Ischemic CardiomyopathyPhase 1/2NCT00972114
CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy
A Phase 1/2 study testing CABG combined cardiomyoplasty, CABG combined pedicled omentum graft and CABG alone in people with Ischemic Cardiomyopathy and Congestive Heart Failure, run by China National Center for Cardiovascular Diseases at 2 sites in China.
Trial summary
The purpose of this study is in a phase I/II safety and efficacy study to evaluate the clinical effect of coronary artery bypass graft (CABG) combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Ischemic Cardiomyopathy, Congestive Heart Failure, Coronary Artery Disease
- What is being tested?
- CABG combined cardiomyoplasty, CABG combined pedicled omentum graft and CABG alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female;
- 20-70 years old;
- Ability to give informed consent;
- Documented severe coronary heart disease, defined as at least 70% luminal diameter narrowing of at least three major coronary artery, suited to CABG;
- Left ventricular dysfunction (LVEF) less than or equal to 35%, measured by MRI or less than or equal to 45%, measured by echocardiogram;
- Presence of reversibility, as identified by single photon emission computed tomography (SPECT) isotope protocol;
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- At least 3 months since last episode of myocardial infarction;
- Without a history of abdominal operation and severe abdominal diseases;
- Negative pregnancy test (in women with childbearing potential.
Who cannot join
- Pregnant or lactating;
- A history of malignancy in the last 5 years excluding basal cell carcinoma, that has been surgically removed, with proof of surgical clean margins;
- a history of abdominal operation or severe abdominal diseases;
- Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Any condition requiring immunosuppressive medication;
- Bleeding diathesis, defined as an international normalized ratio of at least 2.0 in the absence of warfarin therapy;
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- Hepatic dysfunction, as defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal range prior to study entry;
- Chronic renal insufficiency, defined as a serum creatinine level greater than 2.5 mg/dL or requiring dialysis;
- Leukocytes less than 4,000/µL or exceeding 10,000/µL;
- Platelets less than 100,000/µL;
- Hemoglobin less than 10 g/dL;
- Chronic atrial fibrillation;
- Less than 3 months since last episode of cerebral infarction;
- Implantable cardioverter-defibrillator shock within 30 days of baseline consent, and within 30 days of randomization;
- Presence of ventricular tachycardia lasting 30 seconds or more on 24-hour Holter monitor or electrocardiogram (ECG) performed during screening period;
- Patients for whom it is impossible to perform both cardiac MRI;
- Enrolled in an investigational device or drug study within the previous1 year;
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
Beijing, 100037
Jianfeng Hou, M.D., Ph.D., +86 10 88398359, hjf2006111@163.com
- Not yet recruiting
Institute of cardiovascular diseases & Fuwai hospital
Beijing, 100037
Shengshou Hu, MD, 0086-10-8839-8359, shengshouhu@yahoo.com
Jianfeng Hou, MD, PhD, 0086-10-8839-8359, hjf2006111@163.com
About this study
Official title: Coronary Artery Bypass Graft Surgery Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Patients With Ischemic Cardiomyopathy: a Prospective Randomized Controlled Clinical Trial
The purpose of this study is in a phase I/II safety and efficacy study to evaluate the clinical effect of coronary artery bypass graft (CABG) combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy.
Read the detailed description
This is a phase I/II, randomized controlled trial to evaluate the use of CABG combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy. The study hypothesis is that the combined surgical technique to perform pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty as adjunct to CABG, is safe to patients with severe ischemic heart failure and can improve regional myocardial perfusion contractility, which resulting in improved systolic and diastolic left ventricular function.
The primary object of this study will be to evaluate the safety and efficacy of this novel combined surgical technique. The efficacy will be assessed changes in left ventricular ejection fraction by MRI. The secondary endpoint of the study is to assess the effects of this novel combined surgical technique on cardiac contractile function and functional outcome. The effects will be assessed on the basis of clinical status and imaging rests in 6 month follow-up after enrollment. A maximum of 60 patients between 20 and 70 years will be enrolled in the study. These participants will be randomized to receive CABG, pedicled omentum graft combined CABG, or pedicled omentum graft autologous atrial tissue patch cardiomyoplasty combined CABG. The objective evaluations will be performed at baseline and during 6 months follow-up.
- Being tested
- CABG combined cardiomyoplasty, CABG combined pedicled omentum graft, CABG alone
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG combined cardiomyoplastyProcedure or surgery
Also called CABG combined pedicled omentum graft
coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty
CABG combined pedicled omentum graftProcedure or surgery
Coronary artery bypass graft surgery combined pedicled omentum graft
CABG aloneProcedure or surgery
Also called Coronary artery bypass graft surgery alone
Coronary artery bypass graft surgery alone
| Study group | Role | What they receive |
|---|---|---|
| CABG combined cardiomyoplasty | Experimental | Coronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty Receives: Procedure: CABG combined cardiomyoplasty |
| CABG combined pedicled omentum graft | Active comparator | Coronary artery bypass graft surgery combined pedicled omentum graft Receives: Procedure: CABG combined pedicled omentum graft |
| CABG alone | Active comparator | Coronary artery bypass graft surgery alone Receives: Procedure: CABG alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CABG combined pedicled omentum wrapped autologous atrial tissue transplantation.
