Trial Outcomes & Findings for Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery (NCT NCT02870933)
NCT ID: NCT02870933
Last Updated: 2020-04-02
Results Overview
Number of heart wall segments with perfusion defect measured by MRI.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2020-04-02
Participant Flow
Participant milestones
| Measure |
CABG + Transepicardial With Transseptal CD 133+ Implantation
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
Control
this arm will receive CABG only
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
CABG + Transepicardial With Transseptal CD 133+ Implantation
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
Control
this arm will receive CABG only
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CABG + Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive Transepicardial with Transseptal CD 133+ Implantation
|
Control
n=13 Participants
this arm will not receive Transepicardial with Transseptal CD 133+ Implantation
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.92 years
STANDARD_DEVIATION 8.95 • n=13 Participants
|
57.46 years
STANDARD_DEVIATION 6.33 • n=13 Participants
|
56.69 years
STANDARD_DEVIATION 7.63 • n=26 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=13 Participants
|
12 Participants
n=13 Participants
|
24 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Indonesia
|
13 participants
n=13 Participants
|
13 participants
n=13 Participants
|
26 participants
n=26 Participants
|
|
Systolic blood pressure
|
121.92 mmHg
STANDARD_DEVIATION 14.37 • n=13 Participants
|
126.5 mmHg
STANDARD_DEVIATION 19.60 • n=13 Participants
|
123.38 mmHg
STANDARD_DEVIATION 17.51 • n=26 Participants
|
|
Diastolic blood pressure
|
78.00 mmHg
STANDARD_DEVIATION 12.03 • n=13 Participants
|
72.46 mmHg
STANDARD_DEVIATION 15.36 • n=13 Participants
|
75.04 mmHg
STANDARD_DEVIATION 13.52 • n=26 Participants
|
|
Smoking
|
11 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
20 Participants
n=26 Participants
|
|
Dyslipidemia
|
6 Participants
n=13 Participants
|
11 Participants
n=13 Participants
|
17 Participants
n=26 Participants
|
|
Hypertension
|
9 Participants
n=13 Participants
|
7 Participants
n=13 Participants
|
16 Participants
n=26 Participants
|
|
Menopause
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Diabetes
|
5 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
14 Participants
n=26 Participants
|
|
Random blood sugar level
|
126.85 mg/dl
STANDARD_DEVIATION 38.89 • n=13 Participants
|
136.85 mg/dl
STANDARD_DEVIATION 39.0 • n=13 Participants
|
131.85 mg/dl
STANDARD_DEVIATION 38.50 • n=26 Participants
|
|
NYHA grade III-IV
|
3 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
7 Participants
n=26 Participants
|
|
CCS grade III-IV
|
1 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
3 Participants
n=26 Participants
|
|
Six minutes walk test
|
297.08 meters
STANDARD_DEVIATION 72.56 • n=13 Participants
|
308.92 meters
STANDARD_DEVIATION 79.37 • n=13 Participants
|
303.0 meters
STANDARD_DEVIATION 74.75 • n=26 Participants
|
|
Left Ventricle Ejection Fraction
|
25.88 Percentage of Ejection Fraction
STANDARD_DEVIATION 5.66 • n=13 Participants
|
30.18 Percentage of Ejection Fraction
STANDARD_DEVIATION 3.85 • n=13 Participants
|
28.03 Percentage of Ejection Fraction
STANDARD_DEVIATION 5.23 • n=26 Participants
|
|
Left Ventricle End-Systolic Volume
|
115.87 mililiters
STANDARD_DEVIATION 35.94 • n=13 Participants
|
141.05 mililiters
STANDARD_DEVIATION 27.77 • n=13 Participants
|
128.46 mililiters
STANDARD_DEVIATION 33.99 • n=26 Participants
|
|
