Cell Therapy in Severe Chronic Ischemic Heart Disease

Coronary Artery Disease Clinical Trial

— MiHeart  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727063
• Other study ID #: EMRTCC-ISQ2
• Status: Completed
• Phase: Phase 3
• Start date: January 2006
• Est. completion date: July 2018

Study information

• Verified date: August 2019
• Source: Ministry of Health, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Chronic Ischemic Heart Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

Procedure:
• Cell Therapy
Intramyocardial injection of autologous bone marrow-derived cells

Locations

Country	Name	City	State
Brazil	Heart Institute	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in angina functional class	Angina functional class will be determined using the Canadian Cardiovascular Society classification.	1, 6 and 12 months
Primary	Increase in myocardial perfusion	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.	1, 6 and 12 months
Secondary	Improvement in LV function	LV function (global and regional) will be assessed by MRI.	1, 6 and 12 months