJ, Sum ST, Gardner CM, Goldstein JA, Stone GW, Krucoff MW. In Vivo Validation of a Catheter-Based Near-Infrared Spectroscopy System for Detection of Lipid Core Coronary Plaques: Initial Results and Exploratory Analysis of the Spectroscopic Assessment of Coronary Lipid (SPECTACL) Multicenter Study. J Am Coll Cardiol Img. 2009; 2: 858-868.

Publications automatically indexed to this study:

Responsible Party: Director of Clinical & Regulatory Affairs, InfraReDx Inc.
ClinicalTrials.gov Identifier: NCT00330928     History of Changes
Other Study ID Numbers: 0101, CL0101
Study First Received: May 26, 2006
Results First Received: January 28, 2009
Last Updated: July 14, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada