Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

Phase 2TerminatedNCT00908622

Clinica Universidad de Navarra, Universidad de Navarra38 enrolled

Overview

The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.

Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Old Myocardial Infarction

Interventions

Percutaneous autologous myoblast implantationPROCEDURE

Endocavity implantation of autologous myoblasts

Cardiac revascularizationPROCEDURE

Cardiac revascularization

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with diagnosis of myocardial infarction, absence of viability. * Ejection fraction under 40% or 45% in symptomatic patients * Aged from 30-80 years old. * Negative pregnancy test (women of childbearing age) * Informed consent granted Exclusion Criteria: * Prior history of tachycardia or ventricular fibrillation (except in the acute phase of MI). * Myocardial infarction with more than 10 years of evolution. * Patients positive for HIV, HBV or HCB. * Patients with organ dysfunction: liver and kidney function * History of cancer or prior treatment with chemotherapy. * The patient should not suffer from any concomitant severe and/or uncontrolled medical condition. * Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol. * Pregnant or beast feeding women.

Locations (2)

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Ejection fraction and wall motion score index measured with M-mode and echocardiography

Time frame: 12 months after surgery

Secondary Outcomes

Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population

Time frame: 12 month after surgery

Viability measured with echocardigraphy and magnetic resonance in the ITT population

Time frame: 12 month after surgery

Incidence of cardiac arrythmias in the ITT population

Time frame: 12 month after surgery

Ejection fraction measured with echocardiography in the ITT population

Time frame: 12 month after surgery

Data from ClinicalTrials.gov

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