NCT00690209

Brief Summary

Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG even if substantial amount of myocardial viability is present. A value of \> 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization. Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

4.7 years

First QC Date

May 30, 2008

Last Update Submit

July 4, 2014

Conditions

Ischemic Heart Disease

Keywords

Chronic ischemic cardiomyopathy with residual viabilitysurgical coronary revascularizationstem cell therapyChronic ischemic heart diseasesevere impairment of global contractility left ventricular dilationresidual viability

Outcome Measures

Primary Outcomes (1)

  • Evolution of left ventricular volumes and contractility Evolution of left ventricular volumes and contractility

Secondary Outcomes (1)

  • Functional status

Interventions

Autologous bone marrow derived stem cells myocardial transplantationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Chronic ischemic heart disease
  • Left ventricular dilation (end systolic volume \>140 ml)
  • Poor global contractile function (ejection fraction \<40%)
  • Substantial amount of residual viability (\>30% of left ventricle)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departements of CardiacSurgery, Cardiology and Radiology

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Janusz Lipiecki, Dr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 4, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(1)