Left Ventricle End-Diastolic Volume
|
156.10 mililiters
STANDARD_DEVIATION 47.46 • n=13 Participants
|
200.89 mililiters
STANDARD_DEVIATION 37.10 • n=13 Participants
|
178.5 mililiters
STANDARD_DEVIATION 47.58 • n=26 Participants
|
|
Myocardial Scar Size
|
27.76 Percentage of Scar Area
STANDARD_DEVIATION 15.76 • n=13 Participants
|
24.45 Percentage of Scar Area
STANDARD_DEVIATION 13.73 • n=13 Participants
|
26.11 Percentage of Scar Area
STANDARD_DEVIATION 14.58 • n=26 Participants
|
|
Myocardial perfusion defect
|
15.76 Percentage of Myocardial Perfusion
STANDARD_DEVIATION 4.38 • n=13 Participants
|
15.38 Percentage of Myocardial Perfusion
STANDARD_DEVIATION 4.87 • n=13 Participants
|
15.57 Percentage of Myocardial Perfusion
STANDARD_DEVIATION 4.62 • n=26 Participants
|
|
Wall motion score index
|
2.32 units on a scale
STANDARD_DEVIATION 0.17 • n=13 Participants
|
2.07 units on a scale
STANDARD_DEVIATION 0.31 • n=13 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.28 • n=26 Participants
|
|
Minnesotta Living with Heart Failure Score
|
30.3 units on a scale
STANDARD_DEVIATION 13.73 • n=13 Participants
|
21.46 units on a scale
STANDARD_DEVIATION 8.76 • n=13 Participants
|
25.88 units on a scale
STANDARD_DEVIATION 12.16 • n=26 Participants
|
|
Vascular Endothelial Growth Factor
|
46.86 pg/mL
STANDARD_DEVIATION 141.20 • n=13 Participants
|
40.46 pg/mL
STANDARD_DEVIATION 40.08 • n=13 Participants
|
43.66 pg/mL
STANDARD_DEVIATION 101.75 • n=26 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsNumber of heart wall segments with perfusion defect measured by MRI.
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Myocardial Defect Perfusion
Pre-op
|
15.38 Percentage of Myocardial Perfusion
Standard Deviation 4.87
|
15.76 Percentage of Myocardial Perfusion
Standard Deviation 4.38
|
|
Myocardial Defect Perfusion
Post-op
|
3.85 Percentage of Myocardial Perfusion
Standard Deviation 5.20
|
2.08 Percentage of Myocardial Perfusion
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsLeft ventricular ejection fraction (LVEF) measured by MRI. Normal range of LVEF ranges from 50% to 70%. Borderline LVEF ranges from 41% to 49% Reduced LVEF ranges \< 41%
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Left Ventricular Ejection Fraction
Post-op
|
31.62 percentage of ejection fraction
Standard Deviation 7.89
|
34.58 percentage of ejection fraction
Standard Deviation 11.32
|
|
Left Ventricular Ejection Fraction
Pre-op
|
30.18 percentage of ejection fraction
Standard Deviation 3.85
|
25.88 percentage of ejection fraction
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsQuality of life will be assessed using Six minutes walking test, to see the changes of six minutes walking test before and after intervention Distances reported for healthy individuals ages 40 yo 85 years range from 400 to 700 m..
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Six Minutes Walking Test
Pre-op
|
298 meters
Interval 255.0 to 371.0
|
299 meters
Interval 260.5 to 350.0
|
|
Six Minutes Walking Test
Post-op
|
378 meters
Interval 335.0 to 414.5
|
420 meters
Interval 381.0 to 441.0
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsCardiac wall motion abnormality will be measured using Wall Motion Score Index with MRI. Each myocardial segment is assigned a score from 1 to 4. The 16 segment model of myocardial segmentation is recommended. A WMSI of 1.0 is considered normokinetic. A WMSI of 1.5 is considered mild hypokinesia A WMSI of 2.0 is considered hypokinesia A WMSI of 2.5 is considered severe hypokinesia A WMSI of 3.0 is considered akinetic.
