SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

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

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

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 ]

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 ]

5.  Secondary:

Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.   [ Time Frame: 1 year ]

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.