Acute Myocardial InfarctionBMC registryNCT00962364
Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
An observational study of Acute Myocardial Infarction and Ischemic Cardiomyopathy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Ischemic Cardiomyopathy, Dilated Cardiomyopathy
- What is being tested?
- autologous bone marrow-derived cells
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2001to Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from heart disease with consecutive signs of heart failure, treated in our clinic or being referred for cell therapy
Who may be able to join
None listed.
Who cannot join
- none, all patients meeting the inclusion criteria will be eligible.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cardiology, Department of Internal Medicine III
Frankfurt, 60590
About this study
Official title: Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease
This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells.
Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing.
Read more
Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation.
The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.
Read the detailed description
In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:
- periodic physical examination and blood tests
- non-invasive imaging studies may include echocardiography and magnetic resonance imaging
- electrocardiogram at rest and during treadmill testing (may include spiroergometry testing)
- interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias
- Conditions
- Acute Myocardial Infarction, Ischemic Cardiomyopathy, Dilated Cardiomyopathy, Heart Failure
- Being tested
- autologous bone marrow-derived cells
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow-derived cellsBiological
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| AMI | Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells Receives: Biological: autologous bone marrow-derived cells | |
| ICM | Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells Receives: Biological: autologous bone marrow-derived cells | |
| DCM | Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells Receives: Biological: autologous bone marrow-derived cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startOct 2001
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. M. Zeiher, Johann Wolfgang Goethe University Hospital
- Investigators
- Andreas M Zeiher, Prof. Dr, Principal investigator, Cardiology, Goethe University Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962364
- Sponsor's protocol ID
- 201-01-BMC-Reg
- Acronym
- BMC registry
- Status last verified
- Feb 2020
- First submitted
- 19 Aug 2009
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Assmus B, Fischer-Rasokat U, Honold J, Seeger FH, Fichtlscherer S, Tonn T, Seifried E, Schachinger V, Dimmeler S, Zeiher AM; TOPCARE-CHD Registry. Transcoronary transplantation of functionally competent BMCs is associated with a decrease in natriuretic peptide serum levels and improved survival of patients with chronic postinfarction heart failure: results of the TOPCARE-CHD Registry. Circ Res. 2007 Apr 27;100(8):1234-41. doi: 10.1161/01.RES.0000264508.47717.6b. Epub 2007 Mar 22.
PubMed 17379833Luu B, Leistner DM, Herrmann E, Seeger FH, Honold J, Fichtlscherer S, Zeiher AM, Assmus B. Minute Myocardial Injury as Measured by High-Sensitive Troponin T Serum Levels Predicts the Response to Intracoronary Infusion of Bone Marrow-Derived Mononuclear Cells in Patients With Stable Chronic Post-Infarction Heart Failure: Insights From the TOPCARE-CHD Registry. Circ Res. 2017 Jun 9;120(12):1938-1946. doi: 10.1161/CIRCRESAHA.116.309938. Epub 2017 Mar 28.
PubMed 28351842Honold J, Fischer-Rasokat U, Seeger FH, Leistner D, Lotz S, Dimmeler S, Zeiher AM, Assmus B. Impact of intracoronary reinfusion of bone marrow-derived mononuclear progenitor cells on cardiopulmonary exercise capacity in patients with chronic postinfarction heart failure. Clin Res Cardiol. 2013 Sep;102(9):619-25. doi: 10.1007/s00392-013-0574-1. Epub 2013 Apr 24.
PubMed 23612920De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.
PubMed 23362308Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
PubMed 22936827Xu Q, Seeger FH, Castillo J, Iekushi K, Boon RA, Farcas R, Manavski Y, Li YG, Assmus B, Zeiher AM, Dimmeler S. Micro-RNA-34a contributes to the impaired function of bone marrow-derived mononuclear cells from patients with cardiovascular disease. J Am Coll Cardiol. 2012 Jun 5;59(23):2107-17. doi: 10.1016/j.jacc.2012.02.033.
PubMed 22651868
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease
- ClinicalTrials.gov ID
- NCT00962364
- Acronym / sponsor ID
- BMC registry / 201-01-BMC-Reg
- Conditions
- Acute Myocardial Infarction, Ischemic Cardiomyopathy, Dilated Cardiomyopathy, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Aug 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.
This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells.
Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing.
Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation.
The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.
Detailed description
In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:
- periodic physical examination and blood tests
- non-invasive imaging studies may include echocardiography and magnetic resonance imaging
- electrocardiogram at rest and during treadmill testing (may include spiroergometry testing)
- interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMI | – | Biological: autologous bone marrow-derived cellsPatients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells |
| ICM | – | Biological: autologous bone marrow-derived cellsPatients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells |
| DCM | – | Biological: autologous bone marrow-derived cellsPatients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from heart disease with consecutive signs of heart failure, treated in our clinic or being referred for cell therapy
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- none, all patients meeting the inclusion criteria will be eligible.
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 cellsautologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia | Biological | AMI, DCM, ICM |
Primary outcome
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Results publication: PubMed 17379833Assmus B, Fischer-Rasokat U, Honold J, Seeger FH, Fichtlscherer S, Tonn T, Seifried E, Schachinger V, Dimmeler S, Zeiher AM; TOPCARE-CHD Registry. Transcoronary transplantation of functionally competent BMCs is associated with a decrease in natriuretic peptide serum levels and improved survival of patients with chronic postinfarction heart failure: results of the TOPCARE-CHD Registry. Circ Res. 2007 Apr 27;100(8):1234-41. doi: 10.1161/01.RES.0000264508.47717.6b. Epub 2007 Mar 22.
- Derived from this study: PubMed 28351842Luu B, Leistner DM, Herrmann E, Seeger FH, Honold J, Fichtlscherer S, Zeiher AM, Assmus B. Minute Myocardial Injury as Measured by High-Sensitive Troponin T Serum Levels Predicts the Response to Intracoronary Infusion of Bone Marrow-Derived Mononuclear Cells in Patients With Stable Chronic Post-Infarction Heart Failure: Insights From the TOPCARE-CHD Registry. Circ Res. 2017 Jun 9;120(12):1938-1946. doi: 10.1161/CIRCRESAHA.116.309938. Epub 2017 Mar 28.
- Derived from this study: PubMed 23612920Honold J, Fischer-Rasokat U, Seeger FH, Leistner D, Lotz S, Dimmeler S, Zeiher AM, Assmus B. Impact of intracoronary reinfusion of bone marrow-derived mononuclear progenitor cells on cardiopulmonary exercise capacity in patients with chronic postinfarction heart failure. Clin Res Cardiol. 2013 Sep;102(9):619-25. doi: 10.1007/s00392-013-0574-1. Epub 2013 Apr 24.
- Derived from this study: PubMed 23362308De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.
- Derived from this study: PubMed 22936827Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
- Derived from this study: PubMed 22651868Xu Q, Seeger FH, Castillo J, Iekushi K, Boon RA, Farcas R, Manavski Y, Li YG, Assmus B, Zeiher AM, Dimmeler S. Micro-RNA-34a contributes to the impaired function of bone marrow-derived mononuclear cells from patients with cardiovascular disease. J Am Coll Cardiol. 2012 Jun 5;59(23):2107-17. doi: 10.1016/j.jacc.2012.02.033.
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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.
Andreas M Zeiher, Prof. Dr principal investigator
Cardiology, Goethe University Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Ischemic Cardiomyopathy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 0 inclusion and 1 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 26 Feb 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 Germany. 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.
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?
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?
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease (time frame: 10 years). 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 NCT00962364, which also lists 6 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 26 Feb 2020.