Trial Outcomes & Findings for Coronary Flow Reserve to Assess Cardiovascular Inflammation (CIRT-CFR) (NCT NCT02786134)
NCT ID: NCT02786134
Last Updated: 2021-01-06
Results Overview
Change (from baseline) in global coronary flow reserve in response to vasodilator as measured by PET imaging at baseline and at one year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
12 months
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
Low-Dose Methotrexate (LDM)
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
Placebo
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coronary Flow Reserve to Assess Cardiovascular Inflammation (CIRT-CFR)
Baseline characteristics by cohort
| Measure |
Low-dose Methotrexate (LDM)
n=25 Participants
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
Placebo
n=25 Participants
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Age, Continuous
|
66 years
n=93 Participants
|
63 years
n=4 Participants
|
65 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
13 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
24 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsChange (from baseline) in global coronary flow reserve in response to vasodilator as measured by PET imaging at baseline and at one year
Outcome measures
| Measure |
Low-Dose Methotrexate (LDM)
n=25 Participants
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
Placebo
n=25 Participants
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
|---|---|---|
|
Change in Global Myocardial Blood Flow in Response to Vasodilator
|
0.05 percentage change in CFR
Interval -0.192 to 0.288
|
-0.145 percentage change in CFR
Interval -0.429 to 0.117
|
Adverse Events
Low-Dose Methotrexate (LDM)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low-Dose Methotrexate (LDM)
n=25 participants at risk
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dipyridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
Placebo
n=25 participants at risk
Patients willing to participate in CIRT will be asked to enroll into the sub-study and may sign the CIRT-CFR informed consent at any point between signing the parent CIRT informed consent and completing the parent CIRT randomization visit (Visit 4). After giving informed consent for the ancillary CIRT-CFR, patients will undergo the baseline rest/dypridamole stress PET scan along with echocardiography. The final PET scan and echocardiogram will occur at approximately 12 months after randomization.
PET scan: A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
Echocardiogram: An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
|
|---|---|---|
|
Cardiac disorders
Shortness of Breath during PET scan
|
0.00%
0/25 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
8.0%
2/25 • Number of events 2 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
|
Cardiac disorders
Headache during PET scan
|
0.00%
0/25 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
4.0%
1/25 • Number of events 2 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
|
Cardiac disorders
Chest Pain during PET scan
|
8.0%
2/25 • Number of events 3 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
0.00%
0/25 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
|
Blood and lymphatic system disorders
Swelling at IV site
|
4.0%
1/25 • Number of events 1 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
0.00%
0/25 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
|
Cardiac disorders
Developed atrial fibrillation
|
4.0%
1/25 • Number of events 1 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
0.00%
0/25 • 1 year
The adverse definitions match those listed on clincaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place