Trial Outcomes & Findings for Early Identification of Myocardial Impairment in PBC (NCT NCT03545672)
NCT ID: NCT03545672
Last Updated: 2024-08-09
Results Overview
All PBC patients are followed up through telephone or by retrieving outpatient medical record systems. Cardiac events include: 1. cardiac death; 2. myocardial infarction; 3. hospitalization for unstable angina.
Recruitment status
COMPLETED
Target enrollment
119 participants
Primary outcome timeframe
7 months after first CMR scanning
Results posted on
2024-08-09
Participant Flow
This was a prospective, three-center, cardiac imaging observational study. The study was open for recruitment between September 2017 and January 2019. The first participant was enrolled on October 23, 2017 and last participant was enrolled on January 8, 2019
Of 119 enrolled participants. 112 participants were included and randomized to observational study group.
Participant milestones
| Measure |
PBC Group
Patients have a definite PBC diagnosis.
Cardiac Magnetic Resonance (CMR) examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
Control Group
The healthy volunteers.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
|
Overall Study
COMPLETED
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
PBC Group
Patients have a definite PBC diagnosis.
Cardiac Magnetic Resonance (CMR) examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
Control Group
The healthy volunteers.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
|---|---|---|
|
Overall Study
Uncertain diagnosis
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
Baseline Characteristics
Early Identification of Myocardial Impairment in PBC
Baseline characteristics by cohort
| Measure |
PBC Group
n=56 Participants
Patients have a definite PBC diagnosis.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
Control Group
n=56 Participants
The healthy volunteers.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
48 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
23 kg/m^2
n=5 Participants
|
23 kg/m^2
n=7 Participants
|
23 kg/m^2
n=5 Participants
|
|
Heart rate
|
71 beats/min
n=5 Participants
|
71 beats/min
n=7 Participants
|
71 beats/min
n=5 Participants
|
|
NYHA classification of heart failure class III-IV
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Other autoimmune diseases
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Hemoglobin
|
124 g/L
n=5 Participants
|
133 g/L
n=7 Participants
|
129 g/L
n=5 Participants
|
|
Platelet
|
173 platelets *10^9/L
n=5 Participants
|
225 platelets *10^9/L
n=7 Participants
|
200 platelets *10^9/L
n=5 Participants
|
|
Serum creatinine
|
55.1 μmol/L
n=5 Participants
|
60.5 μmol/L
n=7 Participants
|
58 μmol/L
n=5 Participants
|
|
Native myocardium T1 mapping
|
1317 msec
n=5 Participants
|
1284 msec
n=7 Participants
|
1299 msec
n=5 Participants
|
|
T2 mapping
|
50 msec
n=5 Participants
|
48 msec
n=7 Participants
|
48 msec
n=5 Participants
|
|
Volume parameters
LVEDV
|
103 mL
n=5 Participants
|
107 mL
n=7 Participants
|
105 mL
n=5 Participants
|
|
Volume parameters
LVESV
|
27 mL
n=5 Participants
|
31 mL
n=7 Participants
|
28 mL
n=5 Participants
|
|
Left Ventricular Ejection Fraction
|
75 %
n=5 Participants
|
69 %
n=7 Participants
|
72 %
n=5 Participants
|
|
Myocardium Strain
GLS
|
-18.4 %
n=5 Participants
|
-17.4 %
n=7 Participants
|
-17.8 %
n=5 Participants
|
|
Myocardium Strain
GCS
|
-22.5 %
n=5 Participants
|
-20.8 %
n=7 Participants
|
-21.8 %
n=5 Participants
|
|
T2-STIR positive
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
LGE positive
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 months after first CMR scanningAll PBC patients are followed up through telephone or by retrieving outpatient medical record systems. Cardiac events include: 1. cardiac death; 2. myocardial infarction; 3. hospitalization for unstable angina.
Outcome measures
| Measure |
PBC Group
n=56 Participants
Patients have a definite PBC diagnosis.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
Control Group
n=56 Participants
The healthy volunteers.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
|---|---|---|
|
The Incidence of Cardiac Events
Cardiac death
|
0 Participants
|
0 Participants
|
|
The Incidence of Cardiac Events
Myocardial infarction
|
0 Participants
|
0 Participants
|
|
The Incidence of Cardiac Events
Hospitalization for unstable angina
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: within 2 days of CMR scanT1 mapping-derived extracellular volumes (ECV) were used to detect changes in the myocardium interstitial matrix. ECV was calculated according to the ECV formula consist of T1 mapping value.
Outcome measures
| Measure |
PBC Group
n=56 Participants
Patients have a definite PBC diagnosis.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
Control Group
n=56 Participants
The healthy volunteers.
CMR examination: After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
|
|---|---|---|
|
Quantitative Assessment in Cardiac Injury
|
30 percentage of interstitial matrix
Interval 27.0 to 32.0
|
26 percentage of interstitial matrix
Interval 25.0 to 27.0
|
Adverse Events
PBC Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Dr. Meng Jiang
Renji Hospital, Shanghai Jiaotong University School of Medicine
Phone: +86 13788912766
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place