Coronary Artery DiseasePhase 4NCT02870933

Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery

A Phase 4 study testing Transepicardial with Transseptal CD 133+ Implantation in people with Coronary Artery Disease, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: Transepicardial with Transseptal CD 133+ Implantation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteIndonesia
Study dates: Jan 2016to Apr 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients with coronary artery disease 3 vessels disease indicated for CABG
LVEF < 35% which has been confirmed by MRI
Patients with akinetic or hypokineic segment, and left ventricle myocardial hypoperfusion confirmed in MRI
has signed informed consent

Who cannot join

Emergency CABG Ungraftable coronary artery Acute myocardial Infarct (<14 days) Valve disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT > 1,5 upper normal value Creatinine > 2 g/dl. Malignancy
Drop out criteria :
Aortic cross clamp >120 minutes and CABG total time >180

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, 11420

Other trials in Indonesia

About this study

Official title: The Effect of Transepicardial Augmentation on Transseptal Autologous CD 133+ Bone Marrow Cell Implantation to Myocardial Perfusion in Patient Following Coronary Artery Bypass Grafting

Heart Failure has several etiologies and one of them is coronary artery disease. Coronary artery bypass grafting (CABG) is one of revascularizations method which has been used for decades in coronary artery disease theraphy. However, data about coronary artery bypass grafting shows that post-CABG patients still have low ejection fraction. For the last decade, there have been a lot of studies about the using of stem cells to increase heart contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells is given during CABG by injection transepicardial and transseptal. The purpose of this study is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem cells can improve myocardial perfusion in patient with low ejection fraction following CABG surgery.

Read the detailed description

Study sample : patient with low ejection fraction indicated for CABG surgery in NCCHK who fulfill inclusion and exclusion criteria

Sampling method : first we use consecutive method to find subject with male sex and age 40-70. After that, we use simple random sampling to allocate each subject to each group.

Total samples is 13 for each group. To anticipated drop out rate 10%, total sample is 15 for each group.

Intervention and measurement :

Control group will only receive CABG surgery. Study group will receive CBAG surgery and stem cell implantation. Stem cell aspiration will be performed 1 day before CABG procedure. Before aspiration, patients will be given local anesthetic and light sedation. Stem cell will be collected from posterior iliac crest. Total aspirate 190 cc. Stem cell CD133+ will be separated using CliniMACS® Magnetic Separation Device after labelled with Magnetic microbeads - anti CD133 labelling.

Myocardial perfusion reserve index will be measure using MRI. MPRI value will be obtained globally and segmentally in each 16 ventricle segments VEGF plasma level will be measured using sandwich Enzyme-linked Immunosorbent Assay method.

Ejection fraction, left ventricle dimension, and scar size will be measured using MRI.

Quality of life will be measured using Minnesota Living With Heart Failure Questionnaire.

Statistical analysis is done using IBM SPSS Statistics version 21.0 (SPSS inc, Chicago, IL, USA). Numerical data will be presented in either mean/standard deviation or median/min-max depend on distribution of data. Hypothesis test for numeric variable is done using paired/non-paired T test or Mann-Whitney/Wilcoxon depend on normality of data. Normality test is done using Shapiro-Wilk test. Hypothesis test for category varible is done using chi-square or fischer test.

Conditions: Coronary Artery Disease
Being tested: Transepicardial with Transseptal CD 133+ Implantation
Keywords: CD 133+, Transepicardial with Transseptal Implantation, CABG
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transepicardial with Transseptal CD 133+ ImplantationBiological
Transepicardial with Transseptal CD 133+ Implantation

Study groups in NCT02870933
Study group	Role	What they receive
subject	Experimental	this arm will receive Transepicardial with Transseptal CD 133+ Implantation Receives: Biological: Transepicardial with Transseptal CD 133+ Implantation
control	No intervention	this arm will not receive Transepicardial with Transseptal CD 133+ Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

Myocardial Defect Perfusion
Number of heart wall segments with perfusion defect measured by MRI.
Measured: Baseline, 6 months
Left Ventricular Ejection Fraction
Left 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%
Measured: Baseline, 6 months

Secondary outcomes (7)

Six Minutes Walking Test
Quality 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..
Measured: Baseline, 6 months
Wall Motion Score Index
Cardiac 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.
Measured: Baseline, 6 months
Myocardial Scar Size
Percentage 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)
Measured: Baseline, 6 months
Vascular Endothelial Growth Factor
Cytokine that has important role for angiogenesis. Normal range for plasma VEGF is 0-115 pg/ml
Measured: Baseline, 6 months
Left Ventricle End Systolic Volume
Left 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.
Measured: Baseline, 6 months
Minnesota Living With Heart Failure Questionnaire
Quality 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
Measured: Baseline, 6 months
Left Ventricle End Diastolic Volume
Left 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
Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Apr 2019

