Condition category
Circulatory System
Date applied
06/10/2005
Date assigned
04/11/2005
Last edited
08/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kai Wollert

ORCID ID

Contact details

Department of Cardiology and Angiology
Hannover Medical School
Carl-Neuberg Str. 1
Hannover
30625
Germany
+49 (0)511 5324055
wollert.kai@mh-hannover.de

Additional identifiers

EudraCT number

2005-000774-46

ClinicalTrials.gov number

Protocol/serial number

EudraCT Nr. 2005-000774-46

Study information

Scientific title

Acronym

BOOST-2 (BOne marrOw transfer to enhance ST-elevation infarct regeneration-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

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)

Study design

Randomized-controlled double-blind multicenter clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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)

Updated 13/08/2010: the end date of this trial was changed from 31/12/09 to 13/12/2013.

Updated 07/01/2014: patient recruitment has been completed. The end date of this trial was changed from 13/12/2013 to 01/01/2015 .

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

06/02/2006

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 with complete follow-up

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

Trial participating centre

Department of Cardiology and Angiology
Hannover
30625
Germany

Sponsor information

Organisation

Individual Sponsor (Germany)

Sponsor details

Prof Kai Wollert
Department of Cardiology and Angiology
Hannover Medical School
Carl-Neuberg Str. 1
Hannover
30625
Germany
+49 (0)511 5324055
wollert.kai@mh-hannover.de

Sponsor type

Other

Website

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinschaft) (ref: DR 148/13-1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes