Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)

Ministry of Health, Brazil

Status and phase

Completed

Phase 3

Conditions

Coronary Artery Disease

Angina Pectoris

Chronic Ischemic Heart Disease

Treatments

Procedure: Cell Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01727063

EMRTCC-ISQ2

Details and patient eligibility

About

Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.

This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

Full description

All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.

During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Enrollment

143 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

symptoms of angina or angina equivalent
documented coronary artery disease (invasive angiography)
documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds

Exclusion criteria

severe LV dysfunction (EF < 25% on echo)
short life expectacy (below < 1 year)
diagnosis of cancer in the past 5 years
diagnosis of hematological diseases
diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
diagnosis of acute coronary syndrome in the past 3 months
diagnosis of chronic kidney disease stage V requiring chronic dialysis