Bone marrow transfer to enhance ST-elevation infarct regeneration-2
| ISRCTN | ISRCTN17457407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17457407 |
| EudraCT/CTIS number | 2005-000774-46 |
- Submission date
- 06/10/2005
- Registration date
- 04/11/2005
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Kai Wollert
Scientific
Scientific
Department of Cardiology and Angiology
Hannover Medical School
Carl-Neuberg Str. 1
Hannover
30625
Germany
| Phone | +49 (0)511 5324055 |
|---|---|
| wollert.kai@mh-hannover.de |
Study information
| Study design | Randomized-controlled double-blind multicenter clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | BOne marrOw transfer to enhance ST-elevation infarct regeneration-2 (BOOST-2) |
| Study acronym | BOOST-2 |
| Study hypothesis | BOOST-2 examines three principle hypotheses: 1st hypothesis: An intracoronary infusion of high-dose, non-irradiated Bone Marrow Cells (BMCs) is superior to an intracoronary infusion of control cells 2nd set of hypotheses: 1. An intracoronary infusion of high-dose BMCs (irradiated and non-irradiated) is superior to an intracoronary infusion of control cells 2. An intracoronary infusion of low-dose BMCs (irradiated and non-irradiated) is superior to an intracoronary infusion of control cells 3. Low-dose BMC-transfer (irradiated and non-irradiated) is not inferior to high-dose BMC-transfer (irradiated and non-irradiated) 3rd set of hypotheses: 1. An intracoronary infusion of non-irradiated BMCs (low-dose and high-dose) is superior to an intracoronary infusion of control cells 2. An intracoronary infusion of irradiated BMCs (low-dose and high-dose) is superior to an intracoronary infusion of control cells 3. Irradiated BMC-transfer (low-dose and high-dose) is not inferior to non-irradiated BMC-transfer (low-dose and high-dose) |
| Ethics approval(s) | Added as of 03/08/2007: The final study protocol (version 7), has been approved by the Ethics Committee of Hannover Medical School in Hannover, Germany on 03/02/2006 (No. 3812M) |
| Condition | Acute ST-Elevation Myocardial Infarction (STEMI) |
| Intervention | BOOST-2 is a randomized-controlled, double-blind, multicenter clinical trial investigating the effects of intracoronary nucleated BMC-transfer in patients after Acute Myocardial Infarction (AMI). BOOST-2 will investigate whether intracoronary BMC-transfer will have an effect on Left Ventricular (LV) functional and structural regeneration and have an impact on clinical endpoints as compared to a placebo cell infusion (erythrocytes only). BOOST-2 will address a number of biological and procedural issues. Irradiation of BMCs will be performed in two groups of patients just prior to intracoronary transfer. This study arm will reveal whether replication-competent cells (non-irradiated cells) are required for regeneration after AMI. In addition, BOOST-2 will address the question whether dose matters in BMC-therapy for AMI. BOOST-2 has six groups of patients: 1. Low dose, placebo cell infusion (20 patients) 2. High dose, placebo cell infusion (20 patients) 3. Low dose, non-irradiated BMC infusion (40 patients) 4. High dose, non-irradiated BMC infusion (40 patients) 5. Low dose, irradiated BMC infusion (40 patients) 6. High dose, irradiated BMC infusion (40 patients) |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Change in LV Ejection Fraction (LVEF) from baseline to 6 months follow-up (assessed by MRI). The primary endpoint will be analyzed separately in four subgroups: 1. Patients with a baseline LVEF smaller/larger than the median of the study population (assessed by MRI) 2. Patients undergoing PCI/stenting earlier/later than the median in the study population 3. Patients with an infarct size smaller/larger than the median of the study population (assessed by late contrast enhancement MRI) 4. Patients with a functional regenerative capacity of the infused bone marrow cells smaller/larger than the median of the study population Additional subgroups will be analyzed in an exploratory manner. |
