SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

Study Type:	Interventional
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)

  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
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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.
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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 ]

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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 ]

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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.

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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: 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. 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. 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:

Waxman S, Dixon SR, L'Allier P, Moses JW, Petersen JL, Cutlip D, Tardif JC, 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 of the SPECTACL study. JACC Cardiovasc Imaging. 2009 Jul;2(7):858-68. doi: 10.1016/j.jcmg.2009.05.001.

Responsible Party:	Director of Clinical & Regulatory Affairs, InfraReDx Inc.
ClinicalTrials.gov Identifier:	NCT00330928 History of Changes
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:	October 10, 2016