Trial Outcomes & Findings for Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases (NCT NCT01743040)

Last Updated: 2020-07-10

Results Overview

The CADence will be considered to have demonstrated effectiveness in detecting the presence of at least one lesion with ≥ 70% diameter stenosis anywhere in the proximal Left anterior Descending (pLAD), mid Left anterior Descending (mLAD), proximal Left Circumflex (pLCx), mid Left Circumflex (mLCx), proximal Right Coronary Artery (pRCA), mid Right Coronary Artery (mRCA), distal Right Coronary Artery (dRCA) and Obtuse Margin 1 (OM1), Obtuse Margin 2 (OM2), and Ramus Intermedius (RI) if segment diameter \>2.5 mm or ≥50% diameter stenosis in the Left Main coronary arteries if sensitivity and specificity are non-inferior within 15 percentage points to a sensitivity of 83% and a specificity of 80%, which is the literature-based Objective Performance Criteria (OPC) for nuclear stress tests.

Recruitment status

COMPLETED

Target enrollment

1014 participants

Primary outcome timeframe

No more than 3 weeks between CADence, SPECT and standard or CT angiogram

Results posted on

2020-07-10

Participant Flow

Recruitment was held June 14, 2013 through February 10, 2016 at hospitals, clinics and research centers.

Participant milestones

Participant milestones
Measure	Overall Study All patients enrolled in TURBULENCE study
Overall Study STARTED	1014
Overall Study CADence Testing	1013
Overall Study Nuclear Stress Test	992
Overall Study CT and/or Standard Angiogram	785
Overall Study COMPLETED	785
Overall Study NOT COMPLETED	229

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study All patients enrolled in TURBULENCE study
Overall Study Death	1
Overall Study Lost to Follow-up	66
Overall Study Physician Decision	40
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	121

Baseline Characteristics

Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=1011 Participants All patients enrolled in TURBULENCE study
Age, Continuous	59.14 years STANDARD_DEVIATION 10.650 • n=5 Participants
Sex: Female, Male Female	486 Participants n=5 Participants
Sex: Female, Male Male	525 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	728 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	116 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	116 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	26 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native American	7 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: No more than 3 weeks between CADence, SPECT and standard or CT angiogram

Population: Per protocol subjects who completed all required testing and had analyzable results. Both Sensitivity and Specificity were assessed in this study.

Outcome measures

Outcome measures
Measure	Overall Study n=763 Participants All patients enrolled in TURBULENCE study
Sensitivity and Specificity of CADence to Detect Stenosis Relative to SPECT Performance, Using Either CT or Standard Angiogram as the Gold Standard Sensitivity	78 percent Interval 76.1 to 90.8
Sensitivity and Specificity of CADence to Detect Stenosis Relative to SPECT Performance, Using Either CT or Standard Angiogram as the Gold Standard Specificity	36 percent Interval 32.0 to 39.0

Adverse Events

Overall Study

Serious events: 8 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Overall Study n=1014 participants at risk All patients enrolled in TURBULENCE study
Congenital, familial and genetic disorders Death	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Cardiac disorders Unstable Angina	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Surgical and medical procedures Laryngoscopy	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Surgical and medical procedures Knee Replacement	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Vascular disorders Pulmonary Embolism	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Injury, poisoning and procedural complications Calcaneal Fractures	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Cardiac disorders NSTEMI	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Gastrointestinal disorders Epigastric Pain	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.

Other adverse events

Other adverse events
Measure	Overall Study n=1014 participants at risk All patients enrolled in TURBULENCE study
Surgical and medical procedures CCTA-IV contrast infiltration	0.49% 5/1014 • Number of events 5 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Respiratory, thoracic and mediastinal disorders CCTA-respiratory	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Skin and subcutaneous tissue disorders CCTA-rash/hives	0.20% 2/1014 • Number of events 2 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Cardiac disorders CCTA-symptomatic bradycardia	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.
Cardiac disorders Pleurisy	0.10% 1/1014 • Number of events 1 • Adverse events were collected from the time CADence data was collected through completion of either their standard or computed tomography (CT) angiogram. The maximum time between CADence and either standard or CT angiogram was 6 weeks. An adverse event is considered serious if: 1) it results in death; 2) is life-threatening; 3) requires subject hospitalization or prolongation of existing hospitalization; 4) results in persistent or significant disability/incapacity; or 5) is an important medical event which may jeopardize the subject and may require medical or surgical intervention to prevent one of the previous outcomes.

Additional Information

Joseph Thomas, MD

UCLA Biomed

Phone: 310-222-2544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60