Trial Outcomes & Findings for The Computed Tomography-derived Fractional Flow Reserve STAT Trial (NCT NCT03263806)
NCT ID: NCT03263806
Last Updated: 2018-07-03
Results Overview
Percent of patients undergoing heart catheterization
TERMINATED
NA
13 participants
3 months after initial presentation
2018-07-03
Participant Flow
Emergency department patients who had a Cardiac CT scan, were screened for the study. The doctors interpreting the CT scan notifies the research coordinator regarding potential eligibility of the patient to the study.
Participant milestones
| Measure |
SOC Group Management
Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
|
CTFFR-Guided Group Management
Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
SOC Group Management
Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
|
CTFFR-Guided Group Management
Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.
|
|---|---|---|
|
Overall Study
Elevated Troponin (failed screen)
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Study Termination
|
5
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SOC Group Management
n=5 Participants
Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.
SOC Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
|
CTFFR-Guided Group Management
n=6 Participants
Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.
CTFFR-Guided Group Management: Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
60.5 years
n=6 Participants
|
57 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 3 months after initial presentationPopulation: Study terminated with NO data collected.
Percent of patients undergoing heart catheterization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months after initial presentationPopulation: Study terminated with NO data collected.
Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year after presentationPopulation: Study terminated with NO data collected.
Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: An average of 2 daysPopulation: Study terminated with NO data collected.
Time from admission to discharge from hospital in days
Outcome measures
Outcome data not reported
Adverse Events
SOC Group Management
CTFFR-Guided Group Management
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place