Trial Outcomes & Findings for Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Acute Chest Pain (NCT NCT01067456)
NCT ID: NCT01067456
Last Updated: 2017-12-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Index Hospitalization (within 48 hours)
Results posted on
2017-12-22
Participant Flow
Emergency Department, 9-month enrollment period starting January 2008
Participant milestones
| Measure |
Dedicated CT Arm
Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
|
Comprehensive Cardiothoracic CT Arm
Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Acute Chest Pain
Baseline characteristics by cohort
| Measure |
Dedicated CT Arm
n=30 Participants
Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
|
Comprehensive Cardiothoracic CT Arm
n=29 Participants
Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
Comprehensive Cardiothoracic Dual Source CT (DSCT) arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=5 Participants
|
53 years
STANDARD_DEVIATION 11 • n=7 Participants
|
51 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Index Hospitalization (within 48 hours)Outcome measures
| Measure |
Dedicated CT Arm
n=30 Participants
Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
|
Comprehensive Cardiothoracic CT Arm
n=29 Participants
Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.
|
|---|---|---|
|
Length of Hospital Stay
|
7.63 Hours
Interval 5.38 to 28.23
|
8.20 Hours
Interval 5.32 to 30.08
|
SECONDARY outcome
Timeframe: Index Hospitalization (within 48 hours)Number of patients discharged without imaging
Outcome measures
| Measure |
Dedicated CT Arm
n=30 Participants
Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
|
Comprehensive Cardiothoracic CT Arm
n=29 Participants
Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.
|
|---|---|---|
|
Direct Hospital Discharge Without Imaging
|
21 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Index Hospitalization (within 48 hours)Cost of stay in USD
Outcome measures
| Measure |
Dedicated CT Arm
n=30 Participants
Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
|
Comprehensive Cardiothoracic CT Arm
n=29 Participants
Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.
|
|---|---|---|
|
Cost of Care
|
1724 cost in USD
Interval 1277.0 to 4208.0
|
1898 cost in USD
Interval 1554.0 to 5116.0
|
Adverse Events
Dedicated CT Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Comprehensive Cardiothoracic CT Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dedicated CT Arm
n=30 participants at risk
Subjects in this arm continued to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
|
Comprehensive Cardiothoracic CT Arm
n=29 participants at risk
Subjects in this arm received a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
3.3%
1/30
|
0.00%
0/29
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place