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SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

This study has been completed.
Sponsor:
Information provided by:
InfraReDx
ClinicalTrials.gov Identifier:
NCT00330928
First received: May 26, 2006
Last updated: August 29, 2016
Last verified: August 2016
History of Changes
Results First Received: January 28, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events
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  Other Adverse Events
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  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: Manager of Clinical Research
Organization: InfraReDx, Inc
phone: 781-221-0053
e-mail: pshah@infraredx.com


Publications of Results:


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: August 29, 2016