NCT00289822

Brief Summary

Impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy. The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (\>= 3 months) myocardial infarction.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Jan 2002

Typical duration for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

November 30, 2006

Status Verified

February 1, 2006

First QC Date

February 8, 2006

Last Update Submit

November 29, 2006

Conditions

Coronary Artery Disease

Keywords

chronic heart failuremyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Change in global left ventricular function (measured by quantitative left ventricular angiography)

Secondary Outcomes (4)

  • Quantitative parameters of regional left ventricular function of the target area

  • changes in left ventricular volumes

  • functional status as assessed by NYHA classification

  • event-free survival after 4 months follow-up

Interventions

intracoronary infusion of progenitor cellsDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 to 80
  • Patients post-myocardial infarction (\> 3 months old) or with diffuse ischemic CHD
  • Signed informed consent

You may not qualify if:

  • \- Existing neoplastic disease or signs of tumor recurrence within the last 5 years
  • Active infection
  • Active internal bleeding
  • Stroke within the past 2 years
  • Surgery or trauma within the past two months
  • Uncontrolled hypertension over 160/100
  • Arteriovenous malformations or aneurysms
  • HIV infection
  • Signs of significant kidney or liver failure (creatinine \> 2.0 mg/dL, GOT \> 2 x upper standard value)
  • Thrombopenia (\< 100,000)
  • Anemia (hemoglobin \< 8.5 g/dL)
  • Mental retardation
  • Participation in another clinical study
  • Women of childbearing age
  • Chronic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

J. W. Goethe University Hospitals

Frankfurt, 60590, Germany

Location

Related Publications (3)

  • Assmus B, Honold J, Schachinger V, Britten MB, Fischer-Rasokat U, Lehmann R, Teupe C, Pistorius K, Martin H, Abolmaali ND, Tonn T, Dimmeler S, Zeiher AM. Transcoronary transplantation of progenitor cells after myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1222-32. doi: 10.1056/NEJMoa051779.

    PMID: 16990385RESULT

  • De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.

    PMID: 23362308DERIVED

  • Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.

    PMID: 22936827DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Andreas M Zeiher, MD

    J. W. Goethe University Hospitals

    PRINCIPAL INVESTIGATOR

  • Volker Schaechinger, MD

    J. W. Goethe University Hospitals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 10, 2006

Study Start

January 1, 2002

Study Completion

January 1, 2005

Last Updated

November 30, 2006

Record last verified: 2006-02

Locations

DE(1)