NCT01748383

Brief Summary

The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

8 years

First QC Date

December 7, 2012

Last Update Submit

December 13, 2012

Conditions

Vascular DiseasesCardiovascular DiseasesAcute Myocardial Infarction

Keywords

Bone marrow cellsAcute myocardial infarctionTransplantation of autologous mononuclearTransplantation of autologous CD133 + cells

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction (Echo)

    for an average of 7 years

Secondary Outcomes (7)

  • incidence of cardiovascular death

    7 years

  • incidence of the recurrent myocardial infarction

    7 years

  • incidence of the angina

    7 years

  • incidence of the heart failure

    7 years

  • incidence of the stroke

    7 years

  • +2 more secondary outcomes

Study Arms (3)

Transplantation of BMMCs

EXPERIMENTAL

Autologous BMCs aspiration and transplantation of these cells

Procedure: Transplantation of BMMCs

Transplantation of CD 133+ cells

EXPERIMENTAL

Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells

Procedure: Transplantation of CD 133+ cells

stenting of IRA

ACTIVE COMPARATOR

The only stenting of IRA

Procedure: stenting of IRA

Interventions

Transplantation of BMMCsPROCEDURE

The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.

Transplantation of BMMCs
Transplantation of CD 133+ cellsPROCEDURE

The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation.

Transplantation of CD 133+ cells
stenting of IRAPROCEDURE

The only stent implantation

stenting of IRA

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and to 75 Years
  • Informed consent
  • First STEMI
  • Term admission to an intensive care unit in the first 24 hours of onset
  • Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction

You may not qualify if:

  • Atrial fibrillation, a permanent form Valvular heart disease
  • Severe comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific and Research Institution of Cardiology of Siberian Department of RAMS

Tomsk, 634012, Russia

Location

MeSH Terms

Conditions

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Vyacheslav Ryabov, MD, PhD

    Scientific and Research Institution of Cardiology of Siberian Department of RAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leading researcher of Emergency Cardiology Department

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 12, 2012

Study Start

September 1, 2005

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

RU(1)