NCT00938847

Brief Summary

Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

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

February 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
Last Updated

July 14, 2009

Status Verified

July 1, 2009

Enrollment Period

1.7 years

First QC Date

July 13, 2009

Last Update Submit

July 13, 2009

Conditions

Left Ventricular Dysfunction

Keywords

left ventricular dysfunctionmyocardial infarctionleft ventricular dysfunction (LVDF) after acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration.

    12 months

Secondary Outcomes (1)

  • Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.

    12 months

Interventions

PCIDEVICE

Stent implantation after acute myocardial infarction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF \<40%
  • PCI at latest 6 hours after infarction
  • BMI \>20 kg/m² and \<30 kg/m²

You may not qualify if:

  • PCI elder than 14 days
  • relevant valvular disease
  • left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy
  • history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event
  • scheduled for CABG
  • DM Type 1 \& extensive hypercholesterinemia
  • pacemaker
  • systemic disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepios Klinik St. Georg, Departement of Cardiology

Hamburg, 20099, Germany

Location

MeSH Terms

Conditions

Ventricular Dysfunction, LeftMyocardial Infarction

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Karl-Heinz Kuck, Prof. Dr. med.

    Asklepios Klinik St. Georg, Departement of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

February 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2008

Last Updated

July 14, 2009

Record last verified: 2009-07

Locations

DE(1)