Ischemic Heart DiseasePhase 3NCT00362388
Cell Therapy in Chronic Ischemic Heart Disease
A Phase 3 study testing Intramyocardial injection of autologous bone marrow cells in people with Ischemic Heart Disease and Coronary Artery Disease, run by Ministry of Health, Brazil at 6 sites in Brazil.
Trial summary
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Disease
- What is being tested?
- Intramyocardial injection of autologous bone marrow cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 6 sitesBrazil
- Study dates
- Jan 2006to Nov 2008
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (CAD) referred for CABG.
- Echocardiogram-assessed LVEF between 25 and 55% (Simpson's rule).
- Angina (or equivalent) functional class II to IV (Canadian Cardiovascular Society) despite maximally tolerated medical therapy.
- Abnormal myocardial perfusion tests:
- Cardiac scintigraphy ii. Magnetic resonance imaging iii. Dobutamine-atropine stress-echocardiogram
- Non-candidates for a percutaneous coronary intervention (PCI) due to ANY of the following:
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- High risk lesion ii. Extensive lesion iii. Diffuse, small vessel disease
- Non-candidates for a complete CABG, or candidates for a complete CABG in whom, according to an expert panel, there is a high probability of failure of the grafts due to the extension and severity of the disease, with diffuse, small vessel involvement.
- To provide a signed, written informed consent, according to the National Guidelines for Clinical Trials.
Who cannot join
- Severe valve heart disease requiring surgical repair.
- Serologic diagnostic of Chagas' disease.
- Symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
- Malignant ventricular arrhythmias (like VT), unless an ICD have been placed.
- Any acute coronary syndrome in the past 3 months.
- End-stage renal disease requiring maintenance dialysis.
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- History of neoplasia.
- Drug or alcohol abuse.
- Life expectancy below 2 years.
- Enrollment in any cell therapy trial in the past 2 years.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Irmandade da Santa Casa de Misericórdia
Curitiba, Paraná, 80010-030
Clínica Cardiologyca C. Constantini
Curitiba, Paraná, 80320-320
Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência
Recife, Pernambuco, 52010-040
Instituto Nacional de Cardiologia Laranjeiras (INCL)
Rio de Janeiro, Rio de Janeiro, 22240-002
Hospital Pró-Cardíaco
Rio de Janeiro, Rio de Janeiro, 22280-000
Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School
São Paulo, São Paulo, 05403-900
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath.
Read the detailed description
Severe ischemic heart disease (IHD) remains a clinical challenge; many patients with IHD have undergone myocardial revascularization procedures (either percutaneous or surgical) but still remain symptomatic despite maximally tolerated medical therapy. Others are considered non-optimal candidates for a complete myocardial revascularization procedure due to the extension and diffuseness of the disease.
Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for many cardiovascular diseases, including heart failure, acute myocardial infarction, chronic ischemic heart disease.
The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG).
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), functional capacity, global and cardiovascular mortality, and quality of life in patients undergoing coronary artery bypass surgery (CABG).
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Being tested
- Intramyocardial injection of autologous bone marrow cells
- Keywords
- Coronary artery disease, Ischemic heart disease, Angiogenesis, Cells, Cardiac surgery
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramyocardial injection of autologous bone marrow cellsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
Secondary outcomes (1)
All-cause and cardiovascular mortality during the first year; increase in VO2max, increase in quality of life, reduction in angina/heart failure functional class at 12 months; percentage of patients with a 5% increase in LVEF at 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startJan 2006
- Primary completionNov 2008 (estimated)
- Study completionNov 2008
Why it stopped: low enrollling
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Brazil
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Technology
- Investigators
- Sergio A. de Oliveira, MD, PhD, Principal investigator, Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical SchoolJose Eduardo Krieger, MD, PhD, Study director, Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362388
- Sponsor's protocol ID
- EMRTCC-ISQ
- Status last verified
- Nov 2008
- First submitted
- 8 Aug 2006
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT00362388
- Acronym / sponsor ID
- EMRTCC-ISQ
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Keywords
- Coronary artery disease, Ischemic heart disease, Angiogenesis, Cells, Cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollling
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ministry of Health, BrazilOther government
- Collaborators
- Ministry of Science and Technology
- Study start
- Jan 2006
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Aug 2006 (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.
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath.
Detailed description
Severe ischemic heart disease (IHD) remains a clinical challenge; many patients with IHD have undergone myocardial revascularization procedures (either percutaneous or surgical) but still remain symptomatic despite maximally tolerated medical therapy. Others are considered non-optimal candidates for a complete myocardial revascularization procedure due to the extension and diffuseness of the disease.
Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for many cardiovascular diseases, including heart failure, acute myocardial infarction, chronic ischemic heart disease.
The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG).
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), functional capacity, global and cardiovascular mortality, and quality of life in patients undergoing coronary artery bypass surgery (CABG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of chronic, severe, diffuse, multivessel atherosclerotic coronary artery disease (CAD) referred for CABG.
- Echocardiogram-assessed LVEF between 25 and 55% (Simpson's rule).
- Angina (or equivalent) functional class II to IV (Canadian Cardiovascular Society) despite maximally tolerated medical therapy.
- Abnormal myocardial perfusion tests:
- Non-candidates for a percutaneous coronary intervention (PCI) due to ANY of the following:
Key exclusion criteria (10 listed)
- Severe valve heart disease requiring surgical repair.
- Serologic diagnostic of Chagas' disease.
- Symptoms of heart failure, even from an ischemic etiology, in the absence of objectively documented myocardial ischemia.
- Malignant ventricular arrhythmias (like VT), unless an ICD have been placed.
- Any acute coronary syndrome in the past 3 months.
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 |
|---|---|---|
| Intramyocardial injection of autologous bone marrow cells | Procedure or surgery | – |
Primary outcome
Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
1 secondary outcome
All-cause and cardiovascular mortality during the first year; increase in VO2max, increase in quality of life, reduction in angina/heart failure functional class at 12 months; percentage of patients with a 5% increase in LVEF at 6 and 12 months.
Results and safety
The study was stopped early (reason given: low enrollling). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- Link to the Heart Institute (InCor), in São Paulo, Brazil (in Portuguese).Link provided by the sponsor.
- Link to the Instituto Nacional de Cardiologia Laranjeiras (INCL), in Rio de Janeiro, Brazil (In Portuguese).Link provided by the sponsor.
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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.
Sergio A. de Oliveira, MD, PhD principal investigator
Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School
Jose Eduardo Krieger, MD, PhD study director
Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intramyocardial injection of autologous bone marrow cells in people with Ischemic Heart Disease and Coronary Artery Disease, run by Ministry of Health, Brazil at 6 sites in Brazil.
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 10 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: stopped early, as of the sponsor's last update on 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: low enrollling). Results are not available in the source record.
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?
Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.. 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 27 Jan 2010.