Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.
Condition: Coronary Atherosclerosis and Other Heart Disease
MeSH terms: Heart Diseases; Atherosclerosis; Ventricular Dysfunction; Coronary Artery Disease; Myocardial Ischemia; Coronary Occlusion
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Clinical trial phase III, prospective, controlled, randomized, open.

      We hypothesize work that patients with chronic coronary occlusion and poor myocardial
      viability who failed to recover ventricular function after subjecting coronary
      revascularization with new techniques of recanalization, could achieve an improvement of
      ventricular function if given further regenerative treatment with mononuclear cells from
      autologous bone marrow.

      To test this hypothesis we designed a prospective, randomized clinical trial in patients with
      recanalized chronic occlusions and ventricular dysfunction.
    

Detailed description: 
      This is a randomized, open label prospective clinical trial in which all patients diagnosed
      with chronic coronary occlusion in the Cardiology Department of Hospital Reina Sofía in
      Cordoba and Hospital Puerta del Mar in Cadiz, who meet inclusion criteria and none of the
      exclusion shall include and express their accordance with trial participation by signing the
      informed consent.

      66 patients who did not improve ventricular function measured by Magnetic resonance at least
      3 months after revascularization of chronic coronary occlusion will be included . The 66
      patients will be randomized in one to one ratio to an intervention group that received bone
      marrow mononuclear cells by intracoronary autologous (0.5 to 1 x 10 9 total cells) and a
      control group who receive only conventional medical treatment. The two groups of patients
      will be followed, in the clinical trial, for 6 months. Once the test is complete, they will
      follow according to standard clinical practice of Cardiology hospital for at least 24 months.

      Patients will be assessed by clinical and Magnetic resonance methods. All patients will be
      medically treated similarly with ACE inhibitors or angiotensine 1 receptor (AT1) receptor
      antagonists of angiotensin II, beta-blockers and diuretics.

      The main objective os the study is to determine the efficacy of intracoronary infusion of
      mononuclear cells from autologous bone marrow in patients with chronic coronary occlusion
      previously revascularized with stents in terms of improved ventricular function determined by
      magnetic resonance.

      Secondary objectives of the study are:

        1. To confirm, in view of the obtained results, the suitability of the proved protocol for
           the treatment of chronic coronary occlusion.

        2. To study changes in functional class (I-IV NYHA) of these patients compared with the
           control group.

        3. To evaluate the safety of treatment, the analysis of possible cardiac events during the
           6-month follow-up in the clinical trial and 24 months of additional clinical follow-up
           (death, myocardial infarction, repeat revascularization) compared with the control
           group.
    

Intervention name(s): Mononuclear cells from autologous bone marrow; Conventional medical treatment
Intervention type(s): Other; Drug
Intervention description(s): Mononuclear bone marrow cells autologous intracoronary
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment