Selected autologous bone marrow cell transplant following trans-mural myocardial infarction in patients undergoing coronary surgery: A prospective, double-blind, randomised controlled trial

nited Bristol Healthcare NHS Trust (UK)0 sites60 target enrollmentJuly 10, 2008

Overview

No summary available.

Registry

who.int

Start Date

July 10, 2008

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

nited Bristol Healthcare NHS Trust (UK)

•1\. Patients of either sex, aged 16 years or over and under 80 years
•2\. Recent (\>10 days and 3 months) anterior ST\-Segment Elevation Myocardial Infarction (STEMI) who have not undergone primary angioplasty
•3\. Cardiac magnetic resonance imaging (MRI) documented anterior myocardial infarction (MI) with a transmurality of \>\= 50% wall thickness in at least 1 segment of the LAD territory
•4\. Requirement for coronary artery bypass graft (CABG) alone to bypass stenoses or occlusions of the left anterior descending artery (LAD) territory and any other territory as dictated by baseline coronary angiography
•5\. Absence of LV dilation (LV end systolic volume index \<60 ml/m^2\)

•1\. Presence of cardiogenic shock or presence of acute left and/or right\-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
•2\. Cardiac MRI documented MI transmurality of \<50% wall thickness in all 7 segments of the LAD territory
•3\. Presence of LV dilatation (LV end systolic volume index \>60 ml/m^2\)
•4\. Cardiomyopathy secondary to a reversible cause
•5\. Known active infection
•6\. Chronic inflammatory disease
•7\. Serum creatinine \>\= 200 mmol/L
•8\. Contraindications for bone marrow aspiration
•9\. Female subjects of childbearing potential
•10\. Emergency operation for unstable angina