Chronic Ischemic Heart DiseasePhase 3MiHeartNCT01727063
Cell Therapy in Severe Chronic Ischemic Heart Disease
A Phase 3 study testing Cell Therapy in people with Chronic Ischemic Heart Disease and Coronary Artery Disease, run by Ministry of Health, Brazil at 1 site in Brazil.
Trial summary
Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Ischemic Heart Disease, Coronary Artery Disease, Angina Pectoris
- What is being tested?
- Cell Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Jul 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptoms of angina or angina equivalent
- documented coronary artery disease (invasive angiography)
- documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
- unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds
Who cannot join
- severe LV dysfunction (EF < 25% on echo)
- short life expectacy (below < 1 year)
- diagnosis of cancer in the past 5 years
- diagnosis of hematological diseases
- diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
- diagnosis of acute coronary syndrome in the past 3 months
- diagnosis of chronic kidney disease stage V requiring chronic dialysis
Trial locations and contacts
1 site in 1 country.
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
Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.
This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.
Read the detailed description
All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.
During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.
- Being tested
- Cell Therapy
- Keywords
- Chronic ischemic heart disease, Coronary artery disease, Angina pectoris, Myocardial ischemia, Cardiac surgery
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell TherapyProcedure or surgery
Intramyocardial injection of autologous bone marrow-derived cells
| Study group | Role | What they receive |
|---|---|---|
| Cell Therapy | Experimental | Intramyocardial injection of autologous bone marrow-derived cells Receives: Procedure: Cell Therapy |
| Placebo | No intervention | Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in myocardial perfusion
Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.
Measured: 1, 6 and 12 months
Secondary outcomes (1)
Improvement in LV function
LV function (global and regional) will be assessed by MRI.
Measured: 1, 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 posted15 Nov 2012 (estimated)
- Study startJan 2006
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Model description
- Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luis Henrique W Gowdak, MD, PhD, Ministry of Health, Brazil
- Investigators
- Jose Eduardo Krieger, MD, PhD, Study director, Heart InstituteCarlos Eduardo Rochitte, MD, PhD, Study chair, Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727063
- Sponsor's protocol ID
- EMRTCC-ISQ2
- Acronym
- MiHeart
- Status last verified
- Aug 2019
- First submitted
- 12 Nov 2012
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.
PubMed 17233910Gowdak LHW, Schettert IT, Rochitte CE, de Carvalho LP, Vieira MLC, Dallan LAO, de Oliveira SA, Cesar LAM, Brito JOR, Guarita-Souza LC, de Carvalho ACC, Krieger JE. Additional improvement in regional myocardial ischemia after intracardiac injection of bone marrow cells during CABG surgery. Front Cardiovasc Med. 2023 Feb 7;10:1040188. doi: 10.3389/fcvm.2023.1040188. eCollection 2023.
PubMed 36824456
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. 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
- NCT01727063
- Acronym / sponsor ID
- MiHeart / EMRTCC-ISQ2
- Keywords
- Chronic ischemic heart disease, Coronary artery disease, Angina pectoris, Myocardial ischemia, Cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ministry of Health, BrazilOther government
- Study start
- Jan 2006 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Nov 2012 (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.
Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.
This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.
Detailed description
All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.
During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
| Arm | Type | Receives |
|---|---|---|
| Cell Therapy | Experimental | Procedure: Cell TherapyIntramyocardial injection of autologous bone marrow-derived cells |
| Placebo | No intervention | –Saline injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptoms of angina or angina equivalent
- documented coronary artery disease (invasive angiography)
- documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
- unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds
Key exclusion criteria (7 listed)
- severe LV dysfunction (EF < 25% on echo)
- short life expectacy (below < 1 year)
- diagnosis of cancer in the past 5 years
- diagnosis of hematological diseases
- diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
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 |
|---|---|---|
| Cell TherapyIntramyocardial injection of autologous bone marrow-derived cells | Procedure or surgery | Cell Therapy |
Primary outcome
Increase in myocardial perfusion
Time frame: 1, 6 and 12 months
Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.
1 secondary outcome
Improvement in LV function
Time frame: 1, 6 and 12 months
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 30 Aug 2019.
- Background: PubMed 17233910Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.
- Derived from this study: PubMed 36824456Gowdak LHW, Schettert IT, Rochitte CE, de Carvalho LP, Vieira MLC, Dallan LAO, de Oliveira SA, Cesar LAM, Brito JOR, Guarita-Souza LC, de Carvalho ACC, Krieger JE. Additional improvement in regional myocardial ischemia after intracardiac injection of bone marrow cells during CABG surgery. Front Cardiovasc Med. 2023 Feb 7;10:1040188. doi: 10.3389/fcvm.2023.1040188. eCollection 2023.
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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.
Jose Eduardo Krieger, MD, PhD study director
Heart Institute
Carlos Eduardo Rochitte, MD, PhD study chair
Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cell Therapy in people with Chronic Ischemic Heart Disease and Coronary Artery Disease, run by Ministry of Health, Brazil at 1 site 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 4 inclusion and 7 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 30 Aug 2019. 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 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 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?
Increase in myocardial perfusion (time frame: 1, 6 and 12 months). 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 NCT01727063, which also lists 2 linked publications.
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 30 Aug 2019.