Trial Outcomes & Findings for Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study) (NCT NCT02515825)

Last Updated: 2021-04-08

Results Overview

Angiographically significant stenosis was defined as 70% or greater stenosis in any major coronary artery. Percent of Participants with Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as accurate and appropriate. The study is used to determine two conditions. CADence = Positive for 70% or greater stenosis and CADence = Negative for less than 70% stenosis. The pre-specified intent of this Outcome Measure was to assess all study participants combined, irrespective of whether or not they participated in the Ambience main study or the repeatability and reproducibility sub-study.

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

24 hours or discharge from hospital, whichever is sooner

Results posted on

2021-04-08

Participant Flow

Subjects \>40 years of age and scheduled for clinically-indicated angiography were recruited at 3 hospitals across the US.

Participant milestones

Participant milestones
Measure	AMBIENCE Study Participants in the initial AMBIENCE study period	AMBIENCE Plus R & R Participants in the AMBIENCE plus Repeatability and Reproducibility portion of the study
Overall Study STARTED	70	31
Overall Study COMPLETED	70	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMBIENCE n=70 Participants CADence System testing followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram	AMBIENCE Plus R&R Substudy n=31 Participants CADence System testing for repeatability and reproducibility (4x by 2 operators) followed by coronary angiogram CADence System: Obtain CADence data under normal conditions for comparison of results with those of coronary angiogram. This part of the study includes patients who are a part of the AMBIENCE study.	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	18 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	13 Participants n=7 Participants	37 Participants n=5 Participants
Age, Continuous	63.14 years STANDARD_DEVIATION 8.82 • n=5 Participants	64.65 years STANDARD_DEVIATION 11.14 • n=7 Participants	63.60 years STANDARD_DEVIATION 9.56 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	6 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	25 Participants n=7 Participants	72 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	55 Participants n=5 Participants	23 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours or discharge from hospital, whichever is sooner

Population: The Ambience study included a sub-study within the same population. The sub-study was to evaluate the repeatability and reproducibility of the CADence System. Repeatability refers to the ability of the same System operator to obtain the same results each time the same subject is tested with the same System at two points in time. Reproducibility refers to the ability of different operators to obtain the same results when they evaluate the same subjects with either the same or different Systems.

Outcome measures

Outcome measures
Measure	Patient CADence Result n=101 Participants CADence System testing followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram	Repeatability and Reproducibility n=31 Participants The purpose of the study is to collect performance information regarding the use of the CADence system under normal conditions of use. Includes a 31-subject sub-study to assess the repeatability and reproducibility of the CADence system
Percent of Participants With Positive Agreement of CADence Device Under Normal Use Conditions as Compared to Coronary Angiograms as Accurate and Appropriate	101 Participants	31 Participants

SECONDARY outcome

Timeframe: 24 hours or discharge from hospital, whichever is sooner

Population: All participants were assessed and none had adverse events

Outcome measures

Outcome measures
Measure	Patient CADence Result n=101 Participants CADence System testing followed by coronary angiogram CADence System: Obtain CADence data under normal conditions of use for comparison of results with those of coronary angiogram	Repeatability and Reproducibility The purpose of the study is to collect performance information regarding the use of the CADence system under normal conditions of use. Includes a 31-subject sub-study to assess the repeatability and reproducibility of the CADence system
Number of Participants With CADence-related Adverse Events Adverse Events	0 Participants	—
Number of Participants With CADence-related Adverse Events No adverse events	101 Participants	—

Adverse Events

AMBIENCE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AMBIENCE Plus R&R Substudy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie Johnson, PhD

AUM Cardiovascular

Phone: 612.799.2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60