Intramyocardial Delivery of Autologous Bone Marrow

Refractory Angina Clinical Trial

Official title: Intramyocardial Delivery of Autologous Bone Marrow

Status Suspended

Clinical Trial Summary

A randomized study to assess the safety, feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells in patients with refractory angina pectoris.

Clinical Trial Description

Primary Endpoint: Incidence of major adverse cardiac events (MACE) at 30 days. MACE is defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures (percutaneous or surgical), and peri-procedural complications (that is, left ventricular perforation with hemodynamic consequences requiring pericardiocentesis, and stroke).

Incidence of MACE at 3, 6 and 12 months

Secondary Endpoints:

• Change in Canadian Cardiovascular Society (CCS) angina classification score from baseline to 12 months

• Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire

• Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline, to 6 months and to 12 months

• Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment.

• SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution for baseline to 1, 6 and 12 months

• Change in angiographic collateral score at 6 months

• Change in global and regional myocardial contractility (assessed by echocardiography) at baseline, 6 and 12 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractory Angina

• NCT number: NCT00820586
• Study type: Interventional
• Source: IRCCS San Raffaele
• Status: Suspended
• Phase: Phase 2
• Start date: May 2007
• Completion date: December 2018