Clinical trial NCT01727063: Cell Therapy in Severe Chronic Ischemic Heart Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Ischemic Heart Disease
Coronary Artery Disease
Angina Pectoris
Keywords: Chronic ischemic heart disease
Coronary artery disease
Angina pectoris
Myocardial ischemia
Cardiac surgery
Lead sponsor: Ministry of Health, Brazil
Sponsor class: OTHER_GOV
First posted: 2012-11-15
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in myocardial perfusion
timeFrame: 1, 6 and 12 months
Secondary outcomes:
measure: Improvement in LV function
timeFrame: 1, 6 and 12 months
Other outcomes:
measure: Improvement in angina functional class
timeFrame: 1, 6 and 12 months
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute
state: SP
Study officials:
affiliation: Heart Institute
name: Jose Eduardo Krieger, MD, PhD
role: STUDY_DIRECTOR
affiliation: Heart Institute
name: Carlos Eduardo Rochitte, MD, PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1186/1745-6215-8-2.