| Secondary outcome measures | 1. Change in LVEF from baseline to 18 months follow-up (assessed by MRI) 2. Changes in LV end-diastolic volume index, LV end-systolic volume index, infarct size (late enhancement), regional LV function, and myocardial perfusion from baseline to 6 and 18 months follow-up (assessed by MRI) 3. Changes in LV diastolic function from baseline to 6 and 18 months follow-up (echocardiography) 4. Exercise capacity at 6 and 18 months follow-up (cardiopulmonary exercise testing) 5. Quality of life (Minnesota Living with Heart Failure Questionnaire) and New York Heart Association (NYHA) class at 6 and 18 months follow-up 6. Combined clinical endpoint of death and hospitalization with heart failure |
| Overall study start date | 06/02/2006 |
| Overall study end date | 01/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 with complete follow-up |
| Total final enrolment | 153 |
| Participant inclusion criteria | Inclusion criteria amended as of 03/08/2007: The following is the new definition of inclusion criteria that has been effective since July 4th, 2007: 1. Age 30 years or older 2. First time STEMI 3. Time from symptom onset to reperfusion of >3 hours and baseline LV ejection fraction <57% as assessed by Magnetic Resonance Imaging (MRI) OR time from symptom onset to reperfusion between 1.5 and 3 hours and baseline LV ejection fraction <52% as assessed by MRI 4. Successful Percutaneous Coronary Intervention (PCI) and stent implantation of the infarct vessel (TIMI 2 or 3) 5. Severe hypokinesia or akinesia of >2/3 of the Left Ventricular (LV) anteroseptal, lateral, and/or inferior wall, as shown by LV angiography immediately after PCI/Stent 6. No previous infarction (late enhancement) in another territory as assessed by MRI 7.Written informed consent Inclusion criteria provided at time of registration: 1. Age 30 years or older 2. First time STEMI 3. Time from symptom onset to reperfusion of >3 hours 4. Successful Percutaneous Coronary Intervention (PCI) and stent implantation of the infarct vessel (TIMI 2 or 3) 5. Severe hypokinesia or akinesia of >2/3 of the Left Ventricular (LV) anteroseptal, lateral, and/or inferior wall, as shown by LV angiography immediately after PCI/Stent 6. Baseline LV ejection fraction <57% as assessed by Magnetic Resonance Imaging (MRI) 7. No previous infarction (late enhancement) in another territory as assessed by MRI 8. Written informed consent |
| Participant exclusion criteria | 1. Multi-vessel coronary artery disease requiring repeat PCI or coronary bypass 2. Pulmonary edema requiring intubation, cardiogenic shock 3. Pregnancy or unreliable contraception 4. Terminal illness or cancer 5. Advanced hepatic or renal disease, acute or chronic hepatitis, or Human Immunodeficiency Virus (HIV) infection 6. Acute systemic infection/inflammation or fever 7. Severe thrombocytopenia or anemia, coagulopathy 8. Known hypersensitivity or allergy to parts of the cell preparation reagents or other applied medicinal products (e.g. midazolam, etomidate) 9. Cardiac pacemaker or implantable cardioverter-defibrillator, claustrophobia and severe obesity 10. Patients participating in another investigational trial within the last 30 days 11. Any other condition which, in the judgement of the investigator, might increase the risk to the patient or preclude the satisfactory ability to collect trial relevant experimental or clinical data 12. Patients who were exposed to ionizing radiation within the last 10 years |
| Recruitment start date | 06/02/2006 |
| Recruitment end date | 01/01/2015 |
Locations
Countries of recruitment
- Bulgaria
- Germany
- Norway
Study participating centre
Hannover Medical School
Hannover
30625
Germany
30625
Germany
Sponsor information
Individual Sponsor (Germany)
Other
Other
Prof Kai Wollert
Department of Cardiology and Angiology
Hannover Medical School
Carl-Neuberg Str. 1
Hannover
30625
Germany
| Phone | +49 (0)511 5324055 |
|---|---|
| wollert.kai@mh-hannover.de |
Funders
Funder type
Research organisation
German Research Foundation (Deutsche Forschungsgemeinschaft) (ref: DR 148/13-1)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/10/2017 | 29/05/2020 | Yes | No |
Editorial Notes
29/05/2020: Publication reference and total final enrolment number added.
07/01/2014: Patient recruitment has been completed. The overall trial end date was changed from 13/12/2013 to 01/01/2015.
13/08/2010: The overall trial end date was changed from 31/12/09 to 13/12/2013.
