Reperfused Acute Myocardial Infarction Clinical Trial
— TECAM2Official title:
Randomized Trial Comparing Intracoronary Delivery of Bone Marrow-derived Stem Cells Versus Stem Cell Mobilisation With GCSF, a Combination of Both Therapies and Conventional Treatment in Patients With Reperfused Acute Myocardial Infarction
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).
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Major surgery pending in the next year - Previously known vascular disease that prevents from catheterization. - Evidence of hypersensitivity to Filgrastim, proteins derived from E. coli or any formulation component. - Inability to give written informed consent. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario de Valladolid | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| TECAM Group | Hospital General Universitario Gregorio Marañon |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The change in left ventricular ejection fraction and left ventricular end-systolic volume relative to baseline measured by magnetic resonance | 9 months | No | |
| Secondary | 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 | No | |
| Secondary | To determine the safety of the study procedures | 12 months | Yes |