Measured: 6 months
Changes in left ventricular ejection fraction (LVEF) by MRI.
Measured: 6 months
Secondary outcomes (5)
Changes in LVEF by echocardiography.
Measured: 6 months
Changes in regional wall motion by MRI.
Measured: 6 months
Changes in regional wall motion by echocardiography.
Measured: 6 months
Changes in fixed perfusion defect(s) by single photon emission computed tomography.
Measured: 6 months
Clinical improvements, including change in 6 minutes walk test, as determined by multiple measures.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Investigators
- Shengshou Hu, MD, Study director, National Center for Cardiovascular Diseases, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972114
- Sponsor's protocol ID
- 20090903
- Status last verified
- Dec 2009
- First submitted
- 3 Sep 2009
- Last updated
- 10 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Bypass Graft Surgery Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Patients With Ischemic Cardiomyopathy: a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00972114
- Acronym / sponsor ID
- 20090903
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is in a phase I/II safety and efficacy study to evaluate the clinical effect of coronary artery bypass graft (CABG) combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy.
Detailed description
This is a phase I/II, randomized controlled trial to evaluate the use of CABG combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy. The study hypothesis is that the combined surgical technique to perform pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty as adjunct to CABG, is safe to patients with severe ischemic heart failure and can improve regional myocardial perfusion contractility, which resulting in improved systolic and diastolic left ventricular function.
The primary object of this study will be to evaluate the safety and efficacy of this novel combined surgical technique. The efficacy will be assessed changes in left ventricular ejection fraction by MRI. The secondary endpoint of the study is to assess the effects of this novel combined surgical technique on cardiac contractile function and functional outcome. The effects will be assessed on the basis of clinical status and imaging rests in 6 month follow-up after enrollment. A maximum of 60 patients between 20 and 70 years will be enrolled in the study. These participants will be randomized to receive CABG, pedicled omentum graft combined CABG, or pedicled omentum graft autologous atrial tissue patch cardiomyoplasty combined CABG. The objective evaluations will be performed at baseline and during 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CABG combined cardiomyoplasty | Experimental | Procedure: CABG combined cardiomyoplastyCoronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty |
| CABG combined pedicled omentum graft | Active comparator | Procedure: CABG combined pedicled omentum graftCoronary artery bypass graft surgery combined pedicled omentum graft |
| CABG alone | Active comparator | Procedure: CABG aloneCoronary artery bypass graft surgery alone |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female;
- 20-70 years old;
- Ability to give informed consent;
- Documented severe coronary heart disease, defined as at least 70% luminal diameter narrowing of at least three major coronary artery, suited to CABG;
- Left ventricular dysfunction (LVEF) less than or equal to 35%, measured by MRI or less than or equal to 45%, measured by echocardiogram;
Key exclusion criteria (18 listed)
- Pregnant or lactating;
- A history of malignancy in the last 5 years excluding basal cell carcinoma, that has been surgically removed, with proof of surgical clean margins;
- a history of abdominal operation or severe abdominal diseases;
- Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Any condition requiring immunosuppressive medication;
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 |
|---|---|---|
| CABG combined cardiomyoplastyAlso: CABG combined pedicled omentum graftcoronary artery bypass graft surgery combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty | Procedure or surgery | CABG combined cardiomyoplasty |
| CABG combined pedicled omentum graftCoronary artery bypass graft surgery combined pedicled omentum graft | Procedure or surgery | CABG combined pedicled omentum graft |
| CABG aloneAlso: Coronary artery bypass graft surgery aloneCoronary artery bypass graft surgery alone | Procedure or surgery | CABG alone |
Primary outcome
Safety of CABG combined pedicled omentum wrapped autologous atrial tissue transplantation.
Time frame: 6 months
Changes in left ventricular ejection fraction (LVEF) by MRI.
Time frame: 6 months
5 secondary outcomes
Changes in LVEF by echocardiography.
Time frame: 6 months
Changes in regional wall motion by MRI.
Time frame: 6 months
Changes in regional wall motion by echocardiography.
Time frame: 6 months
Changes in fixed perfusion defect(s) by single photon emission computed tomography.
Time frame: 6 months
Clinical improvements, including change in 6 minutes walk test, as determined by multiple measures.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2009.
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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.
China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
Beijing, China
Institute of cardiovascular diseases & Fuwai hospital
Beijing, China
Shengshou Hu, MD study director
National Center for Cardiovascular Diseases, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CABG combined cardiomyoplasty, CABG combined pedicled omentum graft and CABG alone in people with Ischemic Cardiomyopathy and Congestive Heart Failure, run by China National Center for Cardiovascular Diseases at 2 sites in China.
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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 10 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CABG combined pedicled omentum wrapped autologous atrial tissue transplantation. (time frame: 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?
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 10 Dec 2009; AzTrials last refreshed its copy on 8 Nov 2026.