Trial Outcomes & Findings for SPECTACL: SPECTroscopic Assessment of Coronary Lipid (NCT NCT00330928)

Results Overview

Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was \>=67%, on a continuous range of 0%(different) to 100%(identical) similarity.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

106 participants

Primary outcome timeframe

Baseline

Results posted on

2021-01-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Intravascular Coronary Imaging Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Overall Study STARTED	106
Overall Study 7 Day Phone Contact	99
Overall Study 1 Year Phone Contact	89
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Intravascular Coronary Imaging Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Overall Study Lost to Follow-up	6
Overall Study Physician Decision	9
Overall Study Death	1
Overall Study IVUS could not be performed.	1

Baseline Characteristics

SPECTACL: SPECTroscopic Assessment of Coronary Lipid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravascular Coronary Imaging n=106 Participants Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants
Age, Continuous	61.67 years STANDARD_DEVIATION 9.96 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants
Region of Enrollment United States	79 participants n=5 Participants
Region of Enrollment Canada	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 58 Subjects were excluded from endpoint analysis for No NIRS data(17), Inadequate data per protocol(11), and Data Accessible during comparison set generation(30).A similarity success was met if \>80% of the NIRS data for a subject was similar to the autopsy NIRS set.

Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was \>=67%, on a continuous range of 0%(different) to 100%(identical) similarity.

Outcome measures

Outcome measures
Measure	Intravascular Coronary Imaging n=48 Participants Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Spectral Similarity	83 percent similarity Interval 70.0 to 93.0

SECONDARY outcome

Timeframe: Baseline

This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 7 day

Population: All patients that were enrolled, intent to treat population, were evaluated for definite or probable relation to the investigational device. This includes 7 subjects that were not exposed to the investigational device.

Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.

Outcome measures

Outcome measures
Measure	Intravascular Coronary Imaging n=106 Participants Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment Myocardial Infarction	0 participants
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment Target Vessel Revascularization	0 participants
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment Death	0 participants
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment Cerebral Vascular Accident	0 participants

SECONDARY outcome

Timeframe: 1 year

Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.

Outcome measures

Outcome data not reported

Adverse Events

Intravascular Coronary Imaging

Serious events: 10 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intravascular Coronary Imaging Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Cardiac disorders Myocardial Infarction	7.5% 8/106 • Number of events 9
Nervous system disorders Cerebral Vascular Accident	0.94% 1/106 • Number of events 1
Cardiac disorders Death	0.94% 1/106 • Number of events 1

Other adverse events

Other adverse events
Measure	Intravascular Coronary Imaging Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Cardiac disorders Chest Pain/Shortness of Breath	18.9% 20/106 • Number of events 28

Additional Information

Director Clinical and Regulatory

InfraReDx, Inc

Phone: 781-221-0053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60