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Wall Motion Score Index
Pre-op
|
2.07 score on a scale
Standard Deviation 0.31
|
2.32 score on a scale
Standard Deviation 0.17
|
|
Wall Motion Score Index
Post-op
|
2.08 score on a scale
Standard Deviation 0.28
|
1.82 score on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPercentage of myocardial scar size proportion measured by MRI to quantify and define the extent/transmurality of scar tissue, the following definitions were used 1. spatial (circumferential) extent, the number of affected segments 2. nontransmurality, the number of segmments with a segmental scar score of 1 or 2, and transmurality, the number of segments with a segmental scar score of 3 or 4 3. total score, summed segmental scar scores per patient divided by 17 (which reflects the damage per patient)
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Myocardial Scar Size
Pre op
|
24.45 Percentage of Scar Area
Standard Deviation 13.73
|
27.76 Percentage of Scar Area
Standard Deviation 15.76
|
|
Myocardial Scar Size
Post op
|
27.32 Percentage of Scar Area
Standard Deviation 12.92
|
25.46 Percentage of Scar Area
Standard Deviation 12.91
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsCytokine that has important role for angiogenesis. Normal range for plasma VEGF is 0-115 pg/ml
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Vascular Endothelial Growth Factor
Pre-op
|
40.46 pg/ml
Standard Deviation 40.08
|
46.86 pg/ml
Standard Deviation 141.20
|
|
Vascular Endothelial Growth Factor
Post-op
|
19.88 pg/ml
Standard Deviation 33.78
|
61.05 pg/ml
Standard Deviation 63.01
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsLeft ventricle end-systolic volume is the volume of blood in a left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. Normal LVESV ranges is 37 - 57 mililiters.
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Left Ventricle End Systolic Volume
Pre-op LVESV
|
141.05 milliliters
Standard Deviation 7.77
|
115.87 milliliters
Standard Deviation 35.94
|
|
Left Ventricle End Systolic Volume
Post-op LVESV
|
149.33 milliliters
Standard Deviation 44.96
|
126.91 milliliters
Standard Deviation 86.03
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsQuality of life assessed using Minnesota Living With Heart Failure Questionnaire consist of 21 questions, to see the changes before and after intervention. Minimum score = 0, Maximum score = 105 Higher values represent a worse outcome
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Minnesota Living With Heart Failure Questionnaire
Pre-op
|
23 score on a scale
Interval 15.0 to 26.0
|
27 score on a scale
Interval 20.0 to 39.5
|
|
Minnesota Living With Heart Failure Questionnaire
Post-op
|
14 score on a scale
Interval 4.5 to 15.5
|
12 score on a scale
Interval 4.5 to 16.0
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsLeft ventricle end-diastolic volume is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole. Normal ranges of LVEDV is 121 - 163 mililiters
Outcome measures
| Measure |
Control
n=13 Participants
this arm will receive CABG only
|
Transepicardial With Transseptal CD 133+ Implantation
n=13 Participants
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
|---|---|---|
|
Left Ventricle End Diastolic Volume
Pre-op LVEDV
|
200.89 milliliters
Standard Deviation 37.10
|
156.10 milliliters
Standard Deviation 47.46
|
|
Left Ventricle End Diastolic Volume
Post-op LVEDV
|
219.97 milliliters
Standard Deviation 35.64
|
183.68 milliliters
Standard Deviation 94.99
|
Adverse Events
Subject
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Subject
n=13 participants at risk
this arm will receive CABG + Transepicardial with Transseptal CD 133+ Implantation
|
Control
n=13 participants at risk
this arm will receive CABG only
|
|---|---|---|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • 6 months
|
7.7%
1/13 • 6 months
|
|
General disorders
Haemodynamic instability
|
7.7%
1/13 • 6 months
|
0.00%
0/13 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Tri Wisesa Soetisna, M.D, MHA, PhD
National Cardiovascular Center Harapan Kita
Phone: +62215684093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place