Ischemic Heart DiseasePhase 2NCT00690209
By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy
A Phase 2 study testing Autologous bone marrow derived stem cells myocardial transplantation in people with Ischemic Heart Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Autologous bone marrow derived stem cells myocardial transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Jan 2013
- Phase
- Phase 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic ischemic heart disease
- Left ventricular dilation (end systolic volume >140 ml)
- Poor global contractile function (ejection fraction <40%)
- Substantial amount of residual viability (>30% of left ventricle)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Departements of CardiacSurgery, Cardiology and Radiology
Clermont-Ferrand
About this study
Official title: Efficacy of Surgical Coronary Revascularization Associated With Stem Cells Injection in Patients With Severe Chronic Ischemic Heart Disease With Residual Viability. A Prospective, Controlled Pilot Trial.
Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG even if substantial amount of myocardial viability is present. A value of > 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization.
Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.
Read the detailed description
The screening of patients will be performed after contrast coronar ventriculography realized for diagnostic or prognostic purpose.
Subsequently all patients will be evaluated by cardiac ce-MR and PET imaging for verification of inclusion criteria.
Patients will be allocated in a single blind manner to one of two therapeutic arms: surgical revascularization alone or surgical revascularization associated with autologous bone marrow derived stem cells injection in viable territories.
During the follow up evolution of left ventricular volumes and contractility will be analyzed by ce-MR and PET imaging at 1 year. Additionally patients' functional status will be assessed by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.
- Conditions
- Ischemic Heart Disease
- Being tested
- Autologous bone marrow derived stem cells myocardial transplantation
- Keywords
- Chronic ischemic cardiomyopathy with residual viability, surgical coronary revascularization, stem cell therapy, Chronic ischemic heart disease, severe impairment of global contractility left ventricular dilation, residual viability
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow derived stem cells myocardial transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility
Secondary outcomes (1)
Functional status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janusz Lipiecki, Dr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690209
- Sponsor's protocol ID
- CHU-0034
- Status last verified
- Jul 2014
- First submitted
- 30 May 2008
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Surgical Coronary Revascularization Associated With Stem Cells Injection in Patients With Severe Chronic Ischemic Heart Disease With Residual Viability. A Prospective, Controlled Pilot Trial.
- ClinicalTrials.gov ID
- NCT00690209
- Acronym / sponsor ID
- CHU-0034
- Conditions
- Ischemic Heart Disease
- Keywords
- Chronic ischemic cardiomyopathy with residual viability, surgical coronary revascularization, stem cell therapy, Chronic ischemic heart disease, severe impairment of global contractility left ventricular dilation, residual viability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Jun 2008 (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.
Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG even if substantial amount of myocardial viability is present. A value of > 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization.
Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.
Detailed description
The screening of patients will be performed after contrast coronar ventriculography realized for diagnostic or prognostic purpose.
Subsequently all patients will be evaluated by cardiac ce-MR and PET imaging for verification of inclusion criteria.
Patients will be allocated in a single blind manner to one of two therapeutic arms: surgical revascularization alone or surgical revascularization associated with autologous bone marrow derived stem cells injection in viable territories.
During the follow up evolution of left ventricular volumes and contractility will be analyzed by ce-MR and PET imaging at 1 year. Additionally patients' functional status will be assessed by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic ischemic heart disease
- Left ventricular dilation (end systolic volume >140 ml)
- Poor global contractile function (ejection fraction <40%)
- Substantial amount of residual viability (>30% of left ventricle)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Autologous bone marrow derived stem cells myocardial transplantation | Procedure or surgery | – |
Primary outcome
Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility
1 secondary outcome
Functional status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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.
Janusz Lipiecki, Dr principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous bone marrow derived stem cells myocardial transplantation in people with Ischemic Heart Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 0 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 8 Jul 2014. 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 France. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility. 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 8 Jul 2014.