NCT00984178

Brief Summary

The aim of this study is to compare the effectiveness of four different strategies for preventing the ventricular postinfarction remodelling: 1) Conventional treatment for reperfunded extensive acute myocardial infarction, 2) Autologous bone marrow stem-cells intracoronary transplantation 3) mobilization of bone marrow stem-cells induced by granulocyte colony-stimulating factors (G-CSF); and 4) combined treatment (stem-cells transplantation plus mobilization with G-CSF).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-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

November 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

February 2, 2010

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

September 24, 2009

Last Update Submit

February 1, 2010

Conditions

Reperfused Acute Myocardial Infarction

Keywords

Reperfusionacute myocardial infarctionstem cell therapyGCSFbone marrow mononuclear cellsmagnetic resonance

Outcome Measures

Primary Outcomes (1)

  • The change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance

    9 months

Secondary Outcomes (2)

  • The change in left ventricle end-dyastolyc volume, segment contractility, wall thickness and intravascular ultrasound reendothelization relative to baseline measured by magnetic resonance and other imaging techniques

    9 months

  • To determine the safety of the study procedures

    12 months

Study Arms (4)

Control group

NO INTERVENTION

standard treatment

Bone marrow mononuclear progenitors

EXPERIMENTAL

intracoronary transplantation of bone-marrow mononuclear progenitor cells

Other: Bone marrow mononuclear cells

GCSF

EXPERIMENTAL

progenitor cells mobilization through Granulocite- Colony Stimulating Factor treatment (G-CSF)

Other: Granulocite Colony Stimulating Factor treatment (G-CSF)

GCSF plus bone marrow mononuclear cells

EXPERIMENTAL

combined treatment (intracoronary transplantation plus cell mobilization with G-CSF).

Other: Granulocite Colony Stimulating Factor treatment (G-CSF)Other: Bone marrow mononuclear cells

Interventions

Granulocite Colony Stimulating Factor treatment (G-CSF)OTHER

G-CSF will be administered at a dose of 10 mcg/kg/day. The administration begins at the first 24 hours post-reperfusion, remaining for 5 days

GCSFGCSF plus bone marrow mononuclear cells
Bone marrow mononuclear cellsOTHER

Bone marrow mononuclear cells will be isolated with a Ficoll technique from 50 cc of bone marrow aspiration

Bone marrow mononuclear progenitorsGCSF plus bone marrow mononuclear cells

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 75 years
  • Acute myocardial infarction with the following characteristics:
  • Clinical symptoms of chest pain lasting \>30 minutes, unresponsive to nitroglycerin.
  • Typical myocardial enzymatical necrotic curve
  • Total summed ST-segment elevation ≥ 6 mm in 12-lead electrocardiogram.
  • Akynesis or hypokinesis in infarct-related artery area without contractility abnormalities in the rest of areas.
  • Pharmacological, mechanical or both type reperfusions (facilitated angioplasty) with evidence of normal infarcted area epicardial flow (TIMI grade 3) in the first 24 hours after the beginning of the symptoms
  • Successful repair of the infarct-related artery (residual post-stenting stenosis \< 30% by visual estimation with epicardial normal flow \[grade 3\] in the first 24 hours after the beginning of the symptoms or lack of significant residual lesions evidence (\<50% visual estimation) in infarct-related artery.
  • Lack of evidence of significant lesions in the remaining coronary vessels or adequate revascularization achieved in the first 24 hours after symptoms began.

You may not qualify if:

  • The presence of cardiogenic shock defined as sustained systolic blood pressure less than 90 mm Hg, with no response to fluids or systolic blood pressure less than 100 mm Hg with vasopressors (in absence of bradycardia)
  • Suspicion or evidence of infarct mechanical complication
  • History of sustained ventricular tachycardia or atrial fibrillation
  • Patient with cardiac defibrillator or candidate for its potential implantation.
  • Investigational drug treatment in the previous 4 weeks
  • Actual or potential use of anti-neoplastic drugs
  • Oncology antecedents in the last 5 years
  • Previous treatment with trans myocardial laser revascularization
  • Women of childbearing potential
  • Severe concomitant disease modifying patient's survival during the study
  • Inability to suspend thrombolytic treatment
  • Active bleeding or major surgery within 2 weeks forbidding the use of heparin, abciximab or antiplatelet therapy.
  • Previous malignant haematology disease (leukaemia or lymphomas) or hypercoagulability disorders (antiphospholipid syndrome, antithrombin, C-protein and S-protein or V Leiden Factor deficiency)
  • Previous known renal failure (creatinine \> 2.5 mg /dl)
  • Any kind of stroke in the last year or whenever episode of haemorrhagic stroke.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Valladolid

Valladolid, Valladolid, 47002, Spain

RECRUITING

Related Publications (1)

  • San Roman JA, Sanchez PL, Villa A, Sanz-Ruiz R, Fernandez-Santos ME, Gimeno F, Ramos B, Arnold R, Serrador A, Gutierrez H, Martin-Herrero F, Rollan MJ, Fernandez-Vazquez F, Lopez-Messa J, Ancillo P, Perez-Ojeda G, Fernandez-Aviles F. Comparison of Different Bone Marrow-Derived Stem Cell Approaches in Reperfused STEMI. A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial. J Am Coll Cardiol. 2015 Jun 9;65(22):2372-82. doi: 10.1016/j.jacc.2015.03.563.

    PMID: 26046730DERIVED

Related Links

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Francisco Fernandez-Aviles, MD, PhD

    Hospital General Universitario Gregorio Marañón

    STUDY CHAIR

Central Study Contacts

Pedro L Sanchez, MD, PhD

CONTACT

34-915865882pedrolsanchez@secardiologia.es

Francisco Fernández-Aviles, MD, PhD

CONTACT

34-915865882faviles@secardiologia.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 25, 2009

Study Start

November 1, 2005

Primary Completion

November 1, 2009

Last Updated

February 2, 2010

Record last verified: 2009-09

Locations

ES(1)