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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01727063
Other study ID # EMRTCC-ISQ2
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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