First posted17 Aug 2016 (estimated)
Study startJan 2016
Primary completionApr 2018
Study completionApr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02870933
Sponsor's protocol ID: LB.02.01/VII/086/KEP.007.EV
Status last verified: Mar 2020
First submitted: 7 Aug 2016
Last updated: 2 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Transepicardial Augmentation on Transseptal Autologous CD 133+ Bone Marrow Cell Implantation to Myocardial Perfusion in Patient Following Coronary Artery Bypass Grafting
ClinicalTrials.gov ID: NCT02870933
Acronym / sponsor ID: LB.02.01/VII/086/KEP.007.EV
Conditions: Coronary Artery Disease
Keywords: CD 133+, Transepicardial with Transseptal Implantation, CABG
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
Study start: Jan 2016
Primary completion: Apr 2018 (actual)
Study completion: Apr 2019 (actual)
First posted: 17 Aug 2016 (estimated)
Results: Posted 2 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study sample : patient with low ejection fraction indicated for CABG surgery in NCCHK who fulfill inclusion and exclusion criteria

Sampling method : first we use consecutive method to find subject with male sex and age 40-70. After that, we use simple random sampling to allocate each subject to each group.

Total samples is 13 for each group. To anticipated drop out rate 10%, total sample is 15 for each group.

Intervention and measurement :

Ejection fraction, left ventricle dimension, and scar size will be measured using MRI.

Quality of life will be measured using Minnesota Living With Heart Failure Questionnaire.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
subject	Experimental	Biological: Transepicardial with Transseptal CD 133+ Implantationthis arm will receive Transepicardial with Transseptal CD 133+ Implantation
control	No intervention	–this arm will not receive Transepicardial with Transseptal CD 133+ Implantation

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

patients with coronary artery disease 3 vessels disease indicated for CABG
LVEF < 35% which has been confirmed by MRI
Patients with akinetic or hypokineic segment, and left ventricle myocardial hypoperfusion confirmed in MRI
has signed informed consent

Key exclusion criteria (3 listed)

Emergency CABG Ungraftable coronary artery Acute myocardial Infarct (<14 days) Valve disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT > 1,5 upper normal value Creatinine > 2 g/dl. Malignancy
Aortic cross clamp >120 minutes and CABG total time >180

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transepicardial with Transseptal CD 133+ ImplantationTransepicardial with Transseptal CD 133+ Implantation	Biological	subject

Primary outcome

Myocardial Defect Perfusion
Time frame: Baseline, 6 months
Number of heart wall segments with perfusion defect measured by MRI.
Left Ventricular Ejection Fraction
Time frame: Baseline, 6 months
Left 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%

7 secondary outcomes

Six Minutes Walking Test
Time frame: Baseline, 6 months
Wall Motion Score Index
Time frame: Baseline, 6 months
Myocardial Scar Size
Time frame: Baseline, 6 months
Vascular Endothelial Growth Factor
Time frame: Baseline, 6 months
Left Ventricle End Systolic Volume
Time frame: Baseline, 6 months
Minnesota Living With Heart Failure Questionnaire
Time frame: Baseline, 6 months
Left Ventricle End Diastolic Volume
Time frame: Baseline, 6 months

Results and safety

Results posted to the registry on 2 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CABG + Transepicardial With Transseptal CD 133+ Implantation	15	13
Control	15	13

Primary outcome: Myocardial Defect Perfusion

Time frame: Baseline, 6 months. Mean (Standard Deviation). Unit: Percentage of Myocardial Perfusion

Measure	Transepicardial With Transseptal CD 133+ Implantation n = 13	Control n = 13
Pre-op	15.76 (4.38)	15.38 (4.87)
Post-op	2.08 (2.13)	3.85 (5.20)

Primary outcome: Left Ventricular Ejection Fraction

Time frame: Baseline, 6 months. Mean (Standard Deviation). Unit: percentage of ejection fraction

Measure	Transepicardial With Transseptal CD 133+ Implantation n = 13	Control n = 13
Pre-op	25.88 (5.66)	30.18 (3.85)
Post-op	34.58 (11.32)	31.62 (7.89)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subject	2 of 13 (15.4%)	0 of 13 (0%)	2 of 13
Control	1 of 13 (7.7%)	0 of 13 (0%)	1 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Coronary Artery Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tri Wisesa Soetisna, MD, MHA principal investigator

National Cardiovascular Center Harapan Kita

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial Defect Perfusion (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.