Cell Therapy in Severe Chronic Ischemic Heart Disease

Phase 3

Completed

• Conditions: Angina Pectoris; Coronary Artery Disease; Chronic Ischemic Heart Disease
• Interventions: Procedure: Cell Therapy

• Registration Number: NCT01727063
• Lead Sponsor: Ministry of Health, Brazil

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-15
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cell Therapy	Cell Therapy	Intramyocardial injection of autologous bone marrow-derived cells

Primary Outcome Measures

Name	Time	Method
Increase in myocardial perfusion	1, 6 and 12 months	Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.

Secondary Outcome Measures

Name	Time	Method
Improvement in LV function	1, 6 and 12 months	LV function (global and regional) will be assessed by MRI.

Trial Locations

Locations (1)

Heart Institute; 🇧🇷 Sao Paulo, SP